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Project Charter
Template v2 January 23, 2015
Name of Project: Rheumatoid Arthritis Therapeutic Area Data Standards
July 2, 2015
Project Manager: Trisha Simpson
1. Scope of Rheumatoid Arthritis Therapeutic Area Project v1.0
1.1. Project Description
The rheumatoid arthritis (RA) 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
The disease state is characterized by chronic, symmetric, and progressive inflammation in the joints resulting in
painful deformity and immobility, especially in the fingers, wrists, feet, and ankles.
1.3. Type of Studies
Types of studies include outpatient clinical trials in Phases 1-4 for therapies under investigation for treatment of RA.
1.4. Focus Population
The population in scope is adult patients (aged 18 and older) with RA.
1.5. Specific Indications
There are no specific indications in addition to RA that are in scope for this project.
1.6. Proposed Scope
The project is scoped to achieve its deliverables within a time frame of 10 months as agreed by CFAST. The team
will develop a document that will include: disease specific concept maps, SDTM-IG type examples (to potentially
be developed within SHARE as a pilot) and metadata, controlled terminology, CDASH annotated CRFs, CDASH
metadata examples, and ADaM examples. Research concepts that are most relevant in RA clinical trials will be
described in the document. Those concepts not determined to be modeled elsewhere in previous publications will be
modeled.
Type of Data
Magnitude
Gap Analysis
Subject and Disease
Characteristics
Disease History
Low
Comorbidities
Low
Family History
Low
Disease History will be textually described as
it relates to RA, but will not be modeled as
this concept is adequately detailed in the
foundational standards.
Comorbidities, such as cardiovascular disease
and malignancies, will be textually described
as they relate to RA, but not be modeled as
this concept is adequately detailed in the
foundational standards.
Family History, such as cardiovascular
disease and malignancies, will be textually
described as they relate to RA, but not be
modeled as this concept is adequately detailed
in the foundational standards.
Disease Assessments
Laboratory Tests
Low
Approximately 12 laboratory parameters were
noted during the scoping phase. These will be
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Questionnaires, Ratings and Scales
(QRS)
Swollen Joint Count/Tender Joint
Count
Medium
Adverse Events of Special Interest
Low
Adjudication of AEs
Low
Radiographic & Imaging
Assessments
High
High
Routine Data
Concomitant Medications
Medium
Device Malfunctions & Data
Medium
listed in the RA TAUG. Three of the
parameters (Anti-Cyclic Citrullinated Peptide
and Anti-Nuclear Antibody, and Synovial
Fluid Cell Count) will be modeled in an
SDTM dataset example in the TAUG.
The team has identified 28 instruments of
interest that will be listed in the RA TAUG.
Swollen Joint Count and Tender Joint Count
will be fully modeled with CDASH and
SDTM examples provided. The group is
currently considering the use of the new MK
(Musculoskeletal) domain.
AEs of special interest for RA, such as
infections (including tuberculosis),
malignancies, and major adverse cardiac
events (MACE), textually described as it
relates to RA, but will not be modeled as this
concept is adequately detailed in the
foundational standards. Additional data
points will be assessed as we finalize the gap
analysis and List of Concepts during Stage 1
of the development process.
Considerations for adjudication of AEs will be
textually described but will not be modeled in
the RA TA as this concept will be discussed
across the TAs in order to address the concept
consistently.
Radiographic Assessments and Response will
be fully modeled with CDASH and SDTM
examples provided.
Medications commonly used to treat RA will
be described in the RA TAUG. Documenting
history of use will be addressed, including
dose, frequency, route of administration,
duration, and treatment response (lack of
efficacy, loss of efficacy, intolerance/toxicity,
etc.). Additional data points will be assessed
as we finalize the gap analysis and List of
Concepts during Stage 1 of the development
process. New Controlled Terminology may be
requested for grouping medications used to
treat RA and a new codelist for use with the
draft variable –RSDISC.
Device Malfunction data will be textually
described as it relates to RA, but will not be
modeled as this concept is adequately detailed
in the Device standard. Device-related AE
data will be modeled in CDASH and SDTM.
The group will consider the proposed
structure currently under discussions in the
AE SDTM sub-team. It is our understanding
the structure is not yet approved.
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Healthcare Resource Utilization
Low
Healthcare Resource Utilization will not be
modeled since this is adequately detailed in
the foundational standards.
Data Analysis
Statistical endpoints
High
Illustration of intermediate dataset(s) to take
individual scores and create a BDS compliant
composite score analysis dataset. Issues
related to missing data imputation will be
explored. Analytical issues relating to QRS
controlled terminology will be investigated.
1.7. Project Deliverables
Therapeutic Area Standards User Guide (TAUG) that will include:
 Essential core research concepts with definitions, data types, 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:
o Identification of the data needed for endpoint derivations, but not the actual statistical analyses of
endpoints.
o Description of how the clinical endpoints translate into statistical endpoints.
o Examples of ADaM compliant analysis datasets.
o If warranted, example table shells/figures and illustrations of analysis results metadata.
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
Timeline
Stage 0
Scoping & Planning
June 2015
Stage 1
Concept Modeling
August 2015
Stage 2
Standards Development
October 2015
Stage 3a
Internal Review
December 2015
Stage 3b
Public Review
February 2016
Stage 3c
Publication
April 2016
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)
• Major potential risks: (describe any potential risks to the project and mitigation plans)…
For this project to succeed on a 10-month timeline, assigned resources must be available to work on project
deliverables. It is critical that personnel assigned are able to prioritize the project regardless of the organization
providing the resource.
• Project Complexity: Low/Medium
All relevant concepts will be described in the TAUG as they relate to RA but many are covered elsewhere in
previously published TAUGs or other existing standards.
• Significant Project Challenges: Low
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1.10. Project Document Repository
Project documents will be maintained in the CDISC portal under Teams Projects > Therapeutic Disease Specialty >
Rheumatoid Arthritis and will be accessible to all team members. The TAUG will be developed and published
through the CDISC WIKI.
1.11. Plans for Future Versions
A future version is planned to include pediatric patient populations.
2. Resources
2.1. Team Members
Project Team members fall into twelve 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.
Number of
Active Team Members by Role
Participants
 Project Manager
1
 Clinical Therapeutic Area Experts
3
 Medical Writer
1
 Statisticians
4
 Statistical Programmers
3
 Metadata Developers
3
 CDASH Representatives
6
 ADaM Representatives
6
 SDS Representatives
3
 Terminology/Clinical Outcome Assessments Representatives
3
25
Total
Team members currently identified are listed in a separate spreadsheet to accommodate changes over time. The RA
team member list will be maintained in the project document repository on the CDISC Portal.
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
CFAST Therapeutic Area Standards Steering
Committee
CDISC
TransCelerate BioPharma
FDA
NCI EVS
CDISC Teams: CDASH, SDS, Terminology and
ADaM
Role
Program governance and resource allocation.
Program and project managment, team members and expert
consultants (includes both CDISC employees and volunteers).
Provides project management, clinical expertise, team
members and reviewers
Performs review of draft and final documents to ensure data
points meet FDA reviewer needs.
Provides team members and consultants to support controlled
terminology development.
Project liaisons to support the TA standards development
resources.
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2.3. Literature Review and References
References consulted include relevant ACR/EULAR, OMERACT, FDA, and EMEA guidances. Team members
contributed and reviewed reference articles. A complete list of relevant guidances, articles and publications for
this indication can be found on the CDISC RA team portal.
3.
Relevant Project Documents
Related documents to this RA Project Charter are:
 RA Team Member List (to be updated as required throughout the project)
 RA Concept Listing Spreadsheet
 RA Scoping & Planning Checklist
 RA Project Plan
4.
Date of TAPSC Approval:
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