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Therapeutic Area Data Standards User Guide for Nutritional Research

Version 1.0 (Draft)

Prepared by the 
Nutrition Team

 

Notes to Readers

  • This is the draft version 1.0 of the Therapeutic Area Data Standards User Guide for Nutritional Research. It is intended for review only and is not a final version.
  • This document is based on CDASHIG v2.0 and CDASH Model v1.0, and SDTM v1.7 and SDTMIG v3.3, and SDTMIG-PGx v1.0. 

Revision History

Date

Version

2018-08-17

1.0 Draft


© 2018 Clinical Data Interchange Standards Consortium, Inc. All rights reserved. See Representations and Warranties, Limitations of Liability, and Disclaimers.

Introduction

This Therapeutic Area Data Standards User Guide for Nutritional Research (TAUG-Nutrition) was led NUT-48 - Getting issue details... STATUS by Nutrition companies under the Clinical Data Interchange Standards Consortium (CDISC) umbrella. 

The goal of the Nutrition Therapeutic Area Data Standards project is to accelerate clinical research and nutrition products development by facilitating the creation and maintenance of data standards, tools, and methods for conducting research in therapeutic areas important to public health. 

The purpose of this TAUG-Nutrition is to describe how to use CDISC standards to represent data pertaining to nutrition studies. This Version 1.0 focuses on infant nutrition, food and fluid intake, stool sampling, and questionnaires (specific to clinical studies in nutrition), and includes concepts for both adult and pediatric populations.

Nutrition concepts covered in this guide were selected from concepts identified by 1 or more nutrition stakeholders as important, and which were not addressed or not completely addressed by existing CDISC standards and implementation guides. This TAUG does not provide guidance on what data is needed for regulatory submission or approval; it only provides advice on how to represent data in a standard form. The examples included are intended to show how particular kinds of data can be represented using CDISC standards. Note: Examples are only examples and should not be over-interpreted.

This first version of the TAUG-Nutrition focuses on how to represent data using the Study Data Tabulation Model (SDTM). There are some examples of Clinical Data Acquisition Standards Harmonization (CDASH) implementation. Future versions of this guide may include additional CDASH and Analysis Data Model (ADaM) representations.

How to Read This Document

  1. First, read the CDASH Implementation Guide (CDASHIG); the SDTM and the SDTM Implementation Guide for Human Clinical Trials (SDTMIG); and the SDTM Implementation Guide for Pharmacogenomics/Genetics (SDTMIG-PGx) NUT-49 - Getting issue details... STATUS v1.0 to gain some familiarity with the models and their general implementation in human clinical trials. These standards are available from: http://www.cdisc.org/cdashhttp://www.cdisc.org/sdtm, and https://www.cdisc.org/standards/foundational/pgx, respectively.
  2. Next, read Introduction to Therapeutic Area Standards to be sure to know what to expect from a TAUG.
  3. Read this guide in its entirety, without skipping any sections, at least once.
  4. Finally, revisit any sections of particular interest.

Draft standards of interest to this document are listed at: https://wiki.cdisc.org/x/w42zAg.

Some things to bear in mind while reading this document:

  • This document does not replace or supersede the foundational CDISC standards or their implementation guides, and should not be used as a substitute for any other CDISC standard.
  • This document does not repeat content already published in another CDISC standard.
  • This document is not and does not try to be an exhaustive documentation of every possible kind of data that could be collected in relation to nutritional research. 
  • The advice and examples presented in this document are influenced by ongoing internal standards development at CDISC. If a modeling approach seems inconsistent with a published standard, it may be a genuine error, but it also could be a reflection of potential or upcoming changes to the standard. 
  • The examples in this document use CDISC Controlled Terminology where possible, although some values that seem to be controlled terminology may still be under development at the time of publication, or even especially plausible "best-guess" placeholder values. Do not rely on any source other than the CDISC value set in the NCI Terminology Resources (available at http://www.cancer.gov/research/resources/terminology/cdisc) for controlled terminology. 

Organization of This Document

This document is divided into the following sections:

  • Section 1, Introductionprovides an overall introduction to the purpose and goals of the Nutrition project.
  • Section 2, Overview of Nutrition, provides a general overview ot the concepts contained in this document.
  • Section 3, Food and Fluid Intake, covers an overview of food and fluid intake in nutrition studies. SDTM modeling is not included in this TAUG as this will be covered in the Combination Therapy User Guide. NUT-50 - Getting issue details... STATUS
  • Section 4, Infant Nutrition, covers data that are usually related to dispensing of infant nutrition studies as well as examples of data collected on daily feeding activities.
  • Section 5, Stool Samples and Stool Assessments, covers data related to baseline and on-study stool sample collection, processing, and characteristics, and bowel associated symptoms. NUT-51 - Getting issue details... STATUS
  • Section 6, Questionnaires, Ratings, and Scales, highlights these items as they are related to nutrition studies.
  • Appendices provide additional background material and describe other supplemental material relevant to nutritional research.

CDASH Metadata and Annotated CRFs

CDASH examples include both metadata tables and sample case report forms (CRFs). Each table of CDASH metadata corresponds to an example annotated CRF (aCRF), built directly from the metadata. The annotations show the variables associated with each field in the context of data collection (CDASH) and submission (SDTM); the applicable context is denoted by color. Data that are collected using the same variable name as defined in the SDTMIG are in RED. If the CDASHIG variable differs from the one defined in the SDTMIG, the CDASHIG variable is in GREY. Data collected but not submitted in SDTM-based datasets are denoted as NOT SUBMITTED

The following diagram illustrates how to interpret the annotations. 

Gliffy Macro Error

You do not have permission to view this diagram.

When viewing sample aCRFs, bear in mind that: 

  • Example CRFs are provided to illustrate data collection instruments. They are only examples and are not meant to imply that any particular layout is preferable to another.
  • Example CRFs are best understood in conjunction with their respective metadata tables and/or the CDASH Domain Metadata Tables.
  • Most example CRFs do not include the Highly Recommended header variables. The population of these values is usually determined by the sponsor's data management system.
  • Sponsors are responsible for understanding and implementing CDISC Controlled Terminology where applicable.

Known Issues

  • Non-Standard Variables: To make examples easier to understand, non-standard variables are shown as though they were appended to a dataset rather than being represented as supplemental qualifiers. This is also consistent with a proposed future structure for representing NSVs, a modification of the NSV proposal that went for public review and which is still under development (available in draft form at: http://wiki.cdisc.org/x/Ui68AQ). NUT-52 - Getting issue details... STATUS A list of all NSVs used in this document, and the variable-level metadata that might become normative for the NSVs should they be promoted to standard variables, is provided in Appendix C, Non-Standard Variables

  • Baseline Stool Information: In this version of the TAUG-Nutrition, baseline bowel movement frequency and stool consistency NUT-55 - Getting issue details... STATUS has been represented as findings about bowel movement events in the FA domain NUT-53 - Getting issue details... STATUS . There have been discussions within the Global Governance Group (GGG) about modeling this type of data in the new Gastrointestinal (GI) domain. The advice from the GGG was to solicit feedback during the public review period NUT-54 - Getting issue details... STATUS and then re-address the modeling of this data during the public review comment resolution period.
  • Timing Variables: The time when a subject completes diary information may not be defined precisely by the sponsor. Instructions to subjects filling out a diary card might refer to calendar days (e.g., "Complete this diary with any relevant information from 00:00 on Day 1 to 11:59 on Day 1"), or might ask the subject to complete the diary card at the end of the day before retiring for the night (in which case any diary information after they retired for the night would be captured on the next day's diary). In the examples in this document, the --TPT value "END OF DIARY DAY X" is used to represent imprecise timing of diary data collection. NUT-56 - Getting issue details... STATUS The variables --EVLINT and --EVINTX are used to capture the evaluation interval. However, values such as -P1D are not intended to imply that data are collected in strict 24-hour intervals based on the time of  (e.g., 21:30 on one day to 21:30 on the next day).
  • Stool Measurements in the Lab Domain: At the time of internal review, the tests "Specimen Weight," "Color," and "Consistency" were under discussion by the LB Controlled Terminology Team. Therefore, modeling of these tests may change.
  • Modeling of Meal and Nutrient Data: The Combination Therapy sub-team are currently looking at the modeling of "product" and "ingredient" data in order to provide a consistent modeling approach across various projects. The modeling of meal, ingredients, and nutrient content as well as feeding recipes used in infant nutrition falls under the scope of the CT team. Modeling of these types of data is therefore not shown in this version of the TAUG-Nutrition.
  • Proposed Amendment to the Drug Accountability Domain: A proposal has been submitted to change the domain description from "drug accountability" to "product accountability" in order to extend the use of this domain. It is expected that this will be implemented in a future version of the SDTMIG. At the time of public review of this document, a draft domain has been created to document these changes. Please refer to Product Accountability (DA) for more information.
  • Representing Total Number of Breastfeeding Feeds per Day: This example uses the NSV EXNADEVI to represent the number of breastfeeding feeds per day. The modeling of this example is still under discussion and users are warned that this modeling may be subject to change.

Overview of Nutrition

The concepts in Figure 2.1 were identified by one or more nutrition stakeholders as important concepts related to nutrition research. These concepts fall into 4 main categories:

  1. Food & fluid Intake
  2. Infant nutrition
  3. Stool sampling and assessments
  4. Questionnaires specific to clinical studies in nutrition

The concepts were developed to include both adult and pediatric populations.

NUT-58 - Getting issue details... STATUS

Figure 2.1 Concept Map: Overview of Nutrition

Concept Map: Overview of Nutrition

Food and Fluid Intake

Food and fluid intake data represent nutrients (ingredients) in a consumed meal (regimen) composed of food and other sources of nutrition, including beverages. The nutrient amounts are derived from collected data on the quantities of products within a meal, and data on the nutrients within products. 

Currently, there is no consensus regarding the best way to represent food and fluid intake data in the SDTM. Various strategies have been used across published standards to represent this type of "parent" and "child" data. The Combination Therapy sub-team is focused on finding a unified approach that can be applied across all disease areas and will take account of this nutrition concept.

Infant Nutrition

Clinical research on infant nutrition is conducted in full conformance with the principles of the World Medical Association Declaration of Helsinki[1] and the International Conference on Harmonisation (ICH) guidelines for Good Clinical Practice[2], as appropriate for nutritional products. NUT-14 - Getting issue details... STATUS  Studies to determine the clinical effects of a product can be investigated in observational studies as well as interventional studies with the object of ascertaining its safety and/or efficacy.

The World Health Organization recommends exclusive breastfeeding for the first 6 months of life, and thereafter with complementary feeding up to 2 years of age and beyond.[3] Breastfeeding subjects are often included in the study protocol and used as a reference.

Pre-term infant nutrition is often fortified and the caloric density determined. The subjects in a pre-term study can also receive fortified or unfortified human milk from the mother or from a donor. The modeling of pre-term infant nutrition is being handled by the Combination Therapy sub-team, focusing on finding a unified approach that can be applied across all disease areas and which will take account of this nutrition concept; it is therefore not included in this document.

Figure 4.1 below represents the concepts of interest in this document to feed preparation, administration and events related to feeding.

Figure 4.1 Concept Map: Infant Nutrition

Concept Map: Infant Nutrition


Amount of Study Product Dispensed and Returned

In some nutritional studies, a supply of study product may be provided to the infant's caregiver, to be used between 2 scheduled visits. The data collected on this can be represented in the DA domain.

Example

In this study, the sponsor dispensed a number of cans to the subject to use between the study visits. In this study, it was important to note the number of opened and unopened cans returned (i.e., the volume remaining in the unopened cans was not required to be collected); the variable DACAT was used to represent "Opened" and "Unopened" cans returned.

 da.xpt
Row 1:

Shows that at the first visit NUT-122 - Jira project doesn't exist or you don't have permission to view it. on Day 1, 30 cans of study product were dispensed to the subject.

Row 2:Shows that at the second visit on Day 21, 9 cans of unopened study product were returned by the subject.
Row 3:Shows that at the second visit on Day 21, 1 can of opened study product was returned by the subject.

da.xpt

RowSTUDYIDDOMAINUSUBJIDDASEQDAREFIDDASPIDDATESTCDDATESTDACATDASCATDAORRESDAORRESUDASTRESCDASTRESNDASTRESUDASTATDAREASNDVISITNUMDADTCDADY
 1 ABCDA1011
1DISPAMTDispensed AmountStudy Product
30CAN3030

CAN



12017-05-011
 2 ABCDA1012
1RETAMTReturned AmountUnopened Study Product
9CAN99CAN

2 2017-05-21 21
3ABCDA1013
1RETAMTReturned AmountOpened Study Product
1CAN11CAN

22017-05-2121

Daily Feeding

The infant nutrition product as described in the following example is a blinded infant formula powder for term infants provided in cans. It is very common for young infants to spit up some of the formula and the occurrence of spitting up was recorded. This is sometimes limited to a certain period after the feeding. In most studies, the daily intake NUT-102 - Getting issue details... STATUS is recorded by the caregivers in a diary.

Example

In this example, only the total volume of blinded infant formula administered at each feed was collected. The Exposure as Collected (EC) domain is used to represent data on exposure as collected (e.g., in a blinded fashion). Occurrences of "spitting up" or "vomiting" within 1 hour of feeding were also collected. Note that because this information is collected on a daily diary, line numbers start at 1 for each diary day. Because this variable alone cannot be used to link the Exposure as Collected (EC) and Clinical Events (CE) dataset, ECLNKID and CELNKID is formed from the line number and day number from the diary which, when combined, is a unique identifier and is used in the RELREC linking relationship.

 ec.xpt
Row 1:Shows the volume of blinded study Formula A consumed by the infant on the first feed of the diary (Day 1).
Row 2:Shows the volume of blinded study Formula B consumed by the infant on the second feed of the diary (Day 1).

ec.xpt

Row

STUDYID

DOMAIN

USUBJID

ECSEQ

ECLNKID

ECTRT

ECDOSE

ECDOSU

ECDOSFRM

ECROUTE

ECSTDTC

ECENDTC

ECSTDY

ECENDY

1ABCEC1011D1-1Feeding Formula A50mLSUSPENSIONORAL2017-05-19T13:002017-05-19T13:0011
2ABCEC1012D1-2Feeding Formula B60mLSUSPENSIONORAL2017-05-19T19:002017-05-19T19:0011

"Spit-up" and "Vomit" information is represented in the CE domain.

 ce.xpt
Rows 1, 2:Show the response to the "spitting up" and "vomiting" questions on the first feed of the diary (Day 1).
Rows 3, 4:Show the response to the "spitting up" and "vomiting" questions on the second feed of the diary (Day 1).

ce.xpt

Row

STUDYID

DOMAIN

USUBJID

CESEQ

CEGRPID

CELNKID

CETERM

CEPRESP

CEOCCUR

CEDTC

CEDY

CEEVINTX

1ABCCE10111D1-1VomitingYN2017-05-191Within 1 hour after feeding
2ABCCE10121D1-1Spitting upYY2017-05-191Within 1 hour after feeding
3ABCCE10132D1-2Vomiting
YN2017-05-191Within 1 hour after feeding
4ABCCE10142D1-2Spitting up
YY2017-05-191Within 1 hour after feeding

Once the study was unblinded, the EC data could be represented in the EX domain, with ECLNKID and EXLNKID again acting as a unique identifier used in the RELREC linking relationship. Note that if this was an unblinded study, then the data may have been represented directly in EX without the need to use the EC domain. Please refer to Section 6.1 of SDTMIG v3.3, which describes the use of the EC and EX domains and the requirements to document derivations used to show data in EX in the define.xml file.

 ex.xpt
Row 1:Shows the volume of study formula consumed by the infant on the first feed of the diary (Day 1).
Row 2:Shows the volume of study formula consumed by the infant on the second feed of the diary (Day 1).

ex.xpt

Row

STUDYID

DOMAIN

USUBJID

EXSEQ

EXLNKID

EXTRT

EXDOSE

EXDOSU

EXDOSFRM

EXROUTE

EXSTDTC

EXENDTC

EXSTDY

EXENDY

1ABCEX1011D1-1Nutra50mLSUSPENSIONORAL2017-05-19T13:002017-05-19T13:0011
2ABCEX1012D1-2Nutra-Plus60mLSUSPENSIONORAL2017-05-19T19:002017-05-19T19:0011

The relrec.xpt example is represented below.

 relrec.xpt

relrec.xpt

Row

STUDYID

RDOMAIN

USUBJID

IDVAR

IDVARVAL

RELTYPE

RELID

1ABCEC
EXLNKID
ONE1
2ABCEX
ECLNKID
ONE1
2ABCCE
CELNKID
MANY1

The infant nutrition product as described in the following example is a blinded infant formula powder for term infants provided in cans. To prepare the formula, the formula powder was measured as spoons and mixed with a specified amount of water. The volume of prepared formula was collected and then fed to the infant (i.e., subject in the study) and any leftover volume was again measured.

Example

In this blinded study, the sponsor gave the infant caregiver a tin of formula and a daily diary to complete. The caregiver made up a bottle of formula using a set number of spoons of formula with water. The volume of formula prepared and volume of formula left after feeding was recorded. For the purposes of this example only the first 3 feeds are recorded.

The volume prepared and the volume remaining after feeding is represented in the DA (Product Accountability) domain. Please see Section 1.4, Known Issues, for information on a proposal to extend the use of the DA domain to include cover "product" accountability.

 da.xpt
Rows 1-2:Show the volume of formula prepared and the volume of formula left after feeding for the first feed of the diary (Day 1).
Rows 3-4:Show the volume of formula prepared and the volume of formula left after feeding for the second feed of the diary (Day 1).
Rows 5-6:Show the volume of formula prepared and the volume of formula left after feeding for the third feed of the diary (Day 2).

da.xpt

RowSTUDYIDDOMAINUSUBJIDDASEQDAGRPIDDASPIDDATESTCDDATESTDACATDASCATDAORRESDAORRESUDASTRESCDASTRESNDASTRESUDASTATDAREASNDDADTCDADY
 1 ABCDA101111PREPAMTPrepared AmountStudy Product
 100mL100100mL

2017-05-19  1
 2 ABCDA101211REMAMTRemaining AmountStudy Product
 15mL1515mL

 2017-05-19 1
3ABCDA101322PREPAMTPrepared AmountStudy Product
100mL100100mL

2017-05-19 1
4ABCDA101422REMAMTRemaining AmountStudy Product
25mL2525mL

 2017-05-19 1
5ABCDA101531PREPAMT
Prepared AmountStudy Product
100mL100100mL

 2017-05-202
6ABCDA101631REMAMTRemaining AmountStudy Product
10mL1010mL

 2017-05-202

The actual amount of unblinded study product exposed to the infant is represented in the EX domain. The sponsor chose to represent this as a weight (g) of study product actually consumed by the infant. This was calculated using the actual amount of feed consumed by the infant (total volume prepared minus total volume remaining) NUT-133 - Getting issue details... STATUS , and then converting the total number of spoons used to make up the product to the actual number of spoons consumed. Note that in this study each spoon used was 15 g of study product and 2 spoons of formula was always used to prepare the feed. It is generally accepted that this type of derived exposure information can be represented in SDTM in the EX domain. Please refer to Section 6.1 of SDTMIG v3.3, which describes the use of EC and EX domains and the requirements to document the derivations used to show data in EX in the define.xml file.

 ex.xpt
Row 1:Shows the weight of study formula consumed by the infant on the first feed of the diary (Day 1).
Row 2:Shows the weight of study formula consumed by the infant on the second feed of the diary (Day 1).
Row 3:Shows the weight of study formula consumed by the infant on the third feed of the diary (Day 2).

ex.xpt

Row

STUDYID

DOMAIN

USUBJID

EXSEQ

EXLNKID

EXTRT

EXDOSE

EXDOSU

EXDOSFRM

EXROUTE

EXSTDTC

EXENDTC

EXSTDY

EXENDY

1ABCEX10111Nutra25.5gPOWDER, FOR SOLUTIONORAL2017-05-192017-05-1911
2ABCEX10122Nutra22.5gPOWDER, FOR SOLUTIONORAL2017-05-192017-05-1911
3ABCEX10133Nutra

27

gPOWDER, FOR SOLUTIONORAL2017-05-202017-05-2022

The relrec.xpt example is represented below.

 relrec.xpt

relrec.xpt

Row

STUDYID

RDOMAIN

USUBJID

IDVAR

IDVARVAL

RELTYPE

RELID

1ABCDA
DAGRPID
MANY1
2ABCEX
EXLNKID
ONE1

In some clinical studies, breastfeeding may be used as a comparator to study products and therefore may need to be represented as "exposure" information. This data may be collected in a variety of formats (e.g., start and stop times of individual feeds, duration of each breast feeding episode/number of minutes on the breast, total breast feeding time for a day). Breastfeeding may also be collected as “background” data, in which case it would be represented in the draft Meal Data (ML) domain NUT-101 - Getting issue details... STATUS . If represented in ML, the data structure would look the same as the Exposure (EX) examples apart from with the ML domain code/variables.

Example

This example shows representing breastfeeding in EX with individual start and stop times per feed.

 ex.xpt
Row 1:Shows an example of breast-fed milk. Note that there is no EXDOSE because the actual amount of milk fed can not be determined when feeding is direct from the breast.
Row 2:Shows an example of expressed breast milk that is fed using a bottle. The amount of milk consumed is represented in EXDOSE, as this was collected based on the volume fed from the bottle.

ex.xpt

Row

STUDYID

DOMAIN

USUBJID

EXSEQ

EXTRT

EXDOSE

EXDOSU

EXDOSFRM

EXROUTE

EXSTDTC

EXENDTC

1ABCEX1011Breast Milk


ORAL2017-05-19T13:002017-05-19T13:20
2ABCEX1012Breast Milk50mL
ORAL2017-05-19T17:002017-05-19T17:15

Example

This example shows representing breastfeeding as a duration in minutes per feed. Note that the SDTM variable EXDUR variable can only be used if this data is collected on the CRF and cannot be derived from start and stop times. If duration needs to be calculated from start and stop times, this should be done in an ADaM dataset.

 ex.xpt

ex.xpt

Row

STUDYID

DOMAIN

USUBJID

EXSEQ

EXTRT

EXDOSE

EXDOSU

EXDOSFRM

EXROUTE

EXSTDTC

EXENDTC

EXDUR
1ABCEX1011Breast Milk


ORAL2017-05-192017-05-19PT20M
2ABCEX1012Breast Milk


ORAL2017-05-192017-05-19PT15M

Example

This example shows representing breastfeeding as a total number of feeds per day.

 ex.xpt

ex.xpt

Row

STUDYID

DOMAIN

USUBJID

EXSEQ

EXTRT

EXDOSE

EXDOSU

EXDOSFRM

EXROUTE

EXSTDTC

EXENDTC


EXNADEVI
1ABCEX1011Breast Milk


ORAL2017-05-192017-05-19
4

EX NSV Metadata

Stool Samples and Stool Assessments

In some nutritional studies, stool and gastrointestinal (GI) symptoms can be important outcome and safety parameters in both adult and infant studies. This data may then be used to assess if the study product has had any effect on stool frequency/consistency by comparing information collected at baseline with data collected during the study.

Stool assessments can be divided into two categories: (1) Bowel Movements and (2) Bowel Associated Symptoms.

Bowel Movement data is related to assessment of the bowel movement (e.g., frequency of the stool). Assessment of Stool relates to stool color and consistency and also laboratory measurements from feces samples (e.g., pH and bacterial composition).

Bowel Associated Symptoms represent the assessment of symptoms related to bowel movement (e.g., flatulence, abdominal distension, constipation).

Figure 5.1 shows the various assessments that may be performed on bowel movements and stool samples.  NUT-59 - Getting issue details... STATUS

Figure 5.1 Concept Map: Stool Assessments

Concept Map: Stool Assessments


Types of Diary Collection for Stool Samples and Stool Assessments

Data collection on bowel movements is usually conducted using diaries completed by subject or other evaluator (e.g., caregiver). Fecal samples may also be taken by the subject or caregiver, or at hospitals or clinics.

Figure 5.1.1 represents three types of diary data collection:

  • Subject Recall: At the visit, the subject is asked to recall from memory data such as the average number of stool episodes per day, or typical consistency of the stool over a set number of days prior to the visit. The subject is not required to keep detailed information on the number of episodes/type of consistency, but estimates these based on memory recall.
  • End of Day Diary Completion: The subject is asked to complete a diary at the end of each day with the total number of stool episodes and typical consistency over the day.
  • Each Episode Diary Completion: The subject is asked to complete a diary with the time of each stool episode and the typical consistency of that stool episode.

Figure 5.1.1 Types of Diary Collection

Types of Diary Collection

When providing diaries for a subject to complete, it is important to provide the subject with instructions on how and when to complete the diary; those instructions must be understood by all functions within the study team. Although this may differ from protocol to protocol, detailed, unambiguous instructions will help ensure that data are collected in a consistent format across all subjects. This may be particularly important when analyzing the data. Some diary completion instructions may be as simple as "Please record all bowel movements that occurred between 00:00 and 23:59 on this day." It may also be important to provide additional information on how subjects should record data if, for example, they retire to bed before or after midnight and then they have a bowel movement prior to or after midnight. Providing instructions on which diary day to record these episodes will help ensure that data are recorded consistently across all subjects.

Note: Some sponsors may use a standard instrument to collect information on the color/consistency of stool samples. SDTM modeling of these concepts should therefore follow the separate supplements for these scales. Please refer to Section 6, Questionnaires, Ratings, and Scales, for scales that have been identified for nutritional research.

The examples below show how subject recall, end of day, and each episode diary data may be collected using CDASH standards and represented in SDTM standards.

Bowel Movements - Subject Recall

Example

This example shows how to represent baseline stool information for recall average number of bowel movements and recall typical stool consistency over a 3-day period prior to the baseline visit.

At the baseline visit, the subject was asked:

  • What was the average number of stool episodes per day over the 3 days prior to the visit?
  • What was the typical consistency of the stools over the 3 days prior to the visit?

FAOBJ Hidden/pre-populated
BOWEL MOVEMENT
FAEVINTX FAEVINTX and LBEVINTX Hidden/pre-populated
PREVIOUS 3 CALENDAR DAYS
Record the average number of stool episodes per day over the last 3 days that the subject recalls from memory.
EVENTFRQ_FAORRES FAORRES where FATESTCD = "EVENTFRQ"
_________________
EVENTFRQ_FASOURCE NSV.FASOURCE where FATESTCD = "EVENTFRQ" Hidden/pre-populated
RECALL
EVENTFRQ_FACOLSRT NSV.FACOLSRT where FATESTCD = "EVENTFRQ" Hidden/pre-populated
AVERAGE
EVENTFRQ_FATEST FATEST where FATESTCD = "EVENTFRQ" Hidden/pre-populated
Event Frequency
EVENTFRQ_FAORRESU FAORRESU where FATESTCD = "EVENTFRQ" Hidden/pre-populated
/day
Record the subject's assessment of the typical consistency of their stools over the last 3 days based on their recall from memory. Over the last 3 days what was the typical consistency of bowel movements?
CONSIST_LBORRES LBORRES where LBTESTCD = "CONSIST"
CONSIST_LBSOURCE NSV.LBSOURCE where LBTESTCD = "CONSIST" Hidden/pre-populated
RECALL
CONSIST_LBCOLSRT NSV.LBCOLSRT where LBTESTCD = "CONSIST" Hidden/pre-populated
TYPICAL
CONSIST_LBTEST LBTEST where LBTESTCD = "CONSIST" Hidden/pre-populated
Consistency
 View CRF Metadata

Columns whose headers are shaded blue and rows whose Field ID are shaded blue contain metadata that were developed for this example annotated CRF, and are not part of the CDASH model or CDASHIG.

Observation ClassOrder Number Domain TAUG ReferenceCDASH Variable NameCDASHIG Variable Label  Question TextPromptField TypeCase Report Form Completion InstructionsInformation for SponsorsTA Specific Usage RulesSDTMIG TargetSDTM Variable Mapping Controlled Terminology CodeList NamePre-Defined ValuesValue that appears on the CRF but is not entered by the user DIsplayed QueryHidden?
Findings01FATAUG-NUT v1.0-Baseline Information on bowel movementsFAOBJFinding About ObjectN/AN/AtextN/A

FAOBJ
N/A
BOWEL MOVEMENT
hidden
Findings02FATAUG-NUT v1.0-Baseline Information on bowel movementsFAEVINTXEvaluation Interval TextN/AN/AtextN/A

FAEVINTX and LBEVINTX
N/A
PREVIOUS 3 CALENDAR DAYS
hidden
Findings03FATAUG-NUT v1.0-Baseline Information on bowel movements EVENTFRQ_FAORRES
Over the last 3 days what was the average number of bowel movements per day?Avg Number of Bowel MovementstextRecord the average number of stool episodes per day over the last 3 days that the subject recalls from memory.

FAORRES FAORRES where FATESTCD = "EVENTFRQ"N/A



Findings04FATAUG-NUT v1.0-Baseline Information on bowel movementsEVENTFRQ_FASOURCESource of DataN/AN/Atext


NSV.FASOURCENSV.FASOURCE where FATESTCD = "EVENTFRQ"N/A
RECALL
hidden
Findings04FATAUG-NUT v1.0-Baseline Information on bowel movementsEVENTFRQ_FACOLSRTCollected Summary Result TypeN/AN/Atext


NSV.FACOLSRT NSV.FACOLSRT where FATESTCD = "EVENTFRQ"N/A
AVERAGE
hidden
Findings05FATAUG-NUT v1.0-Baseline Information on bowel movementsEVENTFRQ_FATESTFindings About Test NameN/AN/Atext


FATEST FATEST where FATESTCD = "EVENTFRQ"N/A
Event Frequency
hidden
Findings06FATAUG-NUT v1.0-Baseline Information on bowel movementsEVENTFRQ_FAORRESUFindings About Result UnitN/AN/Atext


FAORRESU FAORRESU where FATESTCD = "EVENTFRQ"N/A
/day
hidden
Findings07LBTAUG-NUT v1.0-Baseline Information on bowel movements CONSIST_LBORRESResult or Finding in Original UnitOver the last 3 days what was the typical consistency of bowel movements?Typical Consistency of Bowel MovementstextRecord the subject's assessment of the typical consistency of their stools over the last 3 days based on their recall from memory. Sponsors should provide guidelines to subjects on how to evaluate "typical" consistency.
FAORRES LBORRES where LBTESTCD = "CONSIST"N/AWatery;Loose;Soft;Formed;Hard


Findings
LBTAUG-NUT v1.0-Baseline Information on bowel movementsCONSIST_LBSOURCESource of DataN/AN/Atext


NSV.LBSOURCENSV.LBSOURCE where LBTESTCD = "CONSIST"

RECALL
hidden
Findings08LBTAUG-NUT v1.0-Baseline Information on bowel movementsCONSIST_LBCOLSRTCollected Summary Result TypeN/AN/Atext


NSV.LBCOLSRT

NSV.LBCOLSRT

where LBTESTCD = "CONSIST"

N/A
TYPICAL
hidden
Findings09LBTAUG-NUT v1.0-Baseline Information on bowel movementsCONSIST_LBTESTName of Measurement, Test or ExaminationN/AN/Atext


LBTEST LBTEST where LBTESTCD = "CONSIST"N/A
Consistency
hidden
See Section 1.3, CDASH Metadata and Annotated CRFs, for explanation of annotations.

The NSV FASOURCE was used to represent that that the results of this data were obtained using subject recall at the visit, as opposed to information gathered from a data collection tool (e.g., patient daily diary). Recalled average number of bowel movements over a 3-day period prior to the visit is represented in the FACE domain. The NSV FACOLSRT was used to represent that the collected result type was an average.

 face.xpt

face.xpt

Row

STUDYID

DOMAIN

USUBJID

FASEQ

FATESTCD

FATEST

FAOBJ

FAORRES

FAORRESU

FASTRESC

FASTRESNFASTRESU

VISITNUM

VISIT

VISITDY

FADTC

FAEVINTX
FACOLSRTFASOURCE
1NUTR123FANUTR123_0011EVENTFRQEvent FrequencyBOWEL MOVEMENT3/day33/day1Baseline-12017-01-05PREVIOUS 3 CALENDAR DAYS
AVERAGERECALL

FACE NSV Metadata

Recalled typical consistency of the stool over a 3-day period prior to the visit  is represented in the LB domain. The consistency of the stool was assessed by the subject at the end of the day therefore LBEVAL was used to represent this. The NSVs LBCOLSRT and LBSOURCE were used to represent that the collected result was typical and that this was information recalled from the subject.
 lb.xpt

lb.xpt

Row

STUDYID

DOMAIN

USUBJID

LBREFID

LBTESTCD

LBTEST

LBCAT

LBORRES

LBORRESU

LBORNRLOLBORNRHI

LBSTRESC

LBSTRESNLBSTRESULBSTNRLOLBSTNRHILBSTREFCLBNRINDLBSPECLBEVAL

VISITNUM

VISIT

VISITDY

LBDTC

LBEVINTX
LBCOLSRTLBSOURCE
1NUTR123LBNUTR123_001
CONSISTConsistency
Loose


Loose





STOOLSUBJECT1Baseline-12017-01-05PREVIOUS 3 CALENDAR DAYS
TYPICALRECALL

LB NSV Metadata

Bowel Movements - End of Day

Patient diaries can be used to collect information on number of stools and consistency on a daily basis. In this case, the calculation of average number of stools or the typical consistency over the 3-day period may be calculated in an ADaM dataset from this source data.

Example

This example shows baseline stool information for actual daily number of bowel movements and typical stool consistency each day over a 3-day period prior to the baseline visit. Please note that it may be important for sponsors to provide additional instructions to the diary (e.g., how a subject should evaluate their consistency if they had 1 loose and 1 hard stool in a day).

The sponsor chose to use a paper diary that was given to subject prior to the visit and then handed back at the visit where this was entered into the EDC system.

FAOBJ Hidden/pre-populated
BOWEL MOVEMENT
FAEVLINT FAEVLINT and LBEVLINT Hidden/pre-populated
-P1D
Select the diary day being entered. What is the diary day?
FATPT FATPT and LBTPT
Record the date the subject indicated the diary was completed.
FADAT FADTC and LBDTC
_________________
Record the number of bowel movements that the subject had on this day.
EPSDNUM_FAORRES FAORRES where FATESTCD = "EPSDNUM"
_________________
LBSPEC Hidden/pre-populated
STOOL
Record the typical consistency of the subject's stools over this day. What is the typical consistency of bowel movements as reported by the subject?
CONSIST_LBORRES LBORRES where LBTESTCD = "CONSIST"
CONSIST_LBCOLSRT NSV.LBCOLSRT where LBTESTCD = "CONSIST" Hidden/pre-populated
TYPICAL
 View CRF Metadata

Columns whose headers are shaded blue and rows whose Field ID are shaded blue contain metadata that were developed for this example annotated CRF, and are not part of the CDASH model or CDASHIG.

Observation ClassOrder Number Domain TAUG ReferenceCDASH Variable NameCDASHIG Variable Label  Question TextPromptField TypeCase Report Form Completion InstructionsInformation for SponsorsTA Specific Usage RulesSDTMIG TargetSDTM Variable Mapping Controlled Terminology CodeList NamePre-Defined ValuesValue that appears on the CRF but is not entered by the user DIsplayed QueryHidden?
Findings01FATAUG-NUT v1.0-Baseline Information on bowel movementsFAOBJFinding About ObjectN/AN/AtextN/AN/A
FAOBJ
N/A
BOWEL MOVEMENT
hidden
Findings02FATAUG-NUT v1.0-Baseline Information on bowel movementsFAEVLINTEvaluation IntervalN/AN/AtextN/AN/A
FAEVLINT and LBEVLINT
N/A
-P1D
hidden
Findings03FATAUG-NUT v1.0-Baseline Information on bowel movementsFATPTPlanned Time Point NameWhat is the diary day?Diary DaytextSelect the diary day being entered.N/A
FATPT and LBTPT
N/AEND OF DIARY DAY -3;END OF DIARY DAY -2;END OF DIARY DAY -1


Findings04FATAUG-NUT v1.0-Baseline Information on bowel movementsFADATDate of CollectionWhat is the diary date?Diary DatetextRecord the date the subject indicated the diary was completed.N/A
FADTC and LBDTC





Findings05FATAUG-NUT v1.0-Baseline Information on bowel movements EPSDNUM_FAORRESFindings About ResultWhat is the number of bowel movements reported by the subject?Number of bowel movementstextRecord the number of bowel movements that the subject had on this day.An example of a CDASH denormalized variable name. This name includes the components needed to map to SDTM
FAORRES FAORRES where FATESTCD = "EPSDNUM"N/A



Findings06LBTAUG-NUT v1.0-Baseline Information on bowel movementsLBSPECSpecimen TypeN/AN/AtextN/AN/A
LBSPEC
N/A
STOOL
hidden
Findings07LBTAUG-NUT v1.0-Baseline Information on bowel movements CONSIST_LBORRESFindings About ResultWhat is the typical consistency of bowel movements as reported by the subject?Typical bowel movement consistencytextRecord the typical consistency of the subject's stools over this day.An example of a CDASH denormalized variable name. This name includes the components needed to map to SDTM
LBORRES LBORRES where LBTESTCD = "CONSIST"N/AWatery;Loose;Soft;Formed;Hard


Findings08LBTAUG-NUT v1.0-Baseline Information on bowel movementsCONSIST_LBCOLSRTCollected Summary Result TypeN/AN/Atext
An example of a CDASH denormalized variable name. This name includes the components needed to map to SDTM
NSV.LBCOLSRT NSV.LBCOLSRT where LBTESTCD = "CONSIST"N/A
TYPICAL
hidden
See Section 1.3, CDASH Metadata and Annotated CRFs, for explanation of annotations.

Because this data is based on a diary, NUT-89 - Getting issue details... STATUS the sponsor chose to leave the variable VISITNUM blank as these assessments are not completed at a specified protocol visit. 

The total daily number of bowel movements for each of the 3 days of the diary is represented in the FACE domain.

 face.xpt

face.xpt

Row

STUDYID

DOMAIN

USUBJID

FASEQ

FAREFID

FASPID

FATESTCD

FATEST

FAOBJ

FAORRES

FAORRESU

FASTRESC

FASTRESNFASTRESUFAEVAL

VISITNUM

FADTC

FATPTFATPTNUMFAEVLINT
1NUTR123FANUTR123_0011D-3_11EVENTFRQ

Event Frequency

BOWEL MOVEMENT2/day 22/daySUBJECT
2017-01-02END OF DIARY DAY -3-3-P1D
2NUTR123FANUTR123_0012D-2_12EVENTFRQEvent FrequencyBOWEL MOVEMENT3/day33/daySUBJECT
2017-01-03END OF DIARY DAY -2-2-P1D
3NUTR123FANUTR123_0013D-1_13EVENTFRQEvent FrequencyBOWEL MOVEMENT2/day22/daySUBJECT
2017-01-04END OF DIARY DAY -1-1-P1D
The typical stool consistency bowel movements for each of the 3 days of the diary  is represented in the LB domain. The consistency of the stool was assessed by the subject at the end of the day therefore LBEVAL was used to represent this. If a caregiver was assessing the stool sample (e.g., for an infant) then LBEVAL would be "CAREGIVER."
 lb.xpt

lb.xpt

Row

STUDYID

DOMAIN

USUBJID

LBSEQ

LBREFID

LBSPID

LBTESTCD

LBTEST

LBCAT

LBORRES

LBORRESULBORNRLOLBORNRHI

LBSTRESC

LBSTRESNLBSTRESULBSTNRLOLBSTNRHILBSTREFCLBNRINDLBSPECLBEVALLBLOBXFL

VISITNUM

LBDTC

LBTPTLBTPTNUMLBEVLINT
LBCOLSRT
1NUTR123LBNUTR123_0011D-3_11CONSISTConsistency
Loose


Loose





STOOLSUBJECT

2017-01-02END OF DIARY DAY -3-3-P1D
TYPICAL
2NUTR123LBNUTR123_0012D-2_12CONSISTConsistency
Hard


Hard





STOOLSUBJECT

2017-01-03END OF DIARY DAY -3-2-P1D
TYPICAL
3NUTR123LBNUTR123_0013D-1_13CONSISTConsistency
Loose


Loose





STOOLSUBJECT

2017-01-04END OF DIARY DAY -3-1-P1D
TYPICAL

LB NSV Metadata

The relrec.xpt example is represented below.
 relrec.xpt

relrec.xpt

Row

STUDYID

RDOMAIN

USUBJID

IDVAR

IDVARVAL

RELTYPE

RELID

1NUTR123FA
FAREFID
ONE1
2NUTR123LB
LBREFID
MANY1

Bowel Movements - Each Episode

In some cases patient diaries can also be used to collect information on individual stool episodes and consistency within each day. In this case, the calculation of average number of stools or the typical consistency over the 3-day period may be calculated in an ADaM dataset from this source data.

Example

This example shows baseline stool information for each bowel movement and the corresponding stool consistency for each stool episode over a 3-day period prior to the baseline visit. The sponsor chose to use a paper diary that was given to subject prior to the visit and then handed back at the visit where this was entered into the EDC system.

CETERM Hidden/pre-populated
BOWEL MOVEMENT
Select the diary day being entered What is the diary day?
CETPT CETPT and LBTPT
Record the date the subject indicated the diary was completed
CESTDAT CEDTC and CESTDTC and LBDTC
_________________
CEPRESP Hidden/pre-populated
Y
Indicate if any bowel movements occurred, checking Yes or No. Did the subject have any bowel movements for this day?
CEOCCUR
Record the bowel movement episode number. For each diary day, start the count at 1. What is the clinical event identifier?
CESPID CESPID and LBSPID
Record the start time the subject indicated the bowel movement started
CESTTIM CESTDTC LBDTC
_________________
LBSPEC Hidden/pre-populated
STOOL
Record the consistency of the subject's stool What is the consistency of bowel movement reported by the subject?
CONSIST_LBORRES LBORRES where LBTESTCD = "CONSIST"
Record the color of the subject's stool What is the color of bowel movement reported by the subject?
COLOR_LBORRES LBORRES where FATESTCD = "COLOR"
 View CRF Metadata

Columns whose headers are shaded blue and rows whose Field ID are shaded blue contain metadata that were developed for this example annotated CRF, and are not part of the CDASH model or CDASHIG.

Observation ClassOrder Number Domain TAUG ReferenceCDASH Variable NameCDASHIG Variable Label  Question TextPromptField TypeCase Report Form Completion InstructionsInformation for SponsorsTA Specific Usage RulesSDTMIG TargetSDTM Variable MappingControlled Terminology CodeList NamePre-Defined ValuesValue that appears on the CRF but is not entered by the user DIsplayed QueryHidden?
Findings01CETAUG-NUT v1.0-Baseline Information on bowel movementsCETERMClinical Event Reported TermN/AN/AtextN/A

CETERMCETERMN/A
BOWEL MOVEMENT
Hidden
Findings02CETAUG-NUT v1.0-Baseline Information on bowel movementsCETPTPlanned Time Point NameWhat is the diary day?Diary DaytextSelect the diary day being entered

CETPTCETPT and LBTPTN/ADIARY DAY -3;DIARY DAY -2;DIARY DAY -1


Findings03FATAUG-NUT v1.0-Baseline Information on bowel movementsCESTDATClinical Event Start DateWhat is the diary date?Diary DatetextRecord the date the subject indicated the diary was completedThis date is used to populate CEDTC. It is then combined with the Start Time of the bowel movement to create CESTDTC and FADTC .
CESTDTCCEDTC and CESTDTC and LBDTC




Findings04FATAUG-NUT v1.0-Baseline Information on bowel movementsCEPRESPClinical Event Pre-SpecifiedN/AN/Atext


CEPRESP


Y
Hidden
Findings05FATAUG-NUT v1.0-Baseline Information on bowel movementsCEOCCURClinical Event OccurrenceDid the subject have any bowel movements for this day?Bowel MovementstextIndicate if any bowel movements occurred, checking Yes or No.

CEOCCUR

Yes; No


Findings06FATAUG-NUT v1.0-Baseline Information on bowel movementsCESPIDClinical Event Sponsor-Defined IdentifierWhat is the clinical event identifier?Bowel Movement NumbertextRecord the bowel movement episode number. For each diary day, start the count at 1.

CESPIDCESPID and LBSPIDN/A1; 2; 3; 4; 5; 6; 7; 8; 9; 10


Findings07FATAUG-NUT v1.0-Baseline Information on bowel movementsCESTTIMStart Time of Clinical EventWhat was the bowel movement start time?Start Time of the bowel movementtextRecord the start time the subject indicated the bowel movement startedThis date is used to populate CEDTC. It is then combined with the Start Time of the bowel movement to create CESTDTC and FADTC .
CESTDTCCESTDTC LBDTC




Findings08LBTAUG-NUT v1.0-Baseline Information on bowel movementsLBSPEC
Specimen TypeN/AtextN/A

LBSPEC
N/A
STOOL
Hidden
Findings09LBTAUG-NUT v1.0-Baseline Information on bowel movements CONSIST_LBORRES
What is the consistency of bowel movement reported by the subject?Bowel movement consistencytextRecord the consistency of the subject's stoolAn example of a CDASH denormalized variable name. This name includes the components needed to map to SDTM.
LBORRESLBORRES where LBTESTCD = "CONSIST"N/AWatery; Loose; Soft; Formed; Hard


Findings10LBTAUG-NUT v1.0-Baseline Information on bowel movementsCOLOR_LBORRES
What is the color of bowel movement reported by the subject?Bowel movement colortextRecord the color of the subject's stoolAn example of a CDASH denormalized variable name. This name includes the components needed to map to SDTM.
LBORRESLBORRES where FATESTCD = "COLOR"N/AYellow; Green; Brown; Black


See Section 1.3, CDASH Metadata and Annotated CRFs, for explanation of annotations.


  • Because these data are based on a diary, the sponsor chose to leave the variables VISITNUM blank as these assessments are not completed at a specified protocol visit.
  • Because data were collected on individual bowel movement episodes, these were considered clinical events and therefore data for the occurrence of each episode were represented in the CE domain.
  • The consistency and color of each episode were represented in the Laboratory Findings (LB) domain.
  • Because the sponsor instructed the subject to record the time equivalent to the start of the bowel movement, CESTDTC was used to represent the start date and time of the bowel movement.
  • CEREFID was populated by the sponsor to represent the diary day number and the individual bowel movement (e,g,. D-3_1 represents bowel movement 1 on diary Day -3). The same format was used for LBREFID showing the consistency and color of the stool nut NUT-141 - Getting issue details... STATUS . The CE and LB datasets can therefore be linked based on --REFID variables.
  • The rows are color coded to help identify each day of the diary.

 ce.xpt
Rows 1-3:Show 3 bowel movement episodes on the first day of the diary.
Rows 4-5:Show 2 bowel movement episodes on the second day of the diary.
Rows 6-7:Show 2 bowel movement episodes on the third day of the diary.
Row 8:Shows an example of where there are no bowel movements episodes for the first day of the diary (although this is quite unlikely).
Row 9:Shows an example of where the subject forgot to record any bowel movement episodes for the second day of the diary. In this example, there was just a line struck through the diary with a note of "Forgot to complete." As no other data was recorded by the subject, CEDTC/CESTDTC/CEOCCUR are all blank. The CESTAT and CEREASND variables are used to show that the bowel movement assessments were not done on this day.

ce.xpt

Row

STUDYID

DOMAIN

USUBJID

CESEQ

CEREFIDCESPID

CETERM

CEPRESPCEOCCURCESTATCEREASNDCEDTC

CESTDTC

CETPTCETPTNUM
1NUTR123CENUTR123_0011D-3_11BOWEL MOVEMENTYY

2017-01-022017-01-02 T09:45DIARY DAY -3-3
2NUTR123CENUTR123_0012D-3_22BOWEL MOVEMENTYY

2017-01-022017-01-02 T12:45DIARY DAY -3-3
3NUTR123CENUTR123_0013D-3_33BOWEL MOVEMENTYY

2017-01-022017-01-02 T19:45DIARY DAY -3-3
4NUTR123CENUTR123_0014D-2_11BOWEL MOVEMENTYY

2017-01-032017-01-03 T08:30DIARY DAY -2-2
5NUTR123CENUTR123_0015D-2_22BOWEL MOVEMENTYY

2017-01-032017-01-03 T20:00DIARY DAY -2-2
6NUTR123CENUTR123_0016D-1_11BOWEL MOVEMENTYY

2017-01-042017-01-04 T09:00DIARY DAY -1-1
7NUTR123CENUTR123_0017D-1_22BOWEL MOVEMENTYY

2017-01-042017-01-04 T21:00DIARY DAY -1-1
8NUTR123CENUTR123_0021D-3_11BOWEL MOVEMENTYN

2017-02-12
DIARY DAY -3-3
9NUTR123CENUTR123_0022D-2_11BOWEL MOVEMENTY
NOT DONEFORGOT TO COMPLETE

DIARY DAY -2-2
The following example shows the consistency and color of each stool episode from the CE data above. Note that there is no LB consistency/color data for the last 2 rows of the CE dataset above, because they represent (1) a day when there were no bowel movement episodes and (2) a day when the subject forgot to complete the diary. The consistency of the stool was assessed by the infant's caregiver and therefore LBEVAL was used to represent this. If a subject was assessing their own stool sample then LBEVAL would be "SUBJECT."
 lb.xpt

lb.xpt

Row

STUDYID

DOMAIN

USUBJID

LBSEQ

LBREFID

LBSPID

LBTESTCD

LBTEST

LBCAT

LBORRES

LBORRESULBORNRLOLBORNRHI

LBSTRESC

LBSTRESNLBSTRESULBSTNRLOLBSTNRHILBSTREFCLBNRINDLBSPECLBEVALLBLOBXFL

VISITNUM

LBDTC

LBTPTLBTPTNUM
1NUTR123LBNUTR123_0011D-3_11CONSISTConsistency
Loose


Loose





STOOLCAREGIVER

2017-01-02 T09:45DIARY DAY -3-3
2NUTR123LBNUTR123_0012D-3_11COLORColor
Brown


Brown





STOOLCAREGIVER

2017-01-02 T09:45DIARY DAY -3-3
3NUTR123LBNUTR123_0013D-3_22CONSIST
Consistency
Hard


Hard





STOOLCAREGIVER

2017-01-02 T12:45DIARY DAY -3-3
4NUTR123LBNUTR123_0014D-3_22COLORColor
Brown


Brown





STOOLCAREGIVER

2017-01-02 T12:45DIARY DAY -3-3
5NUTR123LBNUTR123_0015D-3_33CONSIST
Consistency
Loose


Loose





STOOLCAREGIVER

2017-01-02 T19:45DIARY DAY -3-3
6NUTR123LBNUTR123_0016D-3_33COLORColor
Brown


Brown





STOOLCAREGIVER

2017-01-02 T19:45DIARY DAY -3-3
7NUTR123LBNUTR123_0017D-2_11CONSIST
Consistency
Hard


Hard





STOOLCAREGIVER

2017-01-03 T08:30DIARY DAY -2-2
8NUTR123LBNUTR123_0018D-2_11COLORColor
Brown


Brown





STOOLCAREGIVER

2017-01-03 T08:30DIARY DAY -2-2
9NUTR123LBNUTR123_0019D-2_22CONSIST
Consistency
Hard


Hard





STOOLCAREGIVER

2017-01-03 T20:00DIARY DAY -2-2
10NUTR123LBNUTR123_00110D-2_22COLORColor
Brown


Brown





STOOLCAREGIVER

2017-01-03 T20:00DIARY DAY -2-2
11NUTR123LBNUTR123_00111D-1_11CONSIST
Consistency
Hard


Hard





STOOLCAREGIVER

2017-01-04 T09:00DIARY DAY -1-1
12NUTR123LBNUTR123_00112D-1_11COLORColor
Brown


Brown





STOOLCAREGIVER

2017-01-04 T09:00DIARY DAY -1-1
13NUTR123LBNUTR123_00113D-1_22CONSIST
Consistency
Loose


Loose





STOOLCAREGIVER

2017-01-04 T21:00DIARY DAY -1-1
14NUTR123LBNUTR123_00114D-1_22COLORColor
Brown


Brown





STOOLCAREGIVER

2017-01-04 T21:00DIARY DAY -1-1
The relrec.xpt example is represented below.
 relrec.xpt

relrec.xpt

Row

STUDYID

DOMAIN

USUBJID

IDVAR

IDVARVAL

RELTYPE

RELID

1NUTR123CE
CEREFID
ONE1
2NUTR123LB
LBREFID
MANY1

Symptom Assessments

NUT-60 - Getting issue details... STATUS Nutrition studies often provide the subject with a diary in order to provide daily information on GI symptoms (e.g., nausea, vomiting, burping, abdominal distension, flatulence, colic/cramps, regurgitation, diarrhea, constipation).

Example

In this example the subject was given a diary at Visit 1 to record their GI symptoms starting from the day after Visit 1 to the day before Visit 2. The diary was then collected at Visit 2 and a new diary given to the subject.

NUT-138 - Getting issue details... STATUS

FAEVLINT Hidden/pre-populated
-P1D
Select the diary day being entered. What is the diary day?
FATPT
Record the date the subject indicated the diary was completed.
FADAT FADTC
_________________
NAUSEA_FAOBJ FAOBJ Hidden/pre-populated
NAUSEA
Record whether the subject experienced nausea. Did the subject experience nausea?
NAUSEA_OCCUR_FAORRES FAORRES where FAOBJ = "NAUSEA" and FATESTCD = "OCCUR"
If the subject experienced nausea, complete the maximum severity over the day. If "Yes," what was the maximum severity?
NAUSEA_SEV_FAORRES FAORRES where FAOBJ = "NAUSEA" and FATESTCD = "SEV"
NAUSEA_SEV_FACOLSRT NSV.FACOLSRT where FATESTCD = "SEV" and FAOBJ = "NAUSEA" Hidden/pre-populated
MAXIMUM
FLATULENCE_FAOBJ FAOBJ Hidden/pre-populated
FLATULENCE
Record whether the subject experienced flatulence. Did the subject experience flatulence?
FLATULENCE_OCCUR_FAORRES FAORRES where FAOBJ = "FLATULENCE" and FATESTCD = "OCCUR"
If the subject experienced flatulence, complete the maximum severity over the day. If "Yes," what was the maximum severity?
FLATULENCE_SEV_FAORRES FAORRES where FAOBJ = "FLATULENCE" and FATESTCD = "SEV"
FLATULENCE_SEV_FACOLSRT NSV.FACOLSRT where FATESTCD = "SEV" and FAOBJ = "FLATULENCE" Hidden/pre-populated
MAXIMUM
BURPING_FAOBJ FAOBJ Hidden/pre-populated
BURPING
Record whether the subject experienced burping. Did the subject experience burping?
BURPING_OCCUR_FAORRES FAORRES where FAOBJ = "BURPING" and FATESTCD = "OCCUR"
If the subject experienced burping, complete the maximum severity over the day. If "Yes," what was the maximum severity?
BURPING_SEV_FAORRES FAORRES where FAOBJ = "BURPING" and FATESTCD = "SEV"
BURPING_SEV_FACOLSRT NSV.FACOLSRT where FATESTCD = "SEV" and FAOBJ = "BURPING" Hidden/pre-populated
MAXIMUM
 View CRF Metadata

Columns whose headers are shaded blue and rows whose Field ID are shaded blue contain metadata that were developed for this example annotated CRF, and are not part of the CDASH model or CDASHIG.

Observation ClassOrder Number Domain TAUG ReferenceCDASH Variable NameCDASHIG Variable Label  Question TextPromptField TypeCase Report Form Completion InstructionsInformation for SponsorsTA Specific Usage RulesSDTMIG TargetSDTM Variable Mapping Controlled Terminology CodeList NamePre-Defined ValuesValue that appears on the CRF but is not entered by the user DIsplayed QueryHidden?
Findings01FATAUG-NUT v1.0-Baseline Information on bowel movementsFAEVLINTEvaluation IntervalN/AN/AtextN/A

FAEVLINT
N/A
-P1D
hidden
Findings02FATAUG-NUT v1.0-Baseline Information on bowel movementsFATPTPlanned Time Point NameWhat is the diary day?Diary DaytextSelect the diary day being entered.

FATPT
N/ADIARY DAY 1; DIARY DAY 2; DIARY DAY 3


Findings03FATAUG-NUT v1.0-Baseline Information on bowel movementsFADATDate of CollectionWhat is the diary date?Diary DatetextRecord the date the subject indicated the diary was completed.

FADTC





Findings04FATAUG-NUT v1.0-Baseline Information on bowel movementsNAUSEA_FAOBJFinding About ObjectN/AN/AtextN/A

FAOBJ
N/A
NAUSEA
hidden
Findings05FATAUG-NUT v1.0-Baseline Information on bowel movements NAUSEA_OCCUR_FAORRESFindings About ResultDid the subject experience nausea?NauseatextRecord whether the subject experienced nausea.An example of a CDASH denormalized variable name. This name includes the components needed to map to SDTM.
FAORRES FAORRES where FAOBJ = "NAUSEA" and FATESTCD = "OCCUR"N/AYes;No


Findings06FATAUG-NUT v1.0-Baseline Information on bowel movements NAUSEA_SEV_FAORRESFindings About ResultIf "Yes," what was the maximum severity?SeveritytextIf the subject experienced nausea, complete the maximum severity over the day.An example of a CDASH denormalized variable name. This name includes the components needed to map to SDTM.

FAORRES FAORRES where FAOBJ = "NAUSEA" and FATESTCD = "SEV"N/AMild;Moderate;Severe


Findings07FATAUG-NUT v1.0-Baseline Information on bowel movements

NAUSEA_SEV_FACOLSRT

Collected Summary Result TypeN/AN/Atext
An example of a CDASH denormalized variable name. This name includes the components needed to map to SDTM.

NSV.FACOLSRT NSV.FACOLSRT where FATESTCD = "SEV" and FAOBJ = "NAUSEA"N/A
 MAXIMUM
 hidden
Findings08FATAUG-NUT v1.0-Baseline Information on bowel movementsFLATULENCE_FAOBJFinding About ObjectN/AN/AtextN/AAn example of a CDASH denormalized variable name. This name includes the components needed to map to SDTM.
FAOBJ
N/A
FLATULENCE
hidden
Findings09FATAUG-NUT v1.0-Baseline Information on bowel movements FLATULENCE_OCCUR_FAORRESFindings About ResultDid the subject experience flatulence?NauseatextRecord whether the subject experienced flatulence.An example of a CDASH denormalized variable name. This name includes the components needed to map to SDTM.

FAORRES FAORRES where FAOBJ = "FLATULENCE" and FATESTCD = "OCCUR"N/AYes;No


Findings10FATAUG-NUT v1.0-Baseline Information on bowel movements FLATULENCE_SEV_FAORRESFindings About ResultIf "Yes," what was the maximum severity?SeveritytextIf the subject experienced flatulence, complete the maximum severity over the day.An example of a CDASH denormalized variable name. This name includes the components needed to map to SDTM.

FAORRES FAORRES where FAOBJ = "FLATULENCE" and FATESTCD = "SEV"N/AMild;Moderate;Severe


Findings11FATAUG-NUT v1.0-Baseline Information on bowel movements

FLATULENCE_SEV_FACOLSRT

Collected Summary Result TypeN/AN/Atext
An example of a CDASH denormalized variable name. This name includes the components needed to map to SDTM.

NSV.FACOLSRT NSV.FACOLSRT where FATESTCD = "SEV" and FAOBJ = "FLATULENCE"N/A
 MAXIMUM
 hidden
Findings12FATAUG-NUT v1.0-Baseline Information on bowel movementsBURPING_FAOBJFinding About ObjectN/AN/AtextN/AAn example of a CDASH denormalized variable name. This name includes the components needed to map to SDTM.
FAOBJ
N/A
BURPING
hidden
Findings13FATAUG-NUT v1.0-Baseline Information on bowel movements BURPING_OCCUR_FAORRESFindings About ResultDid the subject experience burping?NauseatextRecord whether the subject experienced burping.An example of a CDASH denormalized variable name. This name includes the components needed to map to SDTM.

FAORRES where FAOBJ = "BURPING" and FATESTCD = "OCCUR"
N/AYes;No


Findings14FATAUG-NUT v1.0-Baseline Information on bowel movements BURPING_SEV_FAORRESFindings About ResultIf "Yes," what was the maximum severity?SeveritytextIf the subject experienced burping, complete the maximum severity over the day.An example of a CDASH denormalized variable name. This name includes the components needed to map to SDTM.

FAORRES where FAOBJ = "BURPING" and FATESTCD = "SEV"
N/AMild;Moderate;Severe


Findings15FATAUG-NUT v1.0-Baseline Information on bowel movements

BURPING_SEV_FACOLSRT

Collected Summary Result TypeN/AN/Atext
An example of a CDASH denormalized variable name. This name includes the components needed to map to SDTM.

NSV.FACOLSRT where FATESTCD = "SEV" and FAOBJ = "BURPING"
N/A
 MAXIMUM
 hidden
See Section 1.3, CDASH Metadata and Annotated CRFs, for explanation of annotations.

Summarizing data of the daily diaries is generally done during the analysis stage and therefore only daily records are represented below. For the purposes of this example, only the first 2 days of the diary are shown.
  • Because the diary data is not visit-related, the sponsor chose to leave VISIT and VISITNUM blank.
  • The subject was instructed to complete the diary at the end of the day (represented in FATPT); to note if they had any of the symptoms over that day (FAEVLINT used to represent that the subject was assessing the symptoms over that day); and, if yes, the severity of the symptom over that day (again, FAEVLINT used to represent that the subject was assessing the symptoms over that day).
  • Please note that sponsors should provide instructions to investigational sites/subjects on how to assess severity of symptoms (e.g., the maximum severity over the day, the most common severity over the day). In this example, the sponsor provided instructions to record the worse (maximum) severity over the day. This is represented using the NSV FACOLSRT.  NUT-47 - Getting issue details... STATUS

 face.xpt
Rows 1-4:Show the diary results for diarrhea, flatulence, and burping for the first day of the diary (Day 2 of the study).
Rows 5-9:Show the diary results for diarrhea, flatulence, and burping for the second day of the diary (Day 3 of the study).

face.xpt

Row

STUDYID

DOMAIN

USUBJID

FASEQ

FASPID

FATESTCD

FATEST

FAOBJ

FACAT

FAORRES

FASTRESC

VISITNUM

FADTC

FATPTFATPTNUMFAEVLINT
FACOLSRT
1NUTR123FANUTR123_00111OCCUROccurrence Indicator

DIARRHEA

GI SYMPTOMS

NN
2017-01-05END OF DIARY DAY 22

-P1D



2NUTR123FANUTR123_00122OCCUROccurrence IndicatorFLATULENCEGI SYMPTOMSNN
2017-01-05END OF DIARY DAY 22-P1D

3NUTR123FANUTR123_00133OCCUROccurrence IndicatorBURPINGGI SYMPTOMSYY
2017-01-05END OF DIARY DAY 22-P1D

4NUTR123FANUTR123_00143SEVSeverity/IntensityBURPINGGI SYMPTOMSMildMILD
2017-01-05END OF DIARY DAY 22-P1D
MAXIMUM
5NUTR123FANUTR123_00151OCCUROccurrence IndicatorDIARRHEAGI SYMPTOMSNN
2017-01-06END OF DIARY DAY 33-P1D

6NUTR123FANUTR123_00162OCCUROccurrence IndicatorFLATULENCEGI SYMPTOMSYY
2017-01-06END OF DIARY DAY 33-P1D

7NUTR123FANUTR123_00172SEVSeverity/IntensityFLATULENCEGI SYMPTOMSModerateMODERATE
2017-01-06END OF DIARY DAY 33-P1D
MAXIMUM
8NUTR123FANUTR123_00183OCCUROccurrence IndicatorBURPINGGI SYMPTOMSYY
2017-01-06END OF DIARY DAY 33-P1D

9NUTR123FANUTR123_00193SEVSeverity/IntensityBURPINGGI SYMPTOMSSevereSEVERE
2017-01-06END OF DIARY DAY 33-P1D
MAXIMUM

FACE NSV Metadata

Stool Sample Collection and Characteristics

Nutrition studies often require collection of stool samples for analysis. Sample handling events may also be performed on these samples (e.g., freezing the sample). Evaluations (e.g., weight, color) may also be performed on these samples.

Note: Some sponsors may choose to use a validated scale to rate attributes of a stool sample (e.g., Bristol Stool Form Scale). In this case, data would be represented following the QRS supplement. Please refer to Section 6, Questionnaires, Ratings, and Scales, of this TAUG for those scales that have been identified by the Nutrition Team as important for nutrition studies.

Samples are also sent to laboratories for additional analysis. These data are represented in the Laboratory Test Results (LB) domain. At the time of publication, there are no tests that require additional LB examples to be developed in the TAUG-Nutrition; however, the Lab Controlled Terminology team is working to determine whether additional tests may be needed. NUT-61 - Getting issue details... STATUS

Example

This example shows stool sample biospecimen events (i.e., collection, drying, freezing) NUT-62 - Getting issue details... STATUS .

 be.xpt
Rows 1, 3:Show the date and time of the stool sample collection.
Row 2:Shows the date and time of drying the stool sample.
Row 4:Shows the date and time of freezing the stool sample. The container number was represented in BEREFID to identify the sample.

be.xpt

Row

STUDYID

DOMAIN

USUBJID

BESEQ

BEREFID

BETERM

BEDECOD

VISITNUM

VISIT

VISITDY

BEDTC

BESTDTC

BEENDTC

BESTDY


BESPEC
1NUTR123BENUTR123_0011ST123CollectedCOLLECTING1BASELINE-12017-01-03T13:052017-01-03T13:05
-1
STOOL
2NUTR123BENUTR123_0012ST123DryingDRYING1BASELINE-12017-01-03T13:052017-01-03T14:45
-1
STOOL
3NUTR123BENUTR123_0021ST124CollectedCOLLECTING1BASELINE-12017-01-23T15:002017-01-03T15:00
-1
STOOL
4NUTR123BENUTR123_0022ST124FrozenFREEZING1BASELINE-12017-01-23T15:002017-01-23T17:00
-1
STOOL

BE NSV Metadata

In this example, tests were performed on the stool sample (e.g., fresh/dry weight, color, consistency). Note that for each subject in this example, LBLOBXFL=“Y”.  --LOBXFL is not a collected variable, is not inferred from VISIT and VISITNUM, and cannot be populated until after findings and exposure data are  collected.  --LOBXFL=“Y” means that, for this subject, this record was the last record with a non-missing result for this test prior to DM.RFXSTDTC (the date/time of subject's first exposure in EX). NUT-29 - Getting issue details... STATUS NUT-63 - Getting issue details... STATUS
 lb.xpt

lb.xpt

Row

STUDYID

DOMAIN

USUBJID

LBSEQ

LBREFID

LBTESTCD

LBTEST

LBCAT

LBORRES

LBORRESU

LBSTRESC

LBSTRESN

LBSTRESU

LBSPEC

LBSPCCND

LBLOBXFL

VISITNUM

VISIT

VISITDY

LBDTC

1NUTR123LBNUTR123_0011ST123SPWEIGHTSpecimen WeightSPECIMEN ASSESSMENT95g9595gSTOOLFRESHY-1Baseline-12017-01-03T13:10
2NUTR123LBNUTR123_0012ST123COLORColorSPECIMEN ASSESSMENTBrown
BROWN

STOOLFRESHY-1Baseline-12017-01-03T13:10
3NUTR123LBNUTR123_0013ST123CONSISTConsistencySPECIMEN ASSESSMENTSoft
SOFT

STOOLFRESHY-1Baseline-12017-01-03T13:10
4NUTR123LBNUTR123_0014ST123SPWEIGHTSpecimen WeightSPECIMEN ASSESSMENT20g2020gSTOOLDRIEDY-1Baseline-12017-01-03T13:10
The relrec.xpt example reflects a many-to-many dataset-level relationship between BE and LB using --REFID. NUT-64 - Getting issue details... STATUS
 relrec.xpt

relrec.xpt

Row

STUDYID

RDOMAIN

USUBJID

IDVAR

IDVARVAL

RELTYPE

RELID

1NUTR123BE
BEREFID
MANY1
2NUTR123LB
LBREFID
MANY1

Questionnaires, Ratings, and Scales

Nutrition studies may use measures that assess functional status (i.e., physical activity), descriptions of stool samples, and feeding behaviors.

Questionnaires, Ratings, and Scales (QRS) are maintained as stand-alone guides on the CDISC website at http://www.cdisc.org/foundational/qrs. Table 6.1 lists the assessments that are being pursued as potential supplements as part of the development work for TAUG-Nutrition. Supplements may or may not be finalized at the time of publication of the TAUG-Nutrition, and depend on copyright approval where applicable. CDISC cannot produce supplements for copyrighted measures without the express permission of the copyright holder.

Sponsors should refer to the link above if a measure of interest is not included below, as it may have been developed for another therapeutic area; new measures are implemented on an ongoing basis by the CDISC QRS Terminology and Standards Development sub-teams. See CDISC COP 017 (http://www.cdisc.org/bylaws-and-policies, now part of COP 001) for details on implementing or requesting development of standards for SDTM-based submissions.

Table 6.1 Identified QRS Measures of Interest to Nutrition NUT-107 - Getting issue details... STATUS

 Click here to expand...

Full Name and Abbreviation

Copyright Permission Status

Supplement Status

"Amsterdam" Stool ScaleTo be requested
King's Stool ChartTo be requested

Baby Eating Behaviour Questionnaire - Concurrent (BEBQ CONCURRENT)

Public domainSupplement in progress

Baby Eating Behaviour Questionnaire - Retrospective (BEBQ RETROSPECTIVE)

Public domainSupplement in progress
Bristol Stool Form Scale (BSFS)No response received

International Physical Activity Questionnaire - Short Last 7 Days Telephone Format (IPAQ SF PHONE VERSION)

Public domainSupplement in progress

International Physical Activity Questionnaire - Long Last 7 Days Telephone Format (IPAQ LF PHONE VERSION)

Public domainSupplement in progress

International Physical Activity Questionnaire - Short Last 7 Days Self-Administered Format (IPAQ SF SELF-ADMINISTERED VERSION)

Public domainSupplement in progress

International Physical Activity Questionnaire - Long Last 7 Days Self-Administered Format (IPAQ LF SELF-ADMINISTERED VERSION)

Public domainSupplement in progress

Appendices

Nutrition Team

Name

Institution/Organization

John Owen

CDISC

Simon Lebeau

Ividata Stats/Danone Research
Hanneke LankheetDanone Nutricia Research
Emilie BaNestlé
Sue ZhangAbbott Nutrition
Fabien FoltzerNestlé
Geraldine BaggsAbbott Nutrition
Crystal StollingsAbbott Nutrition
Elsbeth Verdonk

Danone Nutricia Research

Johan Schilt

Unilever

LuAnn HitzemannAbbott Nutrition
Jenni ReimariDupont
Stephane Auger

Danone Research

Diane WoldCDISC
Dana BoothCDISC

  

Glossary and Abbreviations

aCRFAnnotated case report form

ADaM

Analysis Data Model

CDASH

Clinical Data Acquisition Standards Harmonization Project

CDISC

Clinical Data Interchange Standards Consortium

Collected

“Collected” refers to information that is recorded and/or transmitted to the sponsor. This includes data entered by the site on CRFs/eCRFs as well as vendor data such as core lab data. This term is a synonym for “captured.”

Controlled Terminology

A finite set of values that represent the only allowed values for a data item. These values may be codes, text, or numeric. A codelist is one type of controlled terminology.

CRF

Case report form (sometimes called a case record form). A printed, optical, or electronic document designed to record all required information to be reported to the sponsor for each trial subject.

Domain

A collection of observations with a topic-specific commonality about a subject.

eCRF

Electronic case report form

GGGGlobal Governance Group

NCI

National Cancer Institute

NSVNon-standard variable

Patient

A recipient of medical treatment

SDS

Submission Data Standards. Also the name of the team that maintains the SDTM and SDTMIG.

SDTM

Study Data Tabulation Model

SDTMIG

SDTM Implementation Guide for Human Clinical Trials

SDTMIG-PGxSDTM Implementation Guide for Pharmacogenomics/Genetics

Subject

A participant in a study

TAUGTherapeutic area user guide
TAUG-NutritionTherapeutic Area Data Standards User Guide for Nutritional Research

Non-Standard Variables

The following table lists the non-standard variables used in this document, and gives their parent domain and variable-level metadata.

Parent DomainVariableLabelSAS Data TypeDefine-XML Data TypeCodelist/Controlled TermsRoleDescriptionNotes

FA, LB

--COLSRTCollected Summary Result TypeChartext
Non-Standard Variable Qualifier of --ORRESVariable qualifier of --TESTCD and --TEST. Used to indicate the type of collected summary result (e.g., MAXIMUM, MINIMUM, MEAN, MEDIAN, NADIR). This includes source summary results collected on a CRF or provided by an external vendor (e.g., central lab). If the summary result is derived using individual source data records, this summary result should be represented in ADaM. If a sponsor has both a collected summary result and a derived summary result, the collected summary result should be represented in SDTM and the derived summary result should be represented in ADaM.

FA, LB

--SOURCE NUT-103 - Getting issue details... STATUS Source of DataChartext
Non-Standard Record QualifierThe original source of the data such as RECALL, MEDICAL RECORD, CENTRAL LAB. This should not be confused with EVAL which describes the role of the person who provided the evaluation.
BE--SPECSpecimen TypeChartextSPECTYPENon-Standard Record Qualifier of --TESTCDDefines the type of specimen used for a measurement. Examples: SPUTUM, BLOOD, PUS.
EX--NADEVINumber of Administrations in Eval. Int.Numinteger
Non-Standard Record QualifierThe number of times the treatment was administered within a specific evaluation interval.
(Parenthesis indicates CDISC/NCI codelist)

References

Works Cited

  1. World Medical Association. Declaration of Helsinki—ethical principles for medical research involving human subjects. https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/. Published March 29, 2017. Accessed March 8, 2018.
  2. ICH. Efficacy guidelines: E6 good clinical practice. http://www.ich.org/products/guidelines/efficacy/article/efficacy-guidelines.html#6-2. Published November 9, 2016. Accessed March 8, 2018.
  3. World Health Organization. The World Health Organization's infant feeding recommendation.http://www.who.int/nutrition/topics/infantfeeding_recommendation/en/. Accessed March 8, 2018.

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.

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