CDISC invites you to submit comments on the draft version 1.0 of the Analysis Data Model (ADaM) Examples of Traceability during Public Review.
Section 2.2 of ADaMIG v1.2 states: To assist review, ADaM datasets and metadata must clearly communicate how the ADaM datasets were created. The verification of derivations in an ADaM dataset requires having at hand the input data used to create the ADaM dataset. A CDISC-conformant submission includes both SDTM and ADaM datasets; therefore, it follows that the relationship between SDTM and ADaM must be clear. This requirement highlights the importance of traceability between the analyzed data (ADaM) and its input data (SDTM).
Traceability is built by clearly establishing the path between an element and its immediate predecessor. The full path is traced by going from one element to its predecessors, then on to their predecessors, and so on, back to the SDTM datasets, and ultimately to the data collection instrument.
The objective of this document is to provide examples of traceability using ADaM. Please refer to ADaM v2.1 , ADaMIG v1.2 and the ADaM OCCDS v1.0 for required background about ADaM and ADaM data structures.
To Provide Comments
- View the draft: ADaM Examples of Traceability.
- Instructions for providing comments: Instructions for Reviewers
You will need to log in or register for the CDISC Wiki to provide comments.
- Register for the Wiki. If you already have an account on Wiki or JIRA, our issue-tracking system, simply log in to your account; Wiki and JIRA use the same login credentials. CDISC Wiki is a different login from www.cdisc.org.
Public review is a key quality step in our Standards Development Process. CDISC relies on your input to ensure neutral, consensus-based data standards are developed and adopted by a diverse global community interested in improving research processes and quality for the benefit of all.
Thank you for contributing your time and expertise.