Name of Project: <<indication>> Therapeutic Area Data Standards
Project Manager:
Date Drafted: <<Month Date, Year>>
Date of TAPSC Approval: <<Month Date, Year>>
1 Scope of <<indication>> Therapeutic Area Project
1.1 Project Description
The <<indication>> therapeutic area standards project is being performed under the CFAST initiative to accelerate clinical research and medical product development by facilitating the creation and maintenance of data standards, tools, and methods for conducting research in therapeutic areas important to public health.
1.2 Disease Characteristics
1.3 Type of Studies
1.4 Focus Population
- Adult
- Pediatric
- Other ________________
1.5 Specific Indications
1.6 Proposed Scope
The project is scoped to achieve its deliverables within a time frame of 10 months as agreed by CFAST. (Continue the description for this particular project here. An example of a completed version of the table below is available)
| Type of Data | Gap Analysis (to existing standards) | Magnitude (estimated level of effort - high, medium, low) |
|---|---|---|
1.7 Project Deliverables
Therapeutic Area Standards User Guide that will include:
- Essential core research concepts with definitions, data types (simple & ISO 21090) and SDTM mappings
- Concept maps of disease area research concepts
- CDASH metadata for selected research concepts
- Selected annotated CRFs (with CDASH and SDTM-based annotations)
- SDTM examples, as appropriate
- Minimum terminology value sets (code lists) with definitions and C-Codes, as appropriate
- Analysis guidelines:
- Identification of the data needed for endpoint derivations, but not the actual statistical analyses of endpoints.
- Description of how the clinical endpoints translate into statistical endpoints.
- Examples of ADaM compliant analysis datasets.
- Selected example table shells/figures and illustrations (via analysis results metadata) of the crosswalk from the ADaM dataset(s) to the analysis.
Project deliverables will reference sources and describe provenance used in their creation.
1.8 Project Milestones
The project will follow the enhanced therapeutic area standards development process.
High-level project plan:
| Project Stage | Project Stage Description | Month of Stage End |
|---|---|---|
| Stage 0 | Scoping & Planning | |
| Stage 1 | Concept Modeling | |
| Stage 2 | Standards Development | |
| Stage 3a | Internal Review | |
| Stage 3b | Public Review | |
| Stage 3c | Publication |
More detailed dates and milestones will be maintained in a separate project plan on the CDISC portal.
1.9 Complexity Assessment (Gaps, Risks, Complexities and Challenges)
(Based on the initial scoping and magnitude assessment, assign a complexity rating of high, medium, or low to the project. Provide a rationale for this comment. An example of a completed version of this section is available.)
- Major potential risks: (describe any potential risks to the project and mitigation plans)…(Example: For this project to succeed, assigned resources must continue be made available to work on project deliverables. It is critical that personnel assigned are able to prioritize the project above other responsibilities regardless of the organization providing the resource.)
- Project Complexity: (categorize as high/medium/low and provide an explanation)…
- Significant Project Challenges: (describe what project challenges were encountered and explain consequences)…
1.10 Project Documentary Repository
Project documents will be maintained in the CDISC Wiki and will be accessible to all team members.
1.11 Plans for Future Versions
(If some aspects of the TA (e.g., some patient populations) or some aspects of the standards (e.g., ADaM examples) will be addressed in a later version of the TA standard, provide information on proposed content of later versions. Note that a next version may be a v1.1 in many cases, especially those when converting a provisional* to a final without adding new content.)
(* A provisional version is an otherwise final version but which contains guidance and/or examples for draft domains and/or other models that are not yet final.)
2 Resources
2.1 Team Members
Project Team members fall into five roles with different responsibilities. Members in project level roles are recruited for the particular therapeutic area project. Not listed below are program level resources that support all TA projects. Reviewers are not listed as these evolve over the life of the project.
| Active Team Members by Role | Number of Participants |
|---|---|
| Project Manager | |
| Clinical TA Experts | |
| Medical Writer | |
| Statisticians | |
| Metadata Developers | |
| CDASH Representatives | |
| ADaM Representatives | |
| SDS Representatives | |
| Terminology/QRS Representatives | |
| Total |
Team members currently identified are listed in a separate spreadsheet to accommodate changes over time. The <<indication>> team member list will be maintained in the project document repository.
2.2 Key Sponsors and Participants
Current key participants are shown below. The project also intends to invite participation of relevant medical associations. Other key participants will be added as they are identified.
| Stakeholder/Participant | Role (Modify the contents of this column from the generic provided to accurately reflect which roles are provided by which participant for this particular project.) |
|---|---|
| CFAST TA Standards Steering Committee | Program governance and resource allocation. |
| CDISC | Program and project managment, team members and expert consultants (includes both CDISC employees and volunteers). |
| C-Path | Program and project managment, team members and expert consultants |
| TransCelerate BioPharma | Provides project management, clinical expertise, team members and reviewers |
| FDA | Performs review of draft and final documents to ensure data points meet FDA reviewer needs. |
NCI EVS | Provides team members and consultants to support controlled terminology development. |
| CDISC Teams: CDASH, SDS, Terminology, ADaM | Project liaisons to support the TA standards development resources. |
| BRIDG Semantic Coordination Committee | If new semantics are needed, the BRIDG SCC will be consulted and will assess if and how new semantics will be incorporated in the model. |
2.3 Literature Review and References
(Example: References consulted include relevant NIH, FDA and EMEA guidance, literature and CDEs. A complete list of relevant guidances, articles and publications for this indication can be found on the CDISC team portals.)
3 Relevant Project Documents
Related documents to this Project Charter are:
- Team Member List (to be updated as required throughout the project)
- Concept Listing Spreadsheet
- Scoping & Planning Checklist
- Project Plan