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Information collected is summarized in the Project Charter (TAs) that is submitted to the Team Leads/TAPSC for approval to proceed with the next stage of the development process.
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| Term | Definition |
|---|---|
| TA | 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. |
| TAPSC | Therapeutic Area Standards Program Steering Committee. |
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. |
| EVS | 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. |
| SMEs | Subject Matter Experts. SME is the person who possesses a deep understanding of a particular subject. |
| TLC | 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. |
| ADaM | 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). |
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| Step # | Role | Instructions |
|---|---|---|
| 1.0 | EVS Terminology Expert / Clinical TA Expert (s) | Gathers CRFs, perform a Public Database Search for existing TA Concepts. |
| 2.0 | Project Team | Ensure applicable regulatory guidance and requirements are taken into account. |
| 2.1 | Clinical TA Expert(s)/Project Manager | Verifies that all applicable regulations applicable regulatory guidance are taken into account in the standard under development and that such regulatory documents are referenced in the appendix of the standards document. |
| 3.0 | Clinical TA Expert(s) | Identifies the appropriate core concepts and that the standards under development are aligned with current medical practice and thinking. |
| 4.0 | Project Manager | Review scoping materials. |
| 5.0 | EVS Terminology Expert | Performs Controlled Terminology Gap Analysis. |
| 6.0 | ADaM SME | Holds ADaM assessment meeting if applicable. |
| 7.0 | Project Manager | Draft project charter and project plan. |
| 8.0 | Project Manager | Review the entire scope package with the Data Science representative including the expected required Wiki structures. |
| 9.0 | Project Manager | Submit scoping package to TAPSC/TLC and plans kick-off activities. |
| 10.0 | TAPSC/TLC | Receives Project Charters(TAs) for approval to proceed with the next stage of the development process. |
| 11.0 | Project Manager | Posts Project Charter in the team space on the CDISC Wiki. |
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References
List references pertinent to this Work Instruction, e.g., COP-001.
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