CRFs

TAPSC

Analysis Data Model.  ADaM defines dataset and metadata standards that support: efficient generation, replication, and review of clinical trial statistical analyses, an and traceability among analysis results, analysis data, and data represented in the Study Data Tabulation Model (SDTM).​

ADaM is one of the required standards for data submission to FDA (U.S.) and PMDA (Japan).

Prepares the scoping package for submission.

Once the Project Charter is approved, the Project Manager posts it in the team space on the CDISC Wiki.

1. Leads one or more TA projects
2. Manages projects by coordinating sub-teams, schedules, and deliverables according to the 10-12 month development timeline
3. Ensures effective team interactions and overall project communication
4. Collaborates with Education Representative to develop TA education materials, or assigns a TA team member, and coordinates team review of draft and final training materials

Ensures the appropriate core concepts are identified and that the standards under development are aligned with current medical practice and thinking.

Completes the literature review for the therapeutic area and

works with the Project Manager and the ADaM Representative to compile a reference list.

1. Functions as the Subject Matter Expert (SME) for therapeutic area concepts, clinical endpoints and terminology
2. Facilitates consolidation of clinical data elements and terms
3. Responsible for the medical content of TA User Guides by writing, and sometimes reviewing sections of data standards that require clinical expertise, with the Medical Writer
4. Reviews and assists in the search of medical literature and regulatory guidance to ensure appropriate references are included, cited and followed, as needed
5. Ensures examples in the TA guide are appropriate and clinically accurate, ensures the draft standard is understandable for the implementation community
6. Assists team as needed to resolve comments
7. Collaborates on the development and review of TA education materials to ensure accuracy and completeness

1. Performs inputs process, checking existing CDISC CT, NCIt, caDSR, and Mesh
2. Builds and reviews initial list of inputs produced with the team
3. Oversees initial gap assessment against existing terminology
4. Identifies relevant TA clinical core concepts with Program & Project Managers
5. Works with Terminology Team to develop needed new terms within the project timeline
6. Collaborates on development and review of TA education materials to ensure accuracy and completeness

Gathers CRFs.

Review public databases, regulatory guidelines.

Refine scope.

Identify network for clinical SMEs.

Clinical TA Expert(s) / EVS Terminology Expert / Statistical Analysis Expert

Submit scoping package to TAPSC/TLC.

Plans kick-off activities.