Page History

Technical Leadership Committee

The TLC is made up of Foundational Standards Team Leads. This committee discusses issues pertaining to the Foundational Standards. The TLC also develops the agenda for CDISC IntraChanges and typically leads sessions during these events.

QRS

1. Assembles project team
2. Sign up for the GGG review using GGG Signup sheet
3. Submits all examples to the Global Governance Group (GGG) for approval
4. Updates the project plan and project charter, and notifies all parties involved. Performs CDISC project review

1. Coordinates development of draft and final training materials with Project Managers
2. Orients the Project Team to the Education Team training development process and Presentation Templates
3. Supports the foundational education sub-team leads with process, tools and templates

1. Creates and maintain on-line and classroom courses
2. Oversee the qualification of new instructors. Helps identify instructors to teach specific courses

1. Sets Up standard space in the wiki

1. Performs inputs process, checking existing Questionnaires, Rating and Scales Supplements
2. Reviews initial list of inputs produced with the team
3. Ensures questionnaires are mapped to SDTM
4. Works with Terminology Team to develop needed new terms
5. Develops QRS supplements, as appropriate
6. Checks copyright restrictions and resolves them, if possible

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

1. Completes the gap analysis on SDTM mappings
2. Ensures proposed standards are aligned with SDTM
3. Works with the Project Team to address areas not covered by the current SDTMIG

1. Receives, reviews, gives feedback, and approve modeling examples
2.  Approves the modeling before the team can move to Stage 2

1. Models concepts and creates concept maps
2. Defines any concepts that have not been addressed in current CDISC standards to reach a common understanding with the Clinical Expert
3. Refines deliverable plan

Assembles project team

Conducts an initial meeting to orient the Project Manager and team on training development procedures and templates. 

Submits all examples to the Global Governance Group (GGG) for approval.