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Study Data Tabulation Model

Public Review Version 1.6

Prepared by the
CDISC Submission Data Standards Team
and CDISC SDTM Governance Committee 

 

Notes to Readers

This is the Public Review version 1.6 of the Study Data Tabulation Model Document (SDTM). This document includes additional variables related to developmental and reproductive toxicology (DART) animal studies. A full description of all changes from the prior version is provided in Section 7.

Notes to Reviewers

New Variables are marked with " NEW". This marking will not be retained in the final published version.



Revision History

Date

Version

2017-04-01Version 1.6 Public Review Version

2016-05-16

Version 1.5 Final

2013-11-26

Version 1.4 Final

2012-07-16

Version 1.3 Final

2008-11-12

Version 1.2 Final

2005-04-28

Version 1.1 Final

2004-06-25

Version 1.0 Final

© 2017 Clinical Data Interchange Standards Consortium, Inc. All rights reserved. See Representations and Warranties, Limitations of Liability, and Disclaimers.


Contents

Tables

Table 2.2.1: Interventions — Topic and Qualifier Variables — One Record per Constant-Dosing Interval or Intervention Episode
Table 2.2.2: Events — Topic and Qualifier Variables — One Record per Event 
Table 2.2.3: Findings — Topic and Qualifier Variables — One Record per Finding 
Table 2.2.3.1: Findings About — Additional Qualifiers 
Table 2.2.4: All Observation Classes — Identifiers 
Table 2.2.5: All Observation Classes — Timing Variables 
Table 2.2.6: Subject Demographics Domain Variables 
Table 2.2.7: Comments Domain Variables 
Table 2.2.8: Subject Elements — One Record per Actual Element per Subject 
Table 2.2.9: Subject Visits — One Record per Subject Visit, per Subject 
Table 2.2.10: Subject Disease Milestones — One Record per Disease Milestone, per Subject 
Table 2.2.12: Domain-Specific Variables for General Observation Class Domains 
Table 3.1.1: Trial Elements — One Record per Trial Element 
Table 3.1.2: Trial Arms — One Record per Planned Element per Arm 
Table 3.1.3: Trial Visits — One Record per Planned Trial Visit 
Table 3.1.4: Trial Sets — One Record per Trial Set Parameter 
Table 3.2: Trial Inclusion/Exclusion — One Record per Trial Inclusion or Exclusion Criterion 
Table 3.3: Trial Summary — One Record per Trial Summary Parameter 
Table 3.4: Trial Disease Assessments — One Record per Planned Constant Assessment Period 
Table 3.5: Trial Disease Milestones — One record per Disease Milestone type 
Table 4.1.1: RELREC Dataset 
Table 4.1.2: SUPPQUAL Dataset 
Table 4.1.3: POOLDEF Dataset 
Table 4.1.4: RELSUB Dataset 
Table 5.1.1: Associated Persons Data — Identifier Variables 
Table 5.2: APRELSUB Dataset


Introduction

Purpose

This document describes the Study Data Tabulation Model (SDTM), which defines a standard structure for study data tabulations that are to be submitted as part of a product application to a regulatory authority such as the United States Food and Drug Administration (FDA). This document is based on material originally prepared by the Submissions Data Standards (SDS) Team of the Clinical Data Interchange Standards Consortium (CDISC), but is now maintained by the SDTM Governance Committee (SGC) of CDISC. This document, which supersedes all prior versions, includes numerous changes from the prior SDTM v1.5, which are described in Section 7.1, Changes from SDTM v1.5 to SDTM v1.6.

Data tabulation datasets are one of four ways to represent the human subject Case Report Tabulation (CRT) and equivalent animal data submitted to the FDA. CRTs are also submitted in the format of subject profiles, data listings, and analysis datasets. One benefit to industry of submitting data tabulation datasets that conform to the standard structure is that it minimizes the need to submit the same data in multiple formats.

The availability of standard submission data may provide many benefits to regulatory reviewers. Reviewers can now be trained in the principles of standardized datasets and the use of standard software tools, and thus be able to work with the data more effectively with less preparation time. Another benefit of the standardized datasets is that they can provide support for the FDA's efforts to develop a repository for all submitted studies and a suite of standard review tools to access, manipulate, and view the study data.

This document is intended for companies and individuals involved in the collection, preparation, and analysis of study data submitted to regulatory authorities. Guidance, specifications, and regulations for the application of this model will be provided separately by regulatory authorities. Audiences are advised to refer to these documents before preparing a regulatory submission based on the SDTM.

Relationship to Prior CDISC Models

This document is a successor of what was known in prior versions as the CDISC Submission Data Standards or Submission Domain Models. While SDTM v1.0 was designated as the first implementation-ready version for clinical studies involving human drug products, improvements and enhancements have been incorporated in subsequent versions to support a broader range of regulated products, including the needs of non-clinical animal toxicity studies. Efforts will continue to further evaluate the model for human and animal studies involving other regulated products including food additives; therapeutic biologics; blood derivatives; vaccines; cellular, tissue, and gene therapy; and devices. Implementation guides for applying the model to each type of data and guidance on controlled terminology will be published separately.

Significant Changes from Prior Versions

The SDTM has been designed for backward compatibility; datasets prepared with v1.6 should be fully compatible with prior versions. In most cases, this means that later versions may add new variables or correct textual errors, but do not eliminate variables or structures incorporated in prior versions. There are, however, isolated instances where some older variables may be deprecated in favor of newer, more functional variables. SDTM v1.6 does not include any proposed deprecated variables.

The following new sections and tables have been added:

  • Table 2.2.11: Subject Repro Stages
  • Table 3.1.5: Trial Repro Stages 
  • Table 3.1.6: Trial Repro Paths

New variables have been added to the following sections:

  • Table 2.2.5 Timing Variables
  • Table 2.2.6 - Demographics

An additional column, Format, has been added to Special Purpose Datasets (CO, DM, SE, SM, SV) and the Trial Design Datasets (TE and TD). The purpose of this column is to provide information on variables which use ISO 8601 and other formats in a structured, consistent way.

Model Fundamentals

Model Concepts and Terms

The SDTM provides a general framework for describing the organization of information collected during human and animal studies and submitted to regulatory authorities. The model is built around the concept of observations, which consist of discrete pieces of information collected during a study. Observations normally correspond to rows in a dataset. A collection of observations on a particular topic is considered a domain. For example, "Subject 101 had mild nausea starting on Study Day 6" is an observation belonging to the Adverse Events domain in a clinical trial.

Each observation can be described by a series of named variables. Each variable, which normally corresponds to a column in a dataset, can be classified according to its Role. A Role describes the type of information conveyed by the variable about each distinct observation and how it can be used. SDTM variables can be classified into five major roles:

  • Identifier variables, such as those that identify the study, the subject (individual human or animal or group of individuals) involved in the study, the domain, and the sequence number of the record.
  • Topic variables, which specify the focus of the observation (such as the name of a lab test).
  • Timing variables, which describe the timing of an observation (such as start date and end date).
  • Qualifier variables, which include additional illustrative text, or numeric values that describe the results or additional traits of the observation (such as units or descriptive adjectives).
  • Rule variables, which express an algorithm or executable method to define start, end, or looping conditions in the Trial Design model.

Domain-specific variables, a concept introduced in SDTM v1.5, are for use in a limited number of designated domains and will be identified in the appropriate implementation guide. The variable names include the specific domain prefix. Table 2.2.12 lists the proposed domain-specific variables.

The set of Qualifier variables can be further categorized into five sub-classes:

  • Grouping Qualifiers are used to group together a collection of observations within the same domain. Examples include --CAT and --SCAT.
  • Result Qualifiers describe the specific results associated with the topic variable in a Findings dataset. They answer the question raised by the topic variable. Result Qualifiers are --ORRES, --STRESC, and --STRESN.
  • Synonym Qualifiers specify an alternative name for a particular variable in an observation. Examples include --MODIFY and --DECOD, which are equivalent terms for a --TRT or --TERM Topic variable, and --TEST for --TESTCD.
  • Record Qualifiers define additional attributes of the observation record as a whole (rather than describing a particular variable within a record). Examples include --REASND, AESLIFE, and all other SAE flag variables in the AE domain; AGE, SEX, and RACE in the DM domain; and --REASND, --POS, --LOC, --SPEC, and --NAM in a Findings domain
  • Variable Qualifiers are used to further modify or describe a specific variable within an observation and are only meaningful in the context of the variable they qualify. Examples include --ORRESU, --ORNRHI, and --ORNRLO, all of which are Variable Qualifiers of --ORRES; and --DOSU, which is a Variable Qualifier of --DOSE.

For example, in the observation, "Subject 101 had mild nausea starting on Study Day 6", the Topic variable value is the term for the adverse event, "NAUSEA". The Identifier variable is the subject identifier, "101". The Timing variable is the study day of the start of the event, which captures the information, "starting on Study Day 6", while an example of a Record Qualifier is the severity, the value for which is "MILD". Additional Timing and Qualifier variables could be included to provide the necessary detail to adequately describe an observation.

Most of the data collected in a study is about the subjects who are enrolled in the study. Sometimes, however, data is collected about other persons (Associated Persons, APs) who can be associated with the study, a particular study subject, or a device used in the study. Associated Persons may or may not have a familial relationship to a study subject.


Observations about study subjects are normally collected for all subjects in a series of domains. A domain is defined as a collection of logically related observations with a common topic. The logic of the relationship may pertain to the scientific subject matter of the data or to its role in the trial. Each domain dataset is distinguished by a unique, two-character code that should be used consistently throughout the submission. This code, which is stored in the SDTM variable named DOMAIN, is used in four ways: as the dataset name, the value of the DOMAIN variable in that dataset, as a prefix for most variable names in that dataset, and as a value in the RDOMAIN variable in relationship tables.

All datasets are structured as flat files with rows representing observations and columns representing variables. Each dataset is described by metadata definitions that provide information about the variables used in the dataset. The metadata are described in a data definition document named "define" that is submitted with the data to regulatory authorities. See the Define-XML Specification, available at www.CDISC.org/define-xml. Define-XML specifies variable metadata attributes such as: name, label, data type, etc.

The SDTM describes the name, label, role, and type for the standard variables. Note that the SDTM type specified in this document is either character or numeric as these are the only types supported by SAS version 5 transport files. The Define-XML provides more descriptive data types (e.g. integer, float, date, datetime). Please see the Define-XML specification for information about how to represent SDTM types using Define-XML data types.

When creating submissions, a sponsor may drop certain variables (those defined as permissible in the implementation guide) from the dataset and the corresponding descriptions from the Define-XML, i.e. the applicable "ItemRef" must be removed from the "ItemGroupDef" representing the dataset, as long as no data were collected for these variables. New sponsor defined variables must not be added, and existing variables must not be renamed or modified for novel usage. Sponsors should consult the appropriate implementation guide, which specifically describe which variables are required, expected, or permissible to use in specific domains based on the general observation classes.

The General Observation Classes

The majority of observations collected during a study can be divided among three general observation classes: Interventions, Events, or Findings:

  • The Interventions class, described in Table 2.2.1, captures investigational, therapeutic and other treatments that are administered to the subject (with some actual or expected physiological effect) either as specified by the study protocol (e.g., "exposure"), coincident with the study assessment period (e.g., "concomitant medications"), or other substances self-administered by the subject (such as alcohol, tobacco, or caffeine).
  • The Events class, described in Table 2.2.2, captures planned protocol milestones such as randomization and study completion, and occurrences, conditions, or incidents independent of planned study evaluations occurring during the trial (e.g., adverse events) or prior to the trial (e.g., medical history).
  • The Findings class, described in Table 2.2.3, captures the observations resulting from planned evaluations to address specific tests or questions such as laboratory tests, ECG testing, and questions listed on questionnaires. The Findings class also includes a sub-type "Findings About" which is used to record findings related to observations in the Interventions or Events class.

Datasets based on any of the general observation classes share a set of common Identifier and Timing variables. The set of Identifier variables used is described in Table 2.2.4. The set of Timing variables that should be used for all three general observation classes is included in Table 2.2.5. As a general rule, any valid Identifier or Timing variable is permissible for use in any submission dataset based on a general observation class.

In the tables in this section, the presence of two hyphens before the variable name (e.g., --TRT) is used to indicate the required use of a prefix based on the two-character domain code. The domain code is used as a variable prefix to minimize the risk of difficulty when merging/joining domains for reporting purposes.

In addition to the three general observation classes, a submission will generally include a set of other special-purpose datasets of specific standardized structures to represent additional important information. Examples include the following:

The SDTM is the foundation for many implementations. Examples include the SDTM Implementation Guide for Human Clinical Trials and the SEND (Standard for the Exchange of Nonclinical Data) Implementation Guide. Not all variables described in the tables in this document (SDTM tables) are appropriate for all implementations. Please refer to the implementation guides for specific information on any restrictions.

The Interventions Observations Class

Table 2.2.1:Interventions — Topic and Qualifier Variables — One Record per Constant-Dosing Interval or Intervention Episode

Variable Name

Variable Label

Type

Role

Description

--TRT

Name of Treatment

Char

Topic

The topic for the intervention observation, usually the verbatim name of the treatment, drug, medicine, or therapy given during the dosing interval for the observation.

 

Variable Name

Variable Label

Type

Role

Description

1

--MODIFY

Modified Treatment Name

Char

Synonym Qualifier of --TRT

If the value for --TRT is modified for coding purposes, then the modified text is placed here.

2

--DECOD

Standardized Treatment Name

Char

Synonym Qualifier of --TRT

Standardized or dictionary-derived name of the topic variable, --TRT, or the modified topic variable (--MODIFY), if applicable. Equivalent to the generic drug name in WHO Drug, or a term in SNOMED, ICD9, or other published or sponsor-defined dictionaries.

3

--MOOD

Mood

Char

Record Qualifier

Mode or condition of the record (e.g., SCHEDULED, PERFORMED).

4

--CAT

Category

Char

Grouping Qualifier

Used to define a category of topic-variable values.

5

--SCAT

Subcategory

Char

Grouping Qualifier

Used to define a further categorization of --CAT values.

6

--PRESP

Pre-specified

Char

Variable Qualifier of --TRT

Used when a specific intervention is pre-specified on a CRF. Values should be "Y" or null.

7

--OCCUR

Occurrence

Char

Record Qualifier

Used to record whether a pre-specified intervention occurred when information about the occurrence of a specific intervention is solicited.

8

--STAT

Completion Status

Char

Record Qualifier

Used to indicate when a question about the occurrence of a pre-specified intervention was not answered. Should be null or have a value of NOT DONE.

9

--REASND

Reason Not Done

Char

Record Qualifier

Reason not done. Used in conjunction with --STAT when value is NOT DONE.

10

--INDC

Indication

Char

Record Qualifier

Denotes the indication for the intervention (e.g., why the therapy was taken or administered).

11

--CLAS

Class

Char

Variable Qualifier of --TRT

Class for a medication or treatment, often obtained from a coding dictionary.

12

--CLASCD

Class Code

Char

Variable Qualifier of --TRT

Used to represent code for --CLAS.

13

--DOSE

Dose

Num

Record Qualifier

Amount of --TRT given. Not populated when --DOSTXT is populated.

14

--DOSTXT

Dose Description

Char

Record Qualifier

Dosing information collected in text form. Examples: <1 per day, 200-400. Not populated when --DOSE is populated.

15

--DOSU

Dose Units

Char

Variable Qualifier of --DOSE, --DOSTXT or --DOSTOT

Units for --DOSE, --DOSTOT, or --DOSTXT (Examples: ng, mg, mg/kg).

16

--DOSFRM

Dose Form

Char

Variable Qualifier of --DOSE, --DOSTXT or --DOSTOT

Dose form for the treatment. Examples: TABLET, CAPSULE.

17

--DOSFRQ

Dosing Frequency per Interval

Char

Variable Qualifier of --DOSE, --DOSTXT or --DOSTOT

Usually expressed as the number of doses given per a specific interval. Examples: Q2H, QD, PRN.

18

--DOSTOT

Total Daily Dose

Num

Record Qualifier

Total daily dose of --TRT using the units in --DOSU. Used when dosing is collected as Total Daily Dose.

19

--DOSRGM

Intended Dose Regimen

Char

Variable Qualifier of --DOSE, --DOSTXT or --DOSTOT

Text description of the (intended) schedule or regimen for the Intervention. Example: TWO WEEKS ON, TWO WEEKS OFF.

20

--ROUTE

Route of Administration

Char

Variable Qualifier of --TRT

Route of administration for the intervention. Examples: ORAL, INTRAVENOUS.

21

--LOT

Lot Number

Char

Record Qualifier

Lot number for the intervention described in --TRT.

22

--LOC

Location of Dose Administration

Char

Record Qualifier

Anatomical location of an intervention, such as an injection site. Example: ARM for an injection.

23

--LAT

Laterality

Char

Variable Qualifier of --LOC

Qualifier for anatomical location further detailing laterality of intervention administration. Examples: RIGHT, LEFT, BILATERAL

24

--DIR

Directionality

Char

Variable Qualifier of --LOC

Qualifier for anatomical location further detailing directionality of intervention administration. Examples: ANTERIOR, LOWER, PROXIMAL

25

--PORTOT

Portion or Totality

Char

Variable Qualifier of --LOC

Qualifier for anatomical location further detailing the distribution, which means arrangement of, apportioning of the intervention administration. Examples: ENTIRE, SINGLE, SEGMENT, MANY.

26

--FAST

Fasting Status

Char

Record Qualifier

Indicator used to identify fasting status. Valid values include Y, N, U or null if not relevant.

27

--PSTRG

Pharmaceutical Strength

Num

Variable Qualifier

Amount of an active ingredient expressed quantitatively per dosage unit, per unit of volume, or per unit of weight, according to the pharmaceutical dose form. Example: 50 mg/TABLET, 300 mg/L

28

--PSTRGU

Pharmaceutical Strength Units

Char

Variable Qualifier

Unit for --PSTRG. Example: mg/TABLET, mg/mL

29

--TRTV

Treatment Vehicle

Char

Record Qualifier

Vehicle for administration of treatment, such as a liquid in which the treatment drug is dissolved. Example: SALINE.

30

--VAMT

Treatment Vehicle Amount

Num

Record Qualifier

Amount of the prepared product (treatment + vehicle) administered or given. Note: should not be diluent amount alone.

31

--VAMTU

Treatment Vehicle Amount Units

Char

Variable Qualifier of --VAMT

Units for the prepared product (treatment + vehicle). Examples: mL, mg.

32

--ADJ

Reason for Dose Adjustment

Char

Record Qualifier

Describes reason or explanation of why a dose is adjusted. Examples ADVERSE EVENT, INSUFFICIENT RESPONSE, NON-MEDICAL REASON.

33

--USCHFL
 

Unscheduled Flag

Char

Record Qualifier

Indicates whether the timing of a performed test or observation was unscheduled. If a test or observation was performed based upon a schedule defined in the protocol, this flag should be null. Expected values are Y or null. Not to be used with human clinical trials. This variable would not be needed when information on planned assessments is provided, such as when the Trial Visits (TV) and Subject Visits (SV) domains are used.

The Events Observation Class

Table 2.2.2: Events — Topic and Qualifier Variables — One Record per Event

Variable Name

Variable Label

Type

Role

Description

--TERM

Reported Term

Char

Topic

Topic variable for an event observation, which is the verbatim or pre-specified name of the event.

 

Variable Name

Variable Label

Type

Role

Description

1

--MODIFY

Modified Reported Term

Char

Synonym Qualifier of --TERM

If the value for --TERM is modified for coding purposes, then the modified text is placed here.

2

--LLT

Lowest Level Term

Char

Variable Qualifier of --TERM

MedDRA Lowest Level Term.

3

--LLTCD

Lowest Level Term Code

Num

Variable Qualifier of --LLT

MedDRA Lowest Level Term code.

4

--DECOD

Dictionary-Derived Term

Char

Synonym Qualifier of --TERM

Dictionary or sponsor-defined derived text description of the topic variable, --TERM, or the modified topic variable (--MODIFY), if applicable. Equivalent to the Preferred Term (PT in MedDRA).

5

--PTCD

Preferred Term Code

Num

Variable Qualifier of --DECOD

MedDRA Preferred Term code.

6

--HLT

High Level Term

Char

Variable Qualifier of --TERM

MedDRA High Level Term from the primary path.

7

--HLTCD

High Level Term Code

Num

Variable Qualifier of --HLT

MedDRA High Level Term code from the primary path.

8

--HLGT

High Level Group Term

Char

Variable Qualifier of --TERM

MedDRA High Level Group Term from the primary path.

9

--HLGTCD

High Level Group Term Code

Num

Variable Qualifier of --HLGT

MedDRA High Level Group Term code from the primary path.

10

--CAT

Category

Char

Grouping Qualifier

Used to define a category of topic-variable values.

11

--SCAT

Subcategory

Char

Grouping Qualifier

Used to define a further categorization of --CAT values.

12

--PRESP

Pre-specified

Char

Variable Qualifier of --TERM

Used to indicate whether the event described by --TERM was pre-specified on a CRF. Value is Y for pre-specified events, null for spontaneously reported events.

13

--OCCUR

Occurrence

Char

Record Qualifier

Used to record whether a pre-specified event occurred when information about the occurrence of a specific event is solicited.

14

--STAT

Completion Status

Char

Record Qualifier

Used to indicate when a question about the occurrence of a pre-specified event was not answered. Should be null or have a value of NOT DONE.

15

--REASND

Reason Not Done

Char

Record Qualifier

Reason not done. Used in conjunction with --STAT when its value is NOT DONE.

16

--BODSYS

Body System or Organ Class

Char

Record Qualifier

Body system or system organ class assigned for analysis from a standard hierarchy (e.g. MedDRA) associated with an event. Example: GASTROINTESTINAL DISORDERS.

17

--BDSYCD

Body System or Organ Class Code

Num

Variable Qualifier of --BODSYS

MedDRA System Organ Class code corresponding to --BODSYS assigned for analysis.

18

--SOC

Primary System Organ Class

Char

Variable Qualifier of --TERM

MedDRA primary System Organ Class associated with the event.

19

--SOCCD

Primary System Organ Class Code

Num

Variable Qualifier of --SOC

MedDRA primary System Organ Class code.

20

--LOC

Location of Event

Char

Record Qualifier

Describes anatomical location relevant for the event. Example: ARM for skin rash.

21

--LAT

Laterality

Char

Variable Qualifier of --LOC

Qualifier for anatomical location further detailing laterality. Examples: RIGHT, LEFT, BILATERAL

22

--DIR

Directionality

Char

Variable Qualifier of --LOC

Qualifier for anatomical location further detailing directionality. Examples: ANTERIOR, LOWER, PROXIMAL

23

--PORTOT

Portion or Totality

Char

Variable Qualifier of --LOC

Qualifier for anatomical location further detailing the distribution, which means arrangement of, apportioning of. Examples: ENTIRE, SINGLE, SEGMENT, MANY.

24

--PARTY

Accountable Party

Char

Record Qualifier

Party accountable for the transferable object (e.g. device, specimen) as a result of the activity performed in the associated --TERM variable. The party could be an individual (e.g., subject), an organization (e.g., sponsor), or a location that is a proxy for an individual or organization (e.g., site). It is usually a somewhat general term that is further identified in the --PRTYID variable.

25

--PRTYID

Identification of Accountable Party

Char

Record Qualifier

Identification of the specific party accountable for the transferable object (e.g. device, specimen) after the action in --TERM is taken. Used in conjunction with --PARTY.

26

--SEV

Severity/Intensity

Char

Record Qualifier

The severity or intensity of the event. Examples: MILD, MODERATE, SEVERE.

27

--SER

Serious Event

Char

Record Qualifier

Is this is a serious event? Valid values are "Y" and "N".

28

--ACN

Action Taken with Study Treatment

Char

Record Qualifier

Describes changes made to the study treatment as a result of the event. Examples: DOSE INCREASED, DOSE NOT CHANGED.

29

--ACNOTH

Other Action Taken

Char

Record Qualifier

Describes other actions taken as a result of the event that are unrelated to dose adjustments of study treatment.

30

--ACNDEV

Action Taken with Device

Char

Record Qualifier

Action taken with respect to a device in a study, which may or may not be the device under study

31

--REL

Causality

Char

Record Qualifier

Records the investigator's opinion as to the causality of the event to the treatment. ICH E2A and E2B examples include NOT RELATED, UNLIKELY RELATED, POSSIBLY RELATED, RELATED.

32

--RELNST

Relationship to Non-Study Treatment

Char

Record Qualifier

An opinion as to whether the event may have been due to a treatment other than study drug. Example: "MORE LIKELY RELATED TO ASPIRIN USE."

33

--PATT

Pattern of Event

Char

Record Qualifier

Used to indicate the pattern of the event over time. Examples: INTERMITTENT, CONTINUOUS, SINGLE EVENT.

34

--OUT

Outcome of Event

Char

Record Qualifier

Description of the outcome of an event. Examples: RECOVERED/RESOLVED, FATAL.

35

--SCAN

Involves Cancer

Char

Record Qualifier

Was the event associated with the development of cancer? Valid values are "Y" and "N".

36

--SCONG

Congenital Anomaly or Birth Defect

Char

Record Qualifier

Was the event associated with congenital anomaly or birth defect? Valid values are "Y" and "N".

37

--SDISAB

Persist or Signif Disability/Incapacity

Char

Record Qualifier

Did the event result in persistent or significant disability/incapacity? Valid values are "Y" and "N".

38

--SDTH

Results in Death

Char

Record Qualifier

Did the event result in death? Valid values are "Y" and "N".

39

--SHOSP

Requires or Prolongs Hospitalization

Char

Record Qualifier

Did the event require or prolong hospitalization? Valid values are "Y" and "N".

40

--SLIFE

Is Life Threatening

Char

Record Qualifier

Was the event life threatening? Valid values are "Y" and "N".

41

--SOD

Occurred with Overdose

Char

Record Qualifier

Did the event occur with an overdose? Valid values are "Y" and "N".

42

--SMIE

Other Medically Important Serious Event

Char

Record Qualifier

Do additional categories for seriousness apply? Valid values are "Y" and "N".

43

--CONTRT

Concomitant or Additional Trtmnt Given

Char

Record Qualifier

Was another treatment given because of the occurrence of the event? Valid values are "Y" and "N".

44

--TOX

Toxicity

Char

Variable Qualifier of --TOXGR

Description of toxicity quantified by --TOXGR such as NCI CTCAE Short Name. Examples: HYPERCALCEMIA, HYPOCALCEMIA. Sponsor should specify which scale and version is used in the Sponsor Comments column of the Define-XML document.

45

--TOXGR

Toxicity Grade

Char

Record Qualifier

Records toxicity grade using a standard toxicity scale (such as the NCI CTCAE). Sponsor should specify which scale and version is used in the Sponsor Comments column of the Define-XML document.

46

--USCHFL

Unscheduled Flag

Char

Record Qualifier

Indicates whether the timing of a performed test or observation was unscheduled. If a test or observation was performed based upon a schedule defined in the protocol, this flag should be null. Expected values are Y or null. Not to be used with human clinical trials. This variable would not be needed when information on planned assessments is provided, such as when the Trial Visits (TV) and Subject Visits (SV) domains are used.

The Findings Observation Class

Table 2.2.3: Findings — Topic and Qualifier Variables — One Record per Finding

Variable Name

Variable Label

Type

Role

Description

--TESTCD

Short Name of Measurement, Test or Examination

Char

Topic

Short character value for --TEST used as a column name when converting a dataset from a vertical format to a horizontal format. The short value can be up to 8 characters. Examples: PLAT, SYSBP, RRMIN, EYEEXAM.

 

Variable Name

Variable Label

Type

Role

Description

1

--TEST

Name of Measurement, Test or Examination

Char

Synonym Qualifier of --TESTCD

Long name For --TESTCD. Examples: Platelet, Systolic Blood Pressure, Summary (Min) RR Duration, Eye Examination.

2

--MODIFY

Modified Term

Char

Synonym Qualifier of --ORRES

If the value of --ORRES is modified for coding purposes, then the modified text is placed here.

3

--TSTDTL

Measurement, Test or Examination Detail

Char

Variable Qualifier of --TESTCD and --TEST

Further description of --TESTCD and --TEST. Example: "The percentage of cells with +1 intensity of staining" when MITEST = Thyroid Transcription Factor 1.

4

--CAT

Category

Char

Grouping Qualifier

Used to define a category of topic-variable values. Examples: HEMATOLOGY, URINALYSIS, CHEMISTRY, HAMILTON DEPRESSION SCALE, SF36, EGFR MUTATION ANALYSIS.

5

--SCAT

Subcategory

Char

Grouping Qualifier

Used to define a further categorization of --CAT values. Example: WBC DIFFERENTIAL.

6

--POS

Position of Subject During Observation

Char

Record Qualifier

Position of the subject during a measurement or examination. Examples: SUPINE, STANDING, SITTING.

7

--BODSYS

Body System or Organ Class

Char

Record Qualifier

Body System or Organ Class that is involved for a finding from the standard hierarchy for dictionary-coded results. Example: MedDRA SOC.

8

--ORRES

Result or Finding in Original Units

Char

Result Qualifier

Result of the measurement or finding as originally received or collected. Examples: 120, <1, POS.

9

--ORRESU

Original Units

Char

Variable Qualifier of --ORRES

Unit for --ORRES. Examples: in, LB, kg/L.

10

--ORNRLO

Normal Range Lower Limit-Original Units

Char

Variable Qualifier of --ORRES

Lower end of normal range or reference range for results stored in --ORRES.

11

--ORNRHI

Normal Range Upper Limit-Original Units

Char

Variable Qualifier of --ORRES

Upper end of normal range or reference range for results stored in --ORRES.

12

--ORREF

Reference Result in Original Units

Char

Variable Qualifier of --ORRES

Reference value for the result or finding as originally received or collected. --ORREF uses the same units as --ORRES, if applicable. Examples: value from predicted normal value in spirometry tests.

13

--STRESC

Result or Finding in Standard Format

Char

Result Qualifier

Contains the result value for all findings, copied or derived from --ORRES in a standard format or in standard units. --STRESC should store all results or findings in character format; if results are numeric, they should also be stored in numeric format in --STRESN. For example, if various tests have results "NONE", "NEG", and "NEGATIVE" in --ORRES and these results effectively have the same meaning, they could be represented in standard format in --STRESC as "NEGATIVE".

14

--STRESN

Numeric Result/Finding in Standard Units

Num

Result Qualifier

Used for continuous or numeric results or findings in standard format; copied in numeric format from --STRESC. --STRESN should store all numeric test results or findings.

15

--STRESU

Standard Units

Char

Variable Qualifier of --STRESC and --STRESN

Standardized units used for --STRESC and --STRESN. Example: mol/L.

16

--STNRLO

Normal Range Lower Limit-Standard Units

Num

Variable Qualifier of --STRESC and --STRESN

Lower end of normal range or reference range for standardized results (e.g., --STRESC, --STRESN) represented in standardized units (-STRESU).

17

--STNRHI

Normal Range Upper Limit-Standard Units

Num

Variable Qualifier of --STRESC and --STRESN

Upper end of normal range or reference range for standardized results (e.g., --STRESC, --STRESN) represented in standardized units (-STRESU).

18

--STNRC

Normal Range for Character Results

Char

Variable Qualifier of --STRESC

Normal range or reference range for results stored in --STRESC that are character in ordinal or categorical scale. Example: Negative to Trace.

19

--STREFC

Reference Result in Standard Format

Char

Variable Qualifier of --STRESC

Reference value for the result or finding copied or derived from --ORREF in a standard format.

20

--STREFN

Numeric Reference Result in Std Units

Num

Variable Qualifier of --STRESN

Reference value for continuous or numeric results or findings in standard format or in standard units. --STREFN uses the same units as --STRESN, if applicable.

21

--NRIND

Normal/Reference Range Indicator

Char

Variable Qualifier of --ORRES

Used to indicate the value is outside the normal range or reference range. May be defined by --ORNRLO and --ORNRHI or other objective criteria. Examples: Y, N; HIGH, LOW; NORMAL; ABNORMAL.

22

--RESCAT

Result Category

Char

Variable Qualifier of --ORRES

Used to categorize the result of a finding. Example: MALIGNANT or BENIGN for tumor findings. RESISTANCE VARIANT for genetic variation.

23

--CHRON

Chronicity of Finding

Char

Variable Qualifier of --STRESC

Characterization of the duration of a biological process resulting in a particular finding. Examples: ACUTE, CHRONIC, SUBACUTE.

24

--DISTR

Distribution Pattern of Finding

Char

Variable Qualifier of --STRESC

Description of the distribution pattern of a finding within the examined area. Examples: FOCAL, MULTIFOCAL, DIFFUSE, FOCAL MULTIFOCAL.

25--RESLOCResult Location of FindingCharResult Qualifier

NEW Location where the result was observed (as opposed to the location specified for examination). May have a higher degree of specificity than the value in --LOC.

26

--STAT

Completion Status

Char

Record Qualifier

Used to indicate that a question was not asked or a test was not done, or a test was attempted but did not generate a result. Should be null or have a value of NOT DONE.

27

--REASND

Reason Not Done

Char

Record Qualifier

Reason not done. Used in conjunction with --STAT when value is NOT DONE.

28

--XFN

External File Path

Char

Record Qualifier

Filename for an external file, such as one for an ECG waveform or a medical image.

29

--NAM

Laboratory/Vendor Name

Char

Record Qualifier

Name or identifier of the vendor (e.g., laboratory) that provided the test results.

30

--LOINC

LOINC Code

Char

Synonym Qualifier of --TESTCD

Logical Observation Identifiers Names and Codes (LOINC) code for the topic variable such as a lab test.

31

--SPEC

Specimen Material Type

Char

Record Qualifier

Defines the type of specimen used for a measurement. Examples: SERUM, PLASMA, URINE, DNA, RNA.

32

--ANTREG

Anatomical Region

Char

Variable Qualifier of --SPEC

Defines the specific anatomical or biological region of a tissue, organ specimen or the region from which the specimen is obtained, as defined in the protocol, such as a section or part of what is described in the --SPEC variable. Examples: CORTEX, MEDULLA, MUCOSA

33

--SPCCND

Specimen Condition

Char

Record Qualifier

Defines the condition of the specimen. Example: CLOUDY.

34

--SPCUFL

Specimen Usability for the Test

Char

Record Qualifier

Describes the usability of the specimen for the test. The value will be N if the specimen is not usable, and null if the specimen is usable.

35

--LOC

Location Used for the Measurement

Char

Record Qualifier

Anatomical location of the subject relevant to the collection of the measurement. Examples: RECTAL for temperature, ARM for blood pressure.

36

--LAT

Laterality

Char

Variable Qualifier of --LOC

Qualifier for anatomical location or specimen further detailing laterality. Examples: RIGHT, LEFT, BILATERAL

37

--DIR

Directionality

Char

Variable Qualifier of --LOC

Qualifier for anatomical location or specimen further detailing directionality. Examples: ANTERIOR, LOWER, PROXIMAL

38

--PORTOT

Portion or Totality

Char

Variable Qualifier of --LOC

Qualifier for anatomical location or specimen further detailing the distribution, which means arrangement of, apportioning of. . Examples: ENTIRE, SINGLE, SEGMENT, MANY.

39

--METHOD

Method of Test or Examination

Char

Record Qualifier

Method of the test or examination. Examples: EIA (Enzyme Immunoassay), ELECTROPHORESIS, DIPSTICK

40

--RUNID

Run ID

Char

Record Qualifier

A unique identifier for a particular run of a test on a particular batch of samples.

41

--ANMETH

Analysis Method

Char

Record Qualifier

Analysis method applied to obtain a summarized result. Analysis method describes the method of secondary processing applied to a complex observation result (e.g. an image or a genetic sequence).

42

--LEAD

Lead Identified to Collect Measurements

Char

Record Qualifier

Lead or leads identified to capture the measurement for a test from an instrument. Examples: LEAD I, LEAD V2, LEAD CM5.

43

--CSTATE

Consciousness State

Char

Record Qualifier

The consciousness state of the subject at the time of measurement. Examples: CONSCIOUS, SEMI-CONSCIOUS, UNCONSCIOUS

44

--LOBXFL

Last Observation Before Exposure Flag

Char

Record Qualifier

Operationally-derived indicator used to identify the last non-missing value prior to RFXSTDTC. Should be Y or null.

45

--BLFL

Baseline Flag

Char

Record Qualifier

Indicator used to identify a baseline value. Should be Y or null.

46

--FAST

Fasting Status

Char

Record Qualifier

Indicator used to identify fasting status. Valid values include Y, N, U or null if not relevant.

47

--DRVFL

Derived Flag

Char

Record Qualifier

Used to indicate a derived record (e.g., a record that represents the average of other records such as a computed baseline). Should be Y or null.

48

--EVAL

Evaluator

Char

Record Qualifier

Role of the person who provided the evaluation. Used only for results that are subjective (e.g., assigned by a person or a group). Examples: ADJUDICATION COMMITTEE, INDEPENDENT ASSESSOR, RADIOLOGIST.

49

--EVALID

Evaluator Identifier

Char

Variable Qualifier of --EVAL

Used to distinguish multiple evaluators with the same role recorded in --EVAL. Examples: RADIOLOGIST1, RADIOLOGIST2.

50

--ACPTFL

Accepted Record Flag

Char

Record Qualifier

In cases where more than one assessor provides an evaluation of a result or response, this flag identifies the record that is considered to be the accepted evaluation. Expected values can include Y, N or null. This is not intended to be an analysis flag to indicate acceptability for a given analysis

51

--TOX

Toxicity

Char

Variable Qualifier of --TOXGR

Description of toxicity quantified by --TOXGR such as NCI CTCAE Short Name. Examples: HYPERCALCEMIA, HYPOCALCEMIA. Sponsor should specify which scale and version is used in the Sponsor Comments column of the Define-XML document.

52

--TOXGR

Toxicity Grade

Char

Record Qualifier

Records toxicity grade using a standard toxicity scale (such as the NCI CTCAE). Sponsor should specify which scale and version is used in the Sponsor Comments column of the Define data definition document. Example: 2.

53

--SEV

Severity

Char

Record Qualifier

Describes the severity or intensity of a particular finding. Examples: MILD, MODERATE, SEVERE.

54

--DTHREL

Relationship to Death

Char

Record Qualifier

Describes the relationship of a particular finding to the death of a subject. Examples: Y, N or U. Not to be used with human clinical trials.

55

--LLOQ

Lower Limit of Quantitation

Num

Variable Qualifier of --STRESC and --STRESN

Indicates the lower limit of quantitation for an assay. Units will be those used for --STRESU.

56

--ULOQ

Upper Limit of Quantitation

Num

Variable Qualifier of --STRESC and --STRESN

Indicates the upper limit of quantitation for an assay. Units will be those used for --STRESU.

57

--EXCLFL

Exclude from Statistics

Char

Record Qualifier

Indicates whether the values in the result variables for this record should be excluded from summary statistical calculations such as Mean, Standard Deviation, and Count (and others). Expected to be Y or null. --EXCLFL should not be used when --STAT is NOT DONE. Not to be used with human clinical trials.

58

--REASEX

Reason for Exclusion from Statistics

Char

Record Qualifier

Reason excluded from statistics. Used in conjunction with --EXCLFL when its value is Y. Not to be used with human clinical trials.

59

--USCHFL

Unscheduled Flag

Char

Record Qualifier

Indicates whether the timing of a performed test or observation was unscheduled. If a test or observation was performed based upon a schedule defined in the protocol, this flag should be null. Expected values are Y or null. Not to be used with human clinical trials. This variable would not be needed when information on planned assessments is provided, such as when the Trial Visits (TV) and Subject Visits (SV) domains are used.

60

--REPNUM

Repetition Number

Num

Record Qualifier

The instance number of a test that is repeated within a given timeframe for the same test. The level of granularity can vary, e.g., within a time point or within a visit. For example, multiple measurements of blood pressure or multiple analyses of a sample.

Findings About Events or Interventions

Findings About Events or Interventions utilizes the Findings General Observation Class variables with the addition of the --OBJ variable as described in the following table. Note, the --OBJ variable must only be used in Findings About Events or Interventions.

Table 2.2.3.1: Findings About — Additional Qualifiers

Variable Name

Variable Label

Type

Role

Description

--OBJ

Object of the Observation

Char

Record Qualifier

Used in domains modeled as Findings About Events or Findings About Interventions. Describes the event or intervention whose property is being measured in --TESTCD/--TEST. Example: an event of vomiting which has findings, where --OBJ = "VOMIT" and the volume of VOMIT is being measured where --TESTCD = "VOLUME".

Identifiers for All Classes

All of the following identifier variables are available for use in any domain based on one of the three general observation classes. STUDYID, DOMAIN and --SEQ are required in all domains based on one of the three general observation classes. Each general class domain must also include at least one of the following subject identifiers: USUBJID, APID, SPDEVID, or POOLID.

All identifier variables are allowed for all implementation guides.

Table 2.2.4: All Observation Classes — Identifiers

 

Variable Name

Variable Label

Type

Description

1

STUDYID

Study Identifier

Char

Unique identifier for a study.

2

DOMAIN

Domain Abbreviation

Char

Two-character abbreviation for the domain most relevant to the observation. The Domain abbreviation is also used as a prefix for variables to ensure uniqueness when datasets are merged.

3

USUBJID

Unique Subject Identifier

Char

Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product.

4

APID

Associated Persons Identifier

Char

Identifier for a single associated person, a group of associated persons, or a pool of associated persons. If APID identifies a pool, POOLDEF records must exist for each associated person. (See Section 4.1.3 for Pool Definition Dataset and Section 5 for Associated Persons Data).

5

POOLID

Pool Identifier

Char

An identifier used to identify a result from a group of subjects that is not assignable to a specific subject.

6

SPDEVID

Sponsor Device Identifier

Char

Sponsor-defined identifier for a device.

7NHOIDNon-Host Organism IdentifierCharSponsor-defined identifier for a non-host organism. This variable should be populated with an intuitive name based on the identity of the non-host organism as reported by the lab (Example: "A/California/7/2009 (H1N1)").
8

FETUSID

Fetus Identifier

Char

Identifier used to identify a fetus from a maternal subject for prenatal evaluations. FETUSID uniquely identifies a fetus within a subject.

9

FOCID

Focus of Study-Specific Interest

Char

Identification of a focus of study-specific interest on or within a subject or specimen as called out in the protocol for which a measurement, test, or examination was performed, such as a drug application site, e.g., "Injection site 1", "Biopsy site 1", "Treated site 1", or a more specific focus, e.g., "OD" (right eye) or "Upper left quadrant of the back". The value in this variable should have inherent semantic meaning.

10

--SEQ

Sequence Number

Num

Sequence number to ensure uniqueness of records within a dataset for a subject (or within a parameter, in the case of the Trial Summary domain). May be any valid number (including decimals) and does not have to start at 1.

11

--GRPID

Group ID

Char

Optional group identifier, used to link together a block of related records within a subject in a domain. Also used to link together a block of related records in the Trial Summary dataset (Section 3.3).

12

--REFID

Reference ID

Char

Optional internal or external identifier such as lab specimen ID, or UUID for an ECG waveform or a medical image.

13

--RECID

Invariant Record Identifier

Char

Identifier for a record that is unique within a domain for a study and that remains invariant through subsequent versions of the dataset, even if the content of the record is modified. When a record is deleted, this value must not be reused to identify another record in either the current or future versions of the domain.

14

--SPID

Sponsor-Defined Identifier

Char

Sponsor-defined identifier. Example: pre-printed line identifier on a Concomitant Medications page.

15

--LNKID

Link ID

Char

Identifier used to link related records across domains. This may be a one-to-one or a one-to-many relationship. For Example: A single tumor may have multiple measurements/assessments performed at each study visit.

16

--LNKGRP

Link Group ID

Char

Identifier used to link related records across domains. This will usually be a many-to-one relationship. For example: Multiple tumor measurements/assessments will contribute to a single response to therapy determination record.

Timing Variables for All Classes

All of the following timing variables are available for use in any domain based on one of the three general observation classes except where restricted in implementation guide standard-domain-model assumptions.

All timing variables are allowed for all implementation guides.

Table 2.2.5: All Observation Classes — Timing Variables

 

Variable Name

Variable Label

Type

Format

Description

1

VISITNUM

Visit Number

Num

 

Clinical encounter number. Numeric version of VISIT, used for sorting.

2

VISIT

Visit Name

Char

 

Protocol-defined description of a clinical encounter.

3

VISITDY

Planned Study Day of Visit

Num

 

Planned study day of VISIT. Should be an integer.

4

TAETORD

Planned Order of Element within Arm

Num

 

Number that gives the planned order of the Element within the Arm (see Trial Arms Section 3.1.2).

5

EPOCH

Epoch

Char

 

Epoch associated with the start date/time of the observation, or the date/time of collection if start date/time is not collected (see Trial Arms Section 3.1.2).

6RPHASERepro PhaseChar 

NEW Reproductive Phase with which the Reproductive Stage of the Reproductive Path is associated. Defined in Trial Paths domain. The RPHASE variable is Required when any Reproductive Phase Day variable is used. Not to be used with human clinical trials.

7

RPPLDY

 

Planned Repro Phase Day of Observation
Num 

NEW The planned day within the Reproductive Phase on which the observation was scheduled to occur. Expressed as an integer. Not to be used with human clinical trials.

8

RPPLSTDY

 

Planned Repro Phase Day of Obs Start

Num 

NEW The planned day within the Reproductive Phase of the start of the observation. Expressed as an integer. Not to be used with human clinical trials.

9

RPPLENDY

 

Planned Repro Phase Day of Obs End

Num 
NEW The planned day within the Reproductive Phase of the end of the observation. Expressed as an integer. Not to be used with human clinical trials.
10

--DTC

Date/Time of Collection

Char

ISO 8601

Collection date and time of an observation.

11

--STDTC

Start Date/Time of Observation

Char

ISO 8601

Start date/time of an observation.

12

--ENDTC

End Date/Time of Observation

Char

ISO 8601

End date/time of the observation.

13

--DY

Study Day of Visit/Collection/Exam

Num

 

Actual study day of visit/collection/exam expressed in integer days relative to the sponsor-defined RFSTDTC in Demographics.

14

--STDY

Study Day of Start of Observation

Num

 

Actual study day of start of observation expressed in integer days relative to the sponsor-defined RFSTDTC in Demographics.

15

--ENDY

Study Day of End of Observation

Num

 

Actual study day of end of observation expressed in integer days relative to the sponsor-defined RFSTDTC in Demographics.

16

--NOMDY

Nominal Study Day for Tabulations

Num

 

The nominal study day used by data-collection and reporting systems for grouping records for observations that may be scheduled to occur on different days into a single study day (such as for output on a tabulation report). Not to be used with human clinical trials.

17

--NOMLBL

Label for Nominal Study Day

Char

 

A label for a given value of --NOMDY, within a domain, as presented in the study report. Not to be used with human clinical trials.

18

--RPDY 

 

Actual Repro Phase Day of Observation
Num 

NEW The actual day within the Reproductive Phase on which the observation occurred. Expressed as an integer. Not to be used with human clinical trials.

19
--RPSTDY 
Actual Repro Phase Day of Obs Start
Num 
NEW The actual day within the Reproductive Phase of the start of the observation. Expressed as an integer. Not to be used with human clinical trials.
20--RPENDY
Actual Repro Phase Day of Obs End
Num 
NEW The actual day within the Reproductive Phase of the end of the observation. Expressed as an integer. Not to be used with human clinical trials.
21

--DUR

Duration

Char

ISO 8601

Collected duration of an event, intervention, or finding. Used only if collected on the CRF and not derived.

22

--TPT

Planned Time Point Name

Char

 

Text description of time when a measurement or observation should be taken as defined in the protocol. This may be represented as an elapsed time relative to a fixed reference point, such as time of last dose. See --TPTNUM and --TPTREF.

23

--TPTNUM

Planned Time Point Number

Num

 

Numeric version of planned time point used in sorting.

24

--ELTM

Planned Elapsed Time from Time Point Ref

Char

ISO 8601

Planned Elapsed time relative to a planned fixed reference (--TPTREF) such as "Previous Dose" or "Previous Meal". This variable is useful where there are repetitive measures. Not a clock time or a date/time variable, but an interval.

25

--TPTREF

Time Point Reference

Char

 

Description of the fixed reference point referred to by --ELTM, --TPTNUM, and --TPT. Examples: PREVIOUS DOSE, PREVIOUS MEAL.

26

--RFTDTC

Date/Time of Reference Time Point

Char

ISO 8601

Date/time for a fixed reference time point defined by --TPTREF.

27

--STRF

Start Relative to Reference Period

Char

 

Identifies the start of the observation as being before, during, or after the sponsor-defined reference period. The sponsor-defined reference period is a continuous period of time defined by a discrete starting point and a discrete ending point represented by RFSTDTC and RFENDTC in Demographics.

28

--ENRF

End Relative to Reference Period

Char

 

Identifies the end of the observation as being before, during or after the sponsor-defined reference period. The sponsor-defined reference period is a continuous period of time defined by a discrete starting point and a discrete ending point represented by RFSTDTC and RFENDTC in Demographics.

29

--EVLINT

Evaluation Interval

Char

ISO 8601

Duration of interval associated with an observation such as a finding --TESTCD. Example: -P2M to represent a period of the past 2 months as the evaluation interval for a question from a questionnaire such as SF-36.

30

--EVINTX

Evaluation Interval Text

Char

 

Evaluation interval associated with an observation, where the interval is not able to be represented in ISO 8601 format. Examples: LIFETIME, LAST NIGHT, RECENTLY, OVER THE LAST FEW WEEKS.

31

--STRTPT

Start Relative to Reference Time Point

Char

 

Identifies the start of the observation as being before or after the sponsor-defined reference time point defined by variable --STTPT.

32

--STTPT

Start Reference Time Point

Char

 

Description or date/time in ISO 8601 or other character format of the sponsor-defined reference point referred to by --STRTPT. Examples: "2003-12-15" or "VISIT 1".

33

--ENRTPT

End Relative to Reference Time Point

Char

 

Identifies the end of the observation as being before or after the sponsor-defined reference time point defined by variable --ENTPT.

34

--ENTPT

End Reference Time Point

Char

 

Description or date/time in ISO 8601 or other character format of the sponsor-defined reference point referred to by --ENRTPT. Examples: "2003-12-25" or "VISIT 2".

35

MIDS

Disease Milestone Instance Name

Char

 

The name of a specific instance of a Disease Milestone Type (MIDSTYPE) described in the Trial Disease Milestones dataset (see Trial Disease Milestones Section 3.5). This should be unique within a subject. Used only in conjunction with RELMIDS and MIDSDTC.

36

RELMIDS

Temporal Relation to Milestone Instance

Char

 

The temporal relationship of the observation to the Disease Milestone Instance Name in MIDS. Examples: IMMEDIATELY BEFORE, AT TIME OF, AFTER.

37

MIDSDTC

Disease Milestone Instance Date/Time

Char

ISO 8601

The start date/time of the Disease Milestone Instance Name in MIDS.

38

--STINT

Planned Start of Assessment Interval

Char

ISO 8601

The start of a planned evaluation or assessment interval relative to the Time Point Reference (--TPTREF).

39

--ENINT

Planned End of Assessment Interval

Char

ISO 8601

The end of a planned evaluation or assessment interval relative to the Time Point Reference (--TPTREF).

40

--DETECT

Time in Days to Detection

Num

 

The number of days from the start of dosing to the earliest detection of a condition or pathogen.  Not to be used with human clinical trials.

Demographics

Each study must include one standardized set of observations in a specific structure; this is the Demographics domain described in Table 2.2.6. Demographics is the parent domain for all other observations for subjects, and should be identified with the domain code of "DM". The Demographics domain describes the essential characteristics of the study subjects, and is used by reviewers for selecting subsets of subjects for analysis. The Demographics domain, as with other datasets, includes Identifiers, a Topic variable, Timing variables, and Qualifiers. Since DM has a fixed structure, only certain variables may be added as appropriate. See the implementation guides for guidance on which additional variables can be added to this domain.

Table 2.2.6: Subject Demographics Domain Variables

 

Variable Name

Variable Label

Type

Format

Role

Description

1

STUDYID

Study Identifier

Char

 

Identifier

Unique identifier for a study.

2

DOMAIN

Domain Abbreviation

Char

 

Identifier

Two-character abbreviation for the domain which must be DM.

3

USUBJID

Unique Subject Identifier

Char

 

Identifier

Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product.

4

SUBJID

Subject Identifier for the Study

Char

 

Topic

Subject identifier, which must be unique within the study. Often the ID of the subject as recorded on a CRF.

5

RFSTDTC

Subject Reference Start Date/Time

Char

ISO 8601

Qualifier

Reference Start Date/time for the subject. Usually equivalent to date/time when subject was first exposed to study treatment. Required for all randomized subjects; will be null for all subjects who did not meet the milestone the date requires, such as screen failures or unassigned subjects.

6

RFENDTC

Subject Reference End Date/Time

Char

ISO 8601

Qualifier

Reference End Date/time for the subject. Usually equivalent to the date/time when subject was determined to have ended the trial, and often equivalent to date/time of last exposure to study treatment. Required for all randomized subjects; null for screen failures or unassigned subjects.

7

RFXSTDTC

Date/Time of First Study Treatment

Char

ISO 8601

Qualifier

First date/time of exposure to any protocol-specified treatment or therapy for the subject.

8

RFXENDTC

Date/Time of Last Study Treatment

Char

ISO 8601

Qualifier

Last date/time of exposure to any protocol-specified treatment or therapy for the subject.

9

RFICDTC

Date/Time of Informed Consent

Char

ISO 8601

Qualifier

Date/time of informed consent.

10

RFPENDTC

Date/Time of End of Participation

Char

ISO 8601

Qualifier

Date/time when subject ended participation or follow-up in a trial. Should correspond to the last known date of contact.

11

DTHDTC

Date/Time of Death

Char

ISO 8601

Qualifier

Date/time of death for any subject who died, in ISO 8601 format. Should represent the date/time that is captured in the clinical-trial database.

12

DTHFL

Subject Death Flag

Char

 

Qualifier

A value of 'Y' indicates the subject died. Should be Y or null. Should be populated even when the death date is unknown.

13

SITEID

Study Site Identifier

Char

 

Qualifier

Unique identifier for a site within a study.

14

INVID

Investigator Identifier

Char

 

Qualifier

An identifier to describe the Investigator for the study. May be used in addition to the SITEID. Not needed if SITEID is equivalent to INVID.

15

INVNAM

Investigator Name

Char

 

Qualifier

Name of the investigator for a site.

16

BRTHDTC

Date/Time of Birth

Char

ISO 8601

Qualifier

Date/time of birth of the subject.

17

AGE

Age

Num

 

Qualifier

Age expressed in AGEU. May be derived as (RFSTDTC-BRTHDTC), but BRTHDTC may not be available in all cases (due to subject privacy concerns).

18

AGETXT

Age Text

Char

number-number

Qualifier

The age of the subject at study start, as planned, expressed as a range. If an age integer value is available, then populate the age variable instead. Either the AGE or AGETXT variable should be populated, but not both.

19

AGEU

Age Units

Char

 

Qualifier

Units associated with AGE or AGETXT.

20

SEX

Sex

Char

 

Qualifier

Sex of the subject.

21

RACE

Race

Char

 

Qualifier

Race of the subject. Sponsors should refer to "Collection of Race and Ethnicity Data in Clinical Trials" (FDA, October 2016) for guidance regarding the collection of race (http://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm126396.pdf)

22

ETHNIC

Ethnicity

Char

 

Qualifier

The ethnicity of the subject. Sponsors should refer to "Collection of Race and Ethnicity Data in Clinical Trials" (FDA, October 2016) for guidance regarding the collection of ethnicity (http://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm126396.pdf)

23

SPECIES

Species

Char

 

Qualifier

Used to identify the common species name of the subject (i.e., test system) under study (e.g., MOUSE, RAT, DOG, MONKEY).

24

STRAIN

Strain/Substrain

Char

 

Qualifier

Used to identify the vendor-supplied strain/substrain designation for the subject (i.e., test system) under study. When applicable, it combines the root strain, substrain, and associated genetic modifications, as supplied by the vendor (e.g., C57BL/6, A/J, B6.129-Pparg<tm2Rev>/J, FISCHER 344, SPRAGUE DAWLEY IGS, WISTAR Kyoto, BEAGLE, CYNOMOLGUS, CHIMPANZEE).

25

SBSTRAIN

Strain/Substrain Details

Char

 

Qualifier

Free-text field that allows the sponsor to enter additional details regarding the subject (i.e. test system) under study, such as a description of a specific genetic alteration.

26

ARMCD

Planned Arm Code

Char

 

Qualifier

Short name for the Arm to which the subject was assigned, limited to 20 characters.

27

ARM

Description of Planned Arm

Char

 

Qualifier

Name of the Arm to which the subject was assigned.

28

ACTARMCD

Actual Arm Code

Char

 

Qualifier

Short name for the actual Arm in which the subject participated during the trial, limited to 20 characters.

29

ACTARM

Description of Actual Arm

Char

 

Qualifier

Description of the actual Arm in which the subject participated during the trial.

30

SETCD

Set Code

Char

 

Qualifier

Short name of a specific Trial Set (see Table 3.1.4), as defined by the sponsor. Maximum of 8 characters. This represents the code for the Trial Set for which parameters are being submitted.

31RPATHCDPlanned Repro Path CodeChar Qualifier

NEW Short name for the planned Repro Path to which the subject was assigned. Limited to 20 characters. Not to be used with human clinical trials.

32

COUNTRY

Country

Char

 

Qualifier

Country of the investigational site at which the subject participated in the trial in ISO 3166 three-character format.

33

DMDTC

Date/Time of Collection

Char

ISO 8601

Timing

Date/time of collection of the demographic information.

34

DMDY

Study Day of Collection

Num

 

Timing

Study day of collection measured as integer days. Algorithm for calculations must be relative to the sponsor-defined RFSTDTC in Demographics.

Comments

Comments are collected during the conduct of many studies. These are normally supplied by a principal investigator, but might also be collected from other sources such as central reviewers. When collected, comments should be submitted in a single Comments domain, which is defined in Table 2.2.7.

Please see Implementation Guide for further guidance regarding use of additional Identifier and Timing variables.

Table 2.2.7: Comments Domain Variables

 

Variable Name

Variable Label

Type

Format

Role

Description

1

STUDYID

Study Identifier

Char

 

Identifier

Unique identifier for a study.

2

DOMAIN

Domain Abbreviation

Char

 

Identifier

Two-character abbreviation for the domain which must be CO.

3

RDOMAIN

Related Domain Abbreviation

Char

 

Record Qualifier

Domain Abbreviation of the parent record(s). Null for records collected on general comments or additional information CRF page.

4

USUBJID

Unique Subject Identifier

Char

 

Identifier

Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product.

5

POOLID

Pool Identifier

Char

 

Identifier

Used to identify a result for pooled subjects that is not assignable to any one individual within the pool.

6

COSEQ

Sequence Number

Num

 

Identifier

Sequence number to ensure uniqueness within a domain. Should be assigned to be in a consistent chronological order.

7

IDVAR

Identifying Variable

Char

 

Record Qualifier

Identifying variable in the parent dataset that identifies the record(s) to which the comment applies. Examples AESEQ or CMGRPID. Used only when individual comments are related to domain records. Null for comments collected on separate CRFs.

8

IDVARVAL

Identifying Variable Value

Char

 

Record Qualifier

Value of identifying variable of the parent record(s). Null for comments collected on separate CRFs.

9

COREF

Comment Reference

Char

 

Record Qualifier

Sponsor-defined reference associated with the comment. May be the CRF page number (e.g. 650), or a module name (e.g. DEMOG), or a combination of information that identifies the reference (e.g. 650-VITALS-VISIT 2).

10

COVAL

Comment

Char

 

Topic

The text of the comment. Text over 200 characters can be added to additional columns COVAL1-COVALn.

11

COEVAL

Evaluator

Char

 

Record Qualifier

Used to describe the originator of the comment. Example: CENTRAL REVIEWER.

12

CODTC

Date/Time of Comment

Char

ISO 8601

Timing

Date/time of comment on dedicated comment form, if collected. Should be null if this is a child record of another domain or if comment date was not collected.

Subject Elements

The Subject Elements dataset describes the actual order of Elements that were traversed by the subject, together with the start date/time and end date/time for each Element. The planned Elements are described in Trial Elements (Section 3.1.1) of the Trial Design Model. Because actual data does not always follow the plan, the model allows for descriptions of an unplanned Element for subjects.

Please see the specific implementation guides for further guidance regarding use of additional Identifier and Timing variables.

Table 2.2.8: Subject Elements — One Record per Actual Element per Subject

 

Variable Name

Variable Label

Type

Format

Role

Description

1

STUDYID

Study Identifier

Char

 

Identifier

Unique identifier for a study.

2

DOMAIN

Domain Abbreviation

Char

 

Identifier

Two-character abbreviation for the domain which must be SE.

3

USUBJID

Unique Subject Identifier

Char

 

Identifier

Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product.

4

SESEQ

Sequence Number

Num

 

Identifier

Sequence number to ensure uniqueness within dataset. Should be assigned to be in a consistent chronological order.

5

ETCD

Element Code

Char

 

Topic

ETCD (the companion to ELEMENT) is limited to 8 characters and does not have special character restrictions. These values should be short for ease of use in programming, but it is not expected that ETCD will need to serve as a variable name.

6

ELEMENT

Description of Element

Char

 

Qualifier

The name of the Element. If ETCD has a value of "UNPLAN" then ELEMENT should be null.

7

SESTDTC

Start Date/Time of Element

Char

ISO 8601

Timing

Start date/time for an Element for each subject.

8

SEENDTC

End Date/Time of Element

Char

ISO 8601

Timing

End date/time of an Element for each subject.

9

TAETORD

Planned Order of Element within Arm

Num

 

Timing

Number that gives the planned order of the Element within the subject's assigned ARM.

10

EPOCH

Epoch

Char

 

Timing

Epoch associated with the Element in the planned sequence of Elements for the ARM to which the subject was assigned

11

SEUPDES

Description of Unplanned Element

Char

 

Optional Qualifier*

Description of what happened to the subject during an unplanned Element. Used only if ETCD has the value of "UNPLAN".

* Optional additional qualifier variables are placed at the end because they are seldom used.

Subject Visits

The Subject Visits dataset describes the actual start and end date/time for each visit of each individual subject. The planned trial visits are described in Trial Visits (Section 3.1.3) of the Trial Design Model. Because actual data does not always follow the plan, the model allows for descriptions of unplanned visits for subjects.

Please see the Implementation Guides for further guidance regarding use of additional Identifier and Timing variables.

Table 2.2.9: Subject Visits — One Record per Subject Visit, per Subject

 

Variable Name

Variable Label

Type

Format

Role

Description

1

STUDYID

Study Identifier

Char

 

Identifier

Unique identifier for a study.

2

DOMAIN

Domain Abbreviation

Char

 

Identifier

Two-character abbreviation for the domain, which must be SV.

3

USUBJID

Unique Subject Identifier

Char

 

Identifier

Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product.

4

VISITNUM

Visit Number

Num

 

Topic

Clinical encounter number. (Decimal numbering may be useful for inserting unplanned visits.) Numeric version of VISIT, used for sorting.

5

VISIT

Visit Name

Char

 

Timing

Protocol-defined description of clinical encounter or description of unplanned visit. May be used in addition to VISITNUM and/or VISITDY as a text description of the clinical encounter.

6

VISITDY

Planned Study Day of Visit

Num

 

Timing

Planned study day of the start of the visit based upon RFSTDTC in Demographics.

7

SVSTDTC

Start Date/Time of Visit

Char

ISO 8601

Timing

Start date/time for a subject's visit.

8

SVENDTC

End Date/Time of Visit

Char

ISO 8601

Timing

End date/time of a subject's visit.

9

SVSTDY

Study Day of Start of Visit

Num

 

Timing

Study day of start of visit relative to the sponsor-defined RFSTDTC.

10

SVENDY

Study Day of End of Visit

Num

 

Timing

Study day of end of visit relative to the sponsor-defined RFSTDTC.

11

SVUPDES

Description of Unplanned Visit

Char

 

Optional Qualifier*

Description of what happened to the subject during an unplanned visit. Null for protocol-defined visits.

* Optional additional Qualifier variables are placed at the end because they are seldom used.

Subject Disease Milestones

The Subject Disease Milestones domain is designed to record the timing, for each subject, of Disease Milestones that have been defined in the Trial Disease Milestones (TM) dataset in Section 3.5.

Table 2.2.10: Subject Disease Milestones — One Record per Disease Milestone, per Subject

 

Variable
Name

Variable Label

Type

Format

Role

Description

1

STUDYID

Study Identifier

Char

 

Identifier

Unique identifier for a study.

2

DOMAIN

Domain

Char

 

Identifier

Two-character abbreviation for the domain, which must be SM.

3

USUBJID

Unique Subject Identifier

Char

 

Identifier

Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product.

4

SMSEQ

Sequence Number

Num

 

Identifier

Sequence Number given to ensure uniqueness of subject records. Should be assigned to be consistent with chronological order.

5

MIDS

Disease Milestone Instance Name

Char

 

Topic

Name of the specific Disease Milestone. For types of Disease Milestones that can occur multiple times, the name will end with a sequence number. Example: HYPO 1.

6

MIDSTYPE

Disease Milestone Type

Char

 

Qualifier

The type of Disease Milestone. Example: HYPOGLYCEMIC EVENT.

7

SMSTDTC

Start Date/Time of Milestone

Char

ISO 8601

Timing

Start date/time of Milestone Instance, if Milestone is an intervention or event, or date of Milestone if Milestone is a finding.

8

SMENDTC

End Date/Time of Milestone

Char

ISO 8601

Timing

End date/time of Disease Milestone Instance.

9

SMSTDY

Study Day of Start of Milestone

Num

 

Timing

Study day of start of Disease Milestone Instance, relative to the sponsor-defined RFSTDTC.

10

SMENDY

Study Day of End of Milestone

Num

 

Timing

Study day of end of Disease Milestone Instance, relative to the sponsor-defined RFSTDTC.

Subject Repro Stages

The Subject Repro Stages dataset (not for use with human clinical trials) describes the actual order of Repro Stages that were experienced by the subject, together with the start date/time and end date/time for each Repro Stage. The planned Repro Stages are described in Trial Repro Stages (Table 3.1.5) of the Trial Design Model. Because actual data does not always follow the plan, the model allows for descriptions of an unplanned Repro Stage for subjects.

Table 2.2.11: Subject Repro Stages — One Record per Actual Repro Stage per Subject

NEW 
 

Variable Name

Variable Label

Type

Format

Role

Description

1

STUDYID

Study Identifier

Char

 

Identifier

Unique identifier for a study.

2

DOMAIN

Domain Abbreviation

Char

 

Identifier

Two-character abbreviation for the domain, which must be SJ.

3

USUBJID

Unique Subject Identifier

Char

 

Identifier

Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product.

4

SJSEQ

Sequence Number

Num

 

Identifier

Sequence number to ensure uniqueness within dataset. Should be assigned to be in a consistent chronological order.

5

RSTGCD

Repro Stage Code

Char

 

Topic

Short name of the Repro Stage used for programming and sorting. Maximum 8 characters.

6

RSTAGE

Description of Repro Stage

Char

 

Qualifier

The name of the Repro Stage. If RSTGCD has a value of “UNPLAN” then RSTAGE should be null.

7

SJSTDTC

Start Date/Time of Repro Stage

Char

ISO 8601

Timing

Start date/time for a Repro Stage for each subject.

8

SJENDTC

End Date/Time of Repro Stage

Char

ISO 8601

Timing

End date/time for a Repro Stage for each subject.

9RPHASERepro PhaseChar TimingName of the reproductive phase with which this Repro Stage of the Repro Path is associated.
10

SEUPDES

Description of Unplanned Element

Char

 

Optional Qualifier*

Description of what happened to the subject during an unplanned Repro Stage. Used only if RSTGCD has the value of "UNPLAN".

* Optional additional qualifier variables are placed at the end because they are seldom used.


Domain-Specific Variables for the General Observation Class

The concept of domain-specific variables was first introduced in SDTM v1.5. These variables are for use only in a specific domain and will be identified in the appropriate implementation guide. The variable names include the specific domain prefix. Table 2.2.12 lists the proposed domain-specific variables.

Table 2.2.12: Domain-Specific Variables for General Observation Class Domains

Observation Class

Domain

Variable Name

Variable Label

Type

Role

Description

Position

InterventionsEXEXMETHODMethod of AdministrationCharRecord QualifierMethod of administration of the treatment. Not to be used with human clinical trials.

After EXLOC

Findings

EG

EGBEATNO

ECG Beat Number

Num

Variable Qualifier of EGORRES

A sequence number that identifies the beat within an ECG.

After EGPOS

FindingsICICIMPLBL Implantation Site LabelCharRecord QualifierLabel or identifier that describes the location or position of a fetal implantation site in the uterus (or uterine horn) when classifying implantations during a uterine examination in a reproductive toxicology study.After ICSTRESC

The Trial Design Model

The Trial Design Model defines a standard structure for representing the planned sequence of events and the treatment plan for the trial. The model provides a standard way to define the treatment groups and planned visits and assessments that will be experienced by trial subjects.

The model is built upon the concepts of Elements, Arms, Epochs, and Visits. The variables corresponding to these concepts are used in many domains. The implementation guides define specific details and examples for Trial Design.

Planned Elements, Arms, Visits, Sets, Repro Stages, and Repro Paths

Under the model, planned information is presented in a series of four tables:

  • The Trial Elements dataset (TE) (Table 3.1.1) describes the Element code (unique for each Element), the Element description, and the rules for starting and ending an Element. A rule could be expressed as pseudo code or as executable code for determining transitions from one Element to another.
  • The Trial Arms dataset (TA) (Table 3.1.2) describes each planned Arm in the trial. An Arm is described as an ordered sequence of Elements, and the same Element may occur more than once in a given Arm. In order to accommodate complex Trial Designs, this dataset allows for rules for branching from one Element to another when a choice is available, and a rule for transitions to allow a subject to skip ahead to another Element rather than proceed linearly.
  • The Trial Visits dataset (TV) (Table 3.1.3) describes the planned order and number of visits in the study. In the case when visits vary for each Arm, there would be a separate record per Visit per Arm. It describes the allowable or planned values for VISIT, VISITNUM and VISITDY in the trial (which are subsequently used as Timing Variables for the collected study data), and rules for starting and ending each visit. In most blinded trials, the timing of visits is the same for all subjects in all Arms.
  • The Trial Sets dataset (TX) (Table 3.1.4) allows the submission of detailed information about planned groups of subjects that result as a combination of experimental factors of interest for a study (including experimental parameters, inherent characteristics, and sponsor-defined attributes). A Set may be a planned subdivision of a Trial Arm, or may consist of one or more Trial Arms. These datasets are essential to determine whether data comparisons are feasible across different studies.
  • The Trial Repro Stages domain (TT) (Table 3.1.5) describes the unique Repro Stages in a study, with Repro Stage code, description, and rules for start and end. Note: Not for use with human clinical trials.
  • The Trial Repro Paths domain (TP) (Table 3.1.6) describes each planned Repro Path in a Repro study, with the ordered sequence of Repro Stages that comprise each Repro Path, as well as specification of Repro Phase and reference start day applicable to the Repro Stage within the Repro Path. Note: Not for use with human clinical trials.

Trial Elements

Table 3.1.1: Trial Elements — One Record per Trial Element

 

Variable Name

Variable Label

Type

Format

Description

1

STUDYID

Study Identifier

Char

 

Unique identifier for a study.

2

DOMAIN

Domain Abbreviation

Char

 

Two-character abbreviation for the domain, which must be TE.

3

ETCD

Element Code

Char

 

ETCD (the companion to ELEMENT) is limited to 8 characters and does not have special character restrictions. These values should be short for ease of use in programming, but it is not expected that ETCD will need to serve as a variable name.

4

ELEMENT

Description of Element

Char

 

The name of the Element.

5

TESTRL

Rule for Start of Element

Char

 

Expresses the rule for beginning the Element.

6

TEENRL

Rule for End of Element

Char

 

Expresses the rule for ending the Element. Either TEENRL or TEDUR must be present for each Element.

7

TEDUR

Planned Duration of Element

Char

ISO 8601

Planned Duration of Element. Used when the rule for ending the Element is applied after a fixed duration.

Trial Arms

Table 3.1.2: Trial Arms — One Record per Planned Element per Arm

 

Variable Name

Variable Label

Type

Description

1

STUDYID

Study Identifier

Char

Unique identifier for a study.

2

DOMAIN

Domain Abbreviation

Char

Two-character abbreviation for the domain, which must be TA.

3

ARMCD

Planned Arm Code

Char

ARMCD is limited to 20 characters and does not have special character restrictions.

4

ARM

Description of Planned Arm

Char

Name given to Arm or treatment group.

5

TAETORD

Planned Order of Element within Arm

Num

Number that gives the order of the Element within the Arm.

6

ETCD

Element Code

Char

ETCD (the companion to ELEMENT) is limited to 8 characters and does not have special character restrictions. These values should be short for ease of use in programming, but it is not expected that ETCD will need to serve as a variable name.

7

ELEMENT

Description of Element

Char

The name of the Element.

8

TABRANCH

Branch

Char

Condition subjects meet, at a "branch" in the Trial Design at the end of this Element, to be included in this Arm. Example: Randomization to DRUG X.

9

TATRANS

Transition Rule

Char

If the trial design allows a subject to transition to an Element other than the next Element in sequence, then the conditions for transitioning to those other Elements, and the alternative Element sequences, are specified in this rule (e.g., Responders go to washout).

10

EPOCH

Epoch

Char

Name of the Trial Epoch with which this Element of the Arm is associated.

 Note: The same Element may occur more than once within an Arm, but each occurrence would have a different value for TAETORD and EPOCH, and may have different values for TABRANCH and TATRANS.

Trial Visits

Table 3.1.3: Trial Visits — One Record per Planned Trial Visit

 

Variable Name

Variable Label

Type

Description

1

STUDYID

Study Identifier

Char

Unique identifier for a study.

2

DOMAIN

Domain Abbreviation

Char

Two-character abbreviation for the domain, which must be TV.

3

VISITNUM

Visit Number

Num

Clinical encounter number. Numeric version of VISIT can be used for sorting.

4

VISIT

Visit Name

Char

Protocol-defined description of the clinical encounter. May be used in addition to VISITNUM and/or VISITDY as a text description of the clinical encounter.

5

VISITDY

Planned Study Day of Visit

Num

Planned study day of VISIT. Due to its sequential nature, can be used for sorting.

6

ARMCD

Planned Arm Code

Char

ARMCD is limited to 20 characters and does not have special character restrictions. If the timing of visits for a trial does not depend on which ARM a subject is in, then ARMCD should be null.

7

ARM

Description of Planned Arm

Char

Name given to Arm or treatment group.

8

TVSTRL

Visit Start Rule

Char

Rule describing when the visit starts, in relation to the sequence of Elements.

9

TVENRL

Visit End Rule

Char

Rule describing when the visit ends, in relation to the sequence of Elements.

Trial Sets

Table 3.1.4: Trial Sets — One Record per Trial Set Parameter

 

Variable Name

Variable Label

Type

Description

1

STUDYID

Study Identifier

Char

Unique identifier for a study.

2

DOMAIN

Domain Abbreviation

Char

Two-character abbreviation for the domain, which must be TX.

3

SETCD

Set Code

Char

Short name of a specific Trial Set, as defined by the sponsor. Maximum 8 characters. This represents the Trial Set for which parameters are being submitted.

4

SET

Set Description

Char

Long description of a specific Trial Set, as defined by the sponsor.

5

TXSEQ

Sequence Number

Num

Unique number for this record within this dataset.

6

TXPARMCD

Trial Set Parameter Short Name

Char

Short character value for the Trial Set parameter described in TXPARM. Maximum 8 characters.

7

TXPARM

Trial Set Parameter

Char

Term for the Trial Set parameter. Maximum 40 characters.

8

TXVAL

Trial Set Parameter Value

Char

Value of the Trial Set parameter (e.g., Fed ad libitum or Restricted Feeding when TXPARM is FEEDREG). Some parameters may be subject to controlled terminology.

Trial Repro Stages

Table 3.1.5: Trial Repro Stages — One Record per Planned Repro Stage

NEW 
 

Variable Name

Variable Label

Type

Format

Description

1

STUDYID

Study Identifier

Char

 

Unique identifier for a study.

2

DOMAIN

Domain Abbreviation

Char

 

Two-character abbreviation for the domain, which must be TT.

3

RSTGCD

Repro Stage Code

Char

 

Short name of the Repro Stage used for programming and sorting. Maximum 8 characters.

4

RSTAGE

Description of Repro Stage

Char

 

The name of the Repro Stage.

5

TTSTRL

Rule for Start of Repro Stage

Char

 

Expresses the rule for beginning the Repro Stage.

6

TTENRL

Rule for End of Repro Stage

Char

 

Expresses the rule for ending the Repro Stage. Either TTENRL or TTDUR must be present for each Repro Stage.

7

TTDUR

Planned Duration of Repro Stage

Char

ISO 8601

Planned Duration of Repro Stage. Used when the rule for ending the Repro Stage is applied after a fixed duration.

Trial Repro Paths

Table 3.1.6: Trial Repro Paths — One Record per Planned Repro Stage per Repro Path

NEW 
 

Variable Name

Variable Label

Type

Description

1

STUDYID

Study Identifier

Char

Unique identifier for a study.

2

DOMAIN

Domain Abbreviation

Char

Two-character abbreviation for the domain, which must be TP.

3

RPATHCD

Planned Repro Path Code

Char

Short name for the planned Repro Path. Limited to 20 characters. Should be populated in Demographics when Repro Paths have been defined in this domain.

4

RPATH

Description of Planned Repro Path

Char

Name of the planned Repro Path.

5

TPSTGORD

Order of Repro Stage within Repro Path

Num

Number that gives the planned order of the Repro Stage within the Repro Path.

6

RSTGCD

Repro Stage Code

Char

Short name of the Repro Stage used for programming and sorting. Maximum 8 characters. The values of RSTGCD used in the Trial Paths dataset must match values for the same Repro Stage in the Trial Stages dataset.

7

RSTAGE

Description of Repro Stage

Char

The name of the Repro Stage. The same Repro Stage may occur more than once within a Repro Path.

8

TPBRANCH

Branch

Char

Conditions subjects meet, occurring at the end of a Repro Stage, which cause a Repro Path to branch off from another Repro Path. 

9

RPHASE

Repro Phase

Char

Name of the reproductive phase with which this Repro Stage of the Repro Path is associated.

10

RPRFDY

Repro Phase Start Reference Day

Num

Sponsor Protocol-defined first day of Repro Phase. Should be 0 or 1.

Trial Inclusion Exclusion Criteria

The Trial Inclusion Exclusion Domain (TI) contains one record for each of the inclusion and exclusion criteria for the trial.

Table 3.2: Trial Inclusion/Exclusion — One Record per Trial Inclusion or Exclusion Criterion

 

Variable Name

Variable Label

Type

Description

1

STUDYID

Study Identifier

Char

Unique identifier for a study.

2

DOMAIN

Domain Abbreviation

Char

Two-character abbreviation for the domain, which must be TI.

3

IETESTCD

Inclusion/Exclusion Criterion Short Name

Char

Short name IETEST. It can be used as a column name when converting a dataset from a vertical to a horizontal format. The value in IETESTCD cannot be longer than 8 characters, nor can it start with a number (e.g., "1TEST"). IETESTCD cannot contain characters other than letters, numbers, or underscores. The name "IE" prefix is used to ensure consistency with the IE domain

4

IETEST

Inclusion/Exclusion Criterion

Char

Full text of the inclusion or exclusion criterion. The prefix "IE" is used to ensure consistency with the IE domain.

5

IECAT

Inclusion/Exclusion Category

Char

Used for categorization of the Inclusion/Exclusion Criterion: INCLUSION, EXCLUSION.

6

IESCAT

Inclusion/Exclusion Subcategory

Char

A further categorization of the exception criterion. Can be used to distinguish criteria for a sub-study or for to categorize as a major or minor exceptions. Examples: MAJOR, MINOR.

7

TIRL

Inclusion/Exclusion Criterion Rule

Char

Rule that expresses the criterion in computer-executable form.

8

TIVERS

Protocol Criteria Versions

Char

The number of this version of the Inclusion/Exclusion criteria. May be omitted if there is only one version.

Trial Summary Information

The Trial Summary Information Domain (TS) contains one record for each trial summary characteristic. Trial Summary is used to record basic information about the trial, such as trial phase, protocol title and design objectives.

Table 3.3: Trial Summary — One Record per Trial Summary Parameter

 Variable NameVariable LabelTypeDescription
1

STUDYID

Study Identifier

Char

Unique identifier for a study.

2

DOMAIN

Domain Abbreviation

Char

Two-character abbreviation for the domain, which must be TS.

3

TSSEQ

Sequence Number

Num

Sequence number to ensure uniqueness within the dataset.

4

TSGRPID

Group ID

Char

Used to tie together a group of related records.

5

TSPARMCD

Trial Summary Parameter Short Name

Char

TSPARMCD (the companion to TSPARM) is limited to 8 characters and does not have special character restrictions. These values should be short for ease of use in programming, but it is not expected that TSPARMCD will need to serve as variable names.
Examples: AGEMIN, AGEMAX

6

TSPARM

Trial Summary Parameter

Char

Term for the Trial Summary Parameter. The value in TSPARM cannot be longer than 40 characters. Examples Planned Minimum Age of Subjects, Planned Maximum Age of Subjects

7

TSVAL

Parameter Value

Char

Value of TSPARM. Example: "ASTHMA" when TSPARM value is "Trial Indications". If TSVAL is null; a value is required for TSVALNF. Text over 200 characters can be added to additional columns TSVAL1-TSVALn.

8

TSVALNF

Parameter Null Flavor

Char

Null flavor for the value of TSVAL describing the reason the value is null, to be populated if and only if TSVAL is null.

9

TSVALCD

Parameter Value Code

Char

Code of the term in TSVAL from Reference Terminology cited in TSVCDREF.

10

TSVCDREF

Name of the Reference Terminology

Char

The name of the reference terminology or standard format from which TSVALCD is taken. For example; CDISC, SNOMED, ISO8601.

11

TSVCDVER

Version of the Reference Terminology

Char

The version number of the Reference Terminology cited in TSVCDREF, if applicable.

Trial Disease Assessments

The TD domain provides information on the planned protocol-specified disease assessment schedule. In oncology studies, good compliance with the disease-assessment schedule is essential to reduce the risk of "assessment time bias". The TD domain makes possible an evaluation of 'assessment time bias' from SDTM-based datasets, by allowing a comparison of the planned schedule of assessments against the actual occurrence of the efficacy assessments in order to determine the degree of compliance. TD has limited utility outside oncology and indeed has limited utility within oncology studies, it was developed specifically with Response Evaluation Criteria in Solid Tumors (RECIST) in mind, and in particular, for studies with progression-free survival (PFS) endpoints where an assessment time bias analysis is appropriate.

Table 3.4: Trial Disease Assessments — One Record per Planned Constant Assessment Period

 Variable NameVariable LabelTypeFormatDescription
1

STUDYID

Study Identifier

Char

 

Unique identifier for a study.

2

DOMAIN

Domain Abbreviation

Char

 

Two-character abbreviation for the domain, which must be TD.

3

TDORDER

Sequence of Planned Assessment Schedule

Num

 

A number given to ensure ordinal sequencing of the planned assessment schedules within a trial.

4

TDANCVAR

Anchor Variable Name

Char

 

A reference to the date variable name that provides the start point from which the planned disease assessment schedule is measured. This must be referenced from the ADaM ADSL dataset e.g. ANCH1DT. Note: TDANCVAR is to contain the name of a reference date variable name.

5

TDSTOFF

Offset from the Anchor

Char

ISO 8601

A fixed offset from the date provided by the variable referenced in TDANCVAR. This is used when the timing of planned cycles does not start on the exact day referenced in the variable indicated in TDANCVAR. The value of this variable will be either zero or a positive value.

6

TDTGTPAI

Planned Assessment Interval

Char

ISO 8601

The planned interval between disease assessments.

7

TDMINPAI

Planned Assessment Interval Minimum

Char

ISO 8601

The lower limit of the allowed range for the planned interval between disease assessments.

8

TDMAXPAI

Planned Assessment Interval Maximum

Char

ISO 8601

The upper limit of the allowed range for the planned interval between disease assessments.

9

TDNUMRPT

Maximum Number of Actual Assessments

Num

 

This variable must represent the maximum number of actual assessments for the analysis that this disease assessment schedule describes. In a trial where the maximum number of assessments is not defined explicitly in the protocol (e.g. assessments occur until death) TDNUMRPT should represent the maximum number of disease assessments that support the efficacy analysis, encountered by any subject across the trial at that point in time.

 

Trial Disease Milestones

The Trial Disease Milestones domain is used to describe observations or activities expected to occur in the course of the disease under study, and whose timing is of interest for the study.

Table 3.5: Trial Disease Milestones — One record per Disease Milestone type

 Variable NameVariable LabelTypeDescription
1

STUDYID

Study Identifier

Char

Unique identifier for a study.

2

DOMAIN

Domain

Char

Two-character abbreviation for the domain, which must be TM.

3

MIDSTYPE

Disease Milestone Type

Char

The type of Disease Milestone. Example: HYPOGLYCEMIC EVENT.

4

TMDEF

Disease Milestone Definition

Char

Definition of the Disease Milestone.

5

TMRPT

Disease Milestone Repetition Indicator

Char

Indicates whether this is a Disease Milestone that can occur only once (N) or a type of Disease Milestone that can occur multiple times (Y).

Representing Relationships among Datasets and Records

There are many occasions when it is necessary or desirable to represent relationships among datasets or records. The SDTM identifies eight distinct types of relationships:

  • A relationship between a group of records for a given subject within the same dataset.
  • A relationship between independent records (usually in separate datasets) for a subject, such as a concomitant medication taken to treat an adverse event.
  • A relationship between two (or more) datasets where records of one (or more) dataset(s) are related to record(s) in another dataset (or datasets).
  • A dependent relationship where data that cannot be represented by a standard variable within a general-observation-class dataset record (or records) can be related back to that record.
  • A dependent relationship between a comment in the Comments domain and a parent record (or records) in other datasets, such as a comment recorded in association with an adverse event.
  • A relationship between a subject and a pool of subjects.
  • A relationship between a subject and associated person(s) (see Section 5.2).
  • A relationship between subjects in a study other than membership in a pool.

The implementation guides define specific details and examples for each of these relationships.

Datasets for Representing Relationships

Related Records Dataset

Table 4.1.1: RELREC Dataset

 

Variable Name

Variable Label

Type

Description

1

STUDYID

Study Identifier

Char

Study Identifier of the domain record(s).

2

RDOMAIN

Related Domain Abbreviation

Char

Two-character abbreviation for the domain of the parent record(s).

3

USUBJID

Unique Subject Identifier

Char

Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product.

4

APID

Associated Persons Identifier

Char

Identifier for a single associated person, a group of associated persons, or a pool of associated persons. If APID identifies a pool, POOLDEF records must exist for each associated person (see Section 4.1.3 for Pool Definition Dataset and Section 5 for Applying Model Fundamentals to Associated Persons).

5

POOLID

Pool Identifier

Char

Identifier used for pooling subjects to assign a single finding to multiple subjects.

6

IDVAR

Identifying Variable

Char

Name of the identifying variable in the general-observation-class dataset that identifies the related record(s). Examples include --SEQ and --GRPID.

7

IDVARVAL

Identifying Variable Value

Char

Value of identifying variable described in IDVAR. If --SEQ is the variable being used to describe this record, then the value of --SEQ would be entered here.

8

RELTYPE

Relationship Type

Char

Identifies the hierarchical level of the records in the relationship. Values should be either ONE or MANY. However, values are only necessary when identifying a relationship between datasets.

9

RELID

Relationship Identifier

Char

RELID value should be unique within the ID variable (e.g., USUBJID, APID, POOLID, SPDEVID) that is the subject of the relationship. All records with this ID variable that have the same RELID are considered "related/associated." RELID can be any value the sponsor chooses, and is only meaningful within the RELREC dataset to identify the related/associated Domain records.

Supplemental Qualifiers (SUPP--) Dataset

Table 4.1.2: SUPPQUAL Dataset

 

Variable Name

Variable Label

Type

Description

1

STUDYID

Study Identifier

Char

Study Identifier of the parent record(s).

2

RDOMAIN

Related Domain Abbreviation

Char

Two-character abbreviation for the domain of the parent record(s).

3

USUBJID

Unique Subject Identifier

Char

Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product.

4

APID

Associated Persons Identifier

Char

Identifier for a single associated person, a group of associated persons, or a pool of associated persons. If APID identifies a pool, POOLDEF records must exist for each associated person (see Section 4.1.3 for Pool Definition Dataset and Section 5 Applying Model Fundamentals to Associated Persons).

5

POOLID

Pool Identifier

Char

Identifier used for pooling subjects to assign a single finding to multiple subjects.

6

IDVAR

Identifying Variable

Char

Identifying variable in the parent dataset that identifies the related record(s). Examples: --SEQ, --GRPID.

7

IDVARVAL

Identifying Variable Value

Char

Value of identifying variable of the parent record(s).

8

QNAM

Qualifier Variable Name

Char

The short name of the Qualifier variable, which is used as a column name in a domain view with data from the parent domain. The value in QNAM cannot be longer than 8 characters, nor can it start with a number (e.g., "1TEST"). QNAM cannot contain characters other than letters, numbers, or underscores. This will often be the column name in the sponsor's operational dataset.

9

QLABEL

Qualifier Variable Label

Char

This is the long name or label associated with QNAM. The value in QLABEL cannot be longer than 40 characters. This will often be the column label in the sponsor's original dataset.

10

QVAL

Data Value

Char

Result of, response to, or value associated with QNAM. A value for this column is required; no records can be in a SUPP-- dataset with a null value for QVAL

11

QORIG

Origin

Char

Since QVAL can represent a mixture of collected (on a CRF), derived, or assigned items, QORIG is used to indicate the origin of this data. Examples include CRF, ASSIGNED, or DERIVED.

12

QEVAL

Evaluator

Char

Used only for results that are subjective (e.g., assigned by a person or a group). Should be null for records that contain objectively collected or derived data. Some examples include ADJUDICATION COMMITTEE, STATISTICIAN, DATABASE ADMINISTRATOR, CLINICAL COORDINATOR, etc.

Pool Definition Dataset

This dataset identifies individual subjects included in a pool of subjects for which a single observation record (pool level) is captured.

Table 4.1.3: POOLDEF Dataset

 

Variable Name

Variable Label

Type

Description

1

STUDYID

Study Identifier

Char

Study Identifier of the parent record(s).

2

POOLID

Pool Identifier

Char

Identifier used for pooling subjects to assign a single finding to multiple subjects.

3

USUBJID

Unique Subject Identifier

Char

Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product.

4

APID

Associated Persons Identifier

Char

Identifier for a single associated person, a group of associated persons, or a pool of associated persons.

Related Subjects Dataset

Some studies include subjects who are related to each other, and in some cases it is important to record those relationships. Studies in which pregnant women are treated and both the mother and her child(ren) are study subjects are the most common case in which relationships between subjects are collected. There are also studies of genetically based diseases where subjects who are related to each other are enrolled, and the relationships between subjects are recorded.

Table 4.1.4: RELSUB Dataset

 

Variable Name

Variable Label

Type

CDISC Notes

1

STUDYID

Study Identifier

Char

Unique identifier for a study.

2

USUBJID

Unique Subject Identifier

Char

Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product. Either USUBJID or POOLID must be populated.

3

POOLID

Pool Identifier

Char

Identifier used to identify a pool of subjects. If POOLID is entered, POOLDEF records must exist for each subject in the pool and USUBJID must be null. Either USUBJID or POOLID must be populated.

4

RSUBJID

Related Subject or Pool Identifier

Char

Identifier used to identify a related subject or pool of subjects. RSUBJID will be populated with either the USUBJID of the related subject or the POOLID of the related pool.

5

SREL

Subject Relationship

Char

Describes the relationship of the subject identified in USUBJID or the pool identified in POOLID to the subject or pool identified in RSUBJID.

Applying Model Fundamentals to Associated Persons

Creating Associated Persons Domains

Associated Persons (AP) are persons other than study subjects who can be associated with a study, a particular study subject, or a device used in the study. AP domains are created using SDTM variables, with the application of specific AP rules, including:

  • Implementers creating AP domains will follow the AP assumptions for the Identifier variables.
  • AP will be the prefix for the domain and dataset name, and will identify the dataset as AP data.
  • APID will be required in all AP datasets, and will identify records in a data warehouse as AP data.

The Study Data Tabulation Model Associate Persons Implementation Guide (SDTMIG-AP) provides implementation rules and advice. Unless an exception is described in this implementation guide, all other general assumptions about SDTM and SDTMIG variables and domains apply to AP data.

Variables Used in Associated Persons Data

Table 5.1.1: Associated Persons Data — Identifier Variables

 

Variable Name

Variable Label

Type

Description

1

APID

Associated Persons Identifier

Char

Identifier for a single associated person, a group of associated persons, or a pool of associated persons. If APID identifies a pool, POOLDEF records must exist for each associated person (see Section 4.1.3 for Pool Definition Dataset and Section 5 Applying Model Fundamentals to Associated Persons).

2

RSUBJID

Related Subject or Pool Identifier

Char

Identifier for a related subject or pool of subjects. RSUBJID may be populated with the USUBJID of the related subject or the POOLID of the related pool. 
RSUBJID will be null for data about associated persons who are related to the study but not to any study subjects.

3

RDEVID

Related Device Identifier

Char

Identifier for a related device. RDEVID will be populated with the SPDEVID of the related device.

4

SREL

Subject, Device, or Study Relationship

Char

If RSUBJID is populated, describes the relationship of the associated person(s) identified in APID to the subject or pool identified in RSUBJID. 
If RDEVID is populated, describes the relationship of the associated person(s) identified in APID to the subject or pool identified in RDEVID. 
If RSUBJID and RDEVID are null, SREL describes the relationship of the associated person(s) identified in APID to the study identified in STUDYID.

Associated Person Relationships

Some sort of a relationship is necessary between an AP and a study, a subject, or a device to justify collection of data for an AP. However, in cases where an AP has relationships to multiple subjects or devices and/or multiple relationships to a single subject or device, a single value in SREL is inadequate to describe these multiple relationships. In those cases, the value MULTIPLE should appear in SREL. If an AP has relationships with multiple subjects, MULTIPLE may also appear in RSUBJID. When other SDTM variables are populated with MULTIPLE, the multiple values are stored in Supplemental Qualifiers. However, this was found to be an indirect and cumbersome way to handle multiple relationships of an AP to subject(s). In addition, if an AP had data in multiple domains, the Supplemental Qualifier approach would require the same set of Supplemental Qualifiers to be repeated for each domain. The APRELSUB dataset, which parallels the structure of the RELSUB dataset, was created as a more efficient and simpler way to record these multiple relationships. The APRELSUB dataset is required for studies in which SREL values of MULTIPLE appear, but would not be needed if each AP has only one relationship to a study, a subject or a device.

Table 5.2: APRELSUB Dataset

 

Variable Name

Variable Label

Type

Role

Description

1

STUDYID

Study Identifier

Char

Identifier

Unique identifier for a study.

2

APID

Associated Persons Identifier

Char

Identifier

Identifier for a single associated person, a group of associated persons, or a pool of associated persons. If APID identifies a pool, POOLDEF records must exist for each associated person (see Section 4.1.3 for Pool Definition Dataset and Section 5 Applying Model Fundamentals to Associated Persons).

3

RSUBJID

Related Subject or Pool Identifier

Char

Identifier

Identifier for a related subject or pool of subjects. RSUBJID may be populated with the USUBJID of the related subject or the POOLID of the related pool.
RSUBJID will be null for data about associated persons who are related to the study but not to any study subjects.

4

RDEVID

Related Device Identifier

Char

Identifier

Identifier for a related device. RDEVID will be populated with the SPDEVID of the related device.

5

SREL

Subject, Device, or Study Relationship

Char

Record Qualifier

If RSUBJID is populated, describes the relationship of the associated person(s) identified in APID to the subject or pool identified in RSUBJID.
If RDEVID is populated, describes the relationship of the associated person(s) identified in APID to the subject or pool identified in RDEVID.
If RSUBJID and RDEVID are null, SREL describes the relationship of the associated person(s) identified in APID to the study identified in STUDYID.

Using the Model for Regulatory Submissions

The SDTM has been designed to accommodate the broadest range of human and animal study data in a standardized manner. This document describes the basic concepts and general structures of the model. Individual implementation guides have been created to provide specific recommendations for numerous domains of data commonly collected in human, animal and medical device studies, identifying which variables from a general observation class may apply. These implementation guides also describe basic assumptions and business rules, and provide numerous examples for mapping data to the standard format. Any sponsor wishing to submit data in the standard formats should first consult the implementation guides before preparing a regulatory submission based on the SDTM. The following implementation guides have been published by CDISC:

  1. The Study Data Tabulation Model Implementation Guide for Human Clinical Trials (SDTMIG)
  2. The Standard for Exchange of Non-Clinical Data Implementation Guide (SENDIG)
  3. The Study Data Tabulation Model Implementation Guide for Medical Devices (SDTMIG-MD)
  4. The Study Data Tabulation Model Associated Persons Implementation Guide (SDTMIG-AP)
  5. The Study Data Tabulation Model Pharmacogenomics/Genetics (SDTMIG-PGx)

SDTM Version History

Changes from SDTM v1.5 to SDTM v1.6

Variable, Dataset, and Section Additions

Table 2.2.3: Findings — Topic and Qualifier Variables

    • --RESLOC - Result Location of Finding

Table 2.2.5 – Timing Variables for All Classes

    • RPHASE - Repro Phase
    • RPPLDY - Planned Repro Phase Day of Observation
    • RPPLSTDY - Planned Repro Phase Day of Obs Start
    • RPPLENDY - Planned Repro Phase Day of Obs End
    • --RPDY - Actual Repro Phase Day of Observation
    • --RPSTDY - Actual Repro Phase Day of Obs Start
    • --RPENDY - Actual Repro Phase Day of Obs End

Table 2.2.6 - Demographics

    • RPATHCD - Planned Repro Path Code

Table 2.2.11: Subject Repro Stages (new table)

Table 3.1.5: Trial Repro Stages (new table)

Table 3.1.6: Trial Repro Paths (new table)

Appendices

Representations and Warranties, Limitations of Liability, and Disclaimers

CDISC Patent Disclaimers

It is possible that implementation of and compliance with this standard may require use of subject matter covered by patent rights. By publication of this standard, no position is taken with respect to the existence or validity of any claim or of any patent rights in connection therewith. CDISC, including the CDISC Board of Directors, shall not be responsible for identifying patent claims for which a license may be required in order to implement this standard or for conducting inquiries into the legal validity or scope of those patents or patent claims that are brought to its attention.

Representations and Warranties

“CDISC grants open public use of this User Guide (or Final Standards) under CDISC’s copyright.” 

Each Participant in the development of this standard shall be deemed to represent, warrant, and covenant, at the time of a Contribution by such Participant (or by its Representative), that to the best of its knowledge and ability: (a) it holds or has the right to grant all relevant licenses to any of its Contributions in all jurisdictions or territories in which it holds relevant intellectual property rights; (b) there are no limits to the Participant’s ability to make the grants, acknowledgments, and agreements herein; and (c) the Contribution does not subject any Contribution, Draft Standard, Final Standard, or implementations thereof, in whole or in part, to licensing obligations with additional restrictions or requirements inconsistent with those set forth in this Policy, or that would require any such Contribution, Final Standard, or implementation, in whole or in part, to be either: (i) disclosed or distributed in source code form; (ii) licensed for the purpose of making derivative works (other than as set forth in Section 4.2 of the CDISC Intellectual Property Policy (“the Policy”)); or (iii) distributed at no charge, except as set forth in Sections 3, 5.1, and 4.2 of the Policy. If a Participant has knowledge that a Contribution made by any Participant or any other party may subject any Contribution, Draft Standard, Final Standard, or implementation, in whole or in part, to one or more of the licensing obligations listed in Section 9.3, such Participant shall give prompt notice of the same to the CDISC President who shall promptly notify all Participants.

No Other Warranties/Disclaimers. ALL PARTICIPANTS ACKNOWLEDGE THAT, EXCEPT AS PROVIDED UNDER SECTION 9.3 OF THE CDISC INTELLECTUAL PROPERTY POLICY, ALL DRAFT STANDARDS AND FINAL STANDARDS, AND ALL CONTRIBUTIONS TO FINAL STANDARDS AND DRAFT STANDARDS, ARE PROVIDED “AS IS” WITH NO WARRANTIES WHATSOEVER, WHETHER EXPRESS, IMPLIED, STATUTORY, OR OTHERWISE, AND THE PARTICIPANTS, REPRESENTATIVES, THE CDISC PRESIDENT, THE CDISC BOARD OF DIRECTORS, AND CDISC EXPRESSLY DISCLAIM ANY WARRANTY OF MERCHANTABILITY, NONINFRINGEMENT, FITNESS FOR ANY PARTICULAR OR INTENDED PURPOSE, OR ANY OTHER WARRANTY OTHERWISE ARISING OUT OF ANY PROPOSAL, FINAL STANDARDS OR DRAFT STANDARDS, OR CONTRIBUTION.

Limitation of Liability

IN NO EVENT WILL CDISC OR ANY OF ITS CONSTITUENT PARTS (INCLUDING, BUT NOT LIMITED TO, THE CDISC BOARD OF DIRECTORS, THE CDISC PRESIDENT, CDISC STAFF, AND CDISC MEMBERS) BE LIABLE TO ANY OTHER PERSON OR ENTITY FOR ANY LOSS OF PROFITS, LOSS OF USE, DIRECT, INDIRECT, INCIDENTAL, CONSEQUENTIAL, OR SPECIAL DAMAGES, WHETHER UNDER CONTRACT, TORT, WARRANTY, OR OTHERWISE, ARISING IN ANY WAY OUT OF THIS POLICY OR ANY RELATED AGREEMENT, WHETHER OR NOT SUCH PARTY HAD ADVANCE NOTICE OF THE POSSIBILITY OF SUCH DAMAGES.

Note: The CDISC Intellectual Property Policy can be found at: http://www.cdisc.org/system/files/all/article/application/pdf/cdisc_20ip_20policy_final.pdf.