Therapeutic Area.

The TA is an area of medical practice that encompasses groupings of specific diseases and/or disorders generally treated by a specific medical specialty, such as oncology, cardiovascular, neurology or hematology.

CRFs

Case Report Forms.

CRFs used to capture clinical trial data rely on linkages between and among concepts. CRFs also frequently contain logic, such as which values are allowed for a given field, when one field is a value calculated from other fields, and when some fields are not relevant based on an answer to another field.

National Cancer Institute (NCI) Enterprise Vocabulary Services.

EVS provides terminology content, tools, and services to meet the needs of NCI and the biomedical research community.

Subject Matter Experts.

 SME is a person who possesses a deep understanding of a particular subject.

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.

Analysis Data Model. 

ADaM defines dataset and metadata standards that support: efficient generation, replication, and review of clinical trial statistical analyses, 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).

1. Verify that all applicable regulations are taken into account in the standard under development and that such regulatory documents are referenced in the appendix of the standards document.

2. Prepares the scoping package for submission.

3. Posts it in the team space on the CDISC Wiki once the Project Charter is approved.

1. Ensure applicable regulatory guidance and requirements are taken into account.

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

2. Completes the literature review for the therapeutic area and works with the Project Manager and the ADaM Representative to compile a reference list.

1. Performs an initial gap analysis against CDISC CT to identify concepts that exist in CDISC standards for each mapped concept
2. Inputs the code list name, code list NCIt c-code reference, CDISC submission value, and submission value NCIt c-code reference onto the Concept Listing Spreadsheet for each mapped concept
3. Provides comments on concepts to include where a term may be mapped within the CDISC model, issues regarding term granularity, valid value sets, etc. 

1. Reviews the output of the initial scoping stage and identifies potential areas that will require new constructs in ADaM
2. Holds ADaM assessment meeting if applicable.

1. Receives Project Charter(TAs) for approval to proceed with Stage 1.

Gathers CRFs, perform a Public Database Search for existing TA Concepts.

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

EVS Terminology Expert

Submit scoping package to TAPSC/TLC and plans kick-off activities.

Receives Project Charters(TAs) for approval to proceed with the next stage of the development process.

Posts Project Charter in the team space on the CDISC Wiki.