This internal clinical check of concepts and concept maps is a targeted review by the Clinical Expert and other Clinical SMEs. The purpose of the review is to ensure the core concepts under development are adequate and appropriate, and that there are no significant concepts missing. This review limited to the team members, SMEs, FDA and other identified stakeholders.
Metadata Developers Forum and Concept Modelers Forum
- Teams are expected to take any examples about which they have questions to the appropriate forum.
- Results of discussions at the forum should be recorded in the forum’s Wiki space. Documentation must include rationales for decisions and labels, including label for the project (e.g., which TA).
- Terminology decisions are currently documented on Terminology pages within the Wiki TA projects and in Terminology team spreadsheets in the portal
Comment Submission
Comments are submitted using the CDISC JIRA issue tracker. The duration of the check of concepts review period is approximately two weeks; it can be extended by the Project Manager, if necessary. After the review, the team refines the concept maps and list of concepts as necessary. At the conclusion of Stage 1, the Project Manager updates the project plan and project charter, and notifies all parties involved.