Clinical Trial Data Monitoring Committee Charter Form
Use this form to define the Data Monitoring Committee charter for a clinical trial, including study details, committee roles, review procedures, decision criteria, confidentiality, reporting, and approval.
Study Identification
Study Title
*
Protocol Number or Study Code
*
Sponsor or Organization Name
*
Indication or Therapeutic Area
*
Trial Phase
*
Please Select
Phase I
Phase II
Phase III
Phase IV
Other
Study Start Date
*
 -
Month
 -
Day
Year
2 digit month, 2 digit day, 4 digit year
Date
DMC Membership and Roles
Committee Chair Name
*
Committee Chair Role
*
Statistician, Medical Expert, and Additional Member Details
*
Additional Member Names/Roles
Statistician
Medical Expert
Additional Member
Other
Include External Independent Members?
*
Yes
No
Meeting and Review Schedule
Planned meeting frequency
*
Monthly
Quarterly
Ad hoc
Other
First review meeting date
*
 -
Month
 -
Day
Year
2 digit month, 2 digit day, 4 digit year
Date
Meeting format
*
Virtual
In-person
Hybrid
Expected review duration per meeting (hours)
Data Review Scope and Materials
Data domains to review
*
Safety
Efficacy
Enrollment
Protocol deviations
Interim analyses
Other
Source documents and reports required for each meeting
*
Access expectation for committee data review
*
Blinded only
Unblinded only
Both blinded and unblinded
Other
Data cut-off process description
*
Stopping Rules and Decision Criteria
Predefined stopping criteria for safety or futility
*
Continuation criteria
*
Decision-making method
*
Consensus
Majority vote
Chair decision
Other
Escalation path for urgent findings
*
Confidentiality, Independence, and Conflict Management
Do any committee members have a conflict of interest to disclose?
*
Yes
No
If yes, provide disclosure details
Rules for access to unblinded data and sponsor communications
*
Reporting and Communication
Report Recipients
*
Sponsor
Steering Committee
Investigator Team
Regulatory Team
Data Management Team
Other
Reporting Timeline After Each Meeting (Days)
*
Format of Recommendations
*
Written Report
Email Summary
Formal Letter
Presentation Slides
Other
Documentation Retention / Archive Location
Charter Approval
Approval Date
*
 -
Month
 -
Day
Year
2 digit month, 2 digit day, 4 digit year
Date
Approved By (Name and Role)
*
Effective Date
*
 -
Month
 -
Day
Year
2 digit month, 2 digit day, 4 digit year
Date
Version Number
*
Final Remarks or Exceptions
Submit Charter
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