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News and updates

  • NEW 2020-02-14: Initial version

General

CDISC published Version 1.2 of the ADaM Implementation Guide (ADaMIG v1.2) on October 3, 2019.

For full details about ADaMIG v1.2 visit ADaM foundational standard on CDISC website or ADaMIG on CDISC Wiki.

Metadata for ADaMIG v1.2 includes:

  • Data structure information for the ADaM Subject-Level Analysis Data Structure (ADSL) and Basic Data Structure (BDS).
  • Variable set metadata. Variable sets reflect the metadata tables provided in the IG document. There are 9 variables sets for ADSL and 15 for BDS.
  • Variable metadata. Variable level details from the IG. The IG metadata tables include columns for the Variable Name, Variable Label, Type, Codelist/Controlled Terms, Core, and CDISC Notes.

There are three ways to access the ADaM Content in the CDISC Library:

  1. Using the API.
  2. Using the Data Standards Browser.
  3. Downloads from the CDISC Library Archive.

Using the CDISC Library API

The CDISC LIbrary API provides users (programmers, EDC developers, et al.) with access to the metadata repository contents to facilitate use of standard metadata within software applications.

There are generic API query templates for requesting ADaMIG v1.2 metadata:

/mdr/adam/adamig-1-2/datastructures
/mdr/adam/adamig-1-2/datastructures/{datastructure}
/mdr/adam/adamig-1-2/datastructures/{datastructure}/varsets
/mdr/adam/adamig-1-2/datastructures/{datastructure}/varsets/{varset}
/mdr/adam/adamig-1-2/datastructures/{datastructure}/variables/
/mdr/adam/adamig-1-2/datastructures/{datastructure}/variables/{var}

The API can return the metadata content as either JSON or XML. A CDISC Library account is required.

Using the CDISC Library Data Standards Browser

The Data Standards Browser provides an interactive environment for viewing the contents of the CDISC Library.

A CDISC Library account is is required.

CDISC Library Archives

CDISC member users may obtain snapshots of metadata from CDISC Library Archives on CDISC website. A CDISC member account is required.

Known Issues & Changes from ADaMIG v1.1

  1. In ADaMIG v1.2 the identifiers for the variable sets do not include the data structure name as a prefix.

  2. In ADaMIG v1.2 no variable sets include a description.

FAQ

 How is controlled terminology represented in the CDISC LIbrary?

In the IG document, the Codelist/Controlled Terms column in the metadata tables lists either the name of a CDISC Controlled Terminology in parentheses (e.g. (DTYPE) or a list of acceptable code values (e.g. Y, N).

For Variables that use a CDISC Controlled Terminology codelist, the variable metadata returned by the API includes a link to the controlled terminology definition in the library. In the Data Standards Browser, the C-code for the published codelist will appear in the Code column.

For variables where the metadata table shows a list of allowable values, the variable metadata returned by the API includes the list of allowable values. In the Data Standards Browser, the Code column will be empty. See Limitations (Staging).

In the Excel workbook export, the Codelist/Controlled Terms column displays either the name of the Controlled Terminology or the allowable values.

 How does the content in CDISC Library relate to the content in the IG?

The CDISC Library content was extracted from the ADaMIG on CDISC Wiki and loaded directly into the metadata repository that underlies the metadata repository.

 Can Examples and Rules be loaded into CDISC Library?

CDISC is exploring options for adding metadata for examples, rules, and other informative content in the future.

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