Platform interim decisions and governance
Prespecify adaptations and review responsibilities
Separate arm-entry decisions, safety monitoring and efficacy review with documented authority. Protect interim information across participating teams and retain a master and arm-specific audit trail.
Flow diagram
Steps
Define governance and review roles
Separate master-protocol oversight, arm decisions and operational implementation.
Specify comparison-specific monitoring
Record information times and efficacy, futility and safety rules.
Define arm-entry and closure actions
Link permissible actions to protocol versions and review authority.
Protect interim information
Control unblinded access and consider information shared across arms.
Maintain decision audit trail
Record evidence, approvals, epoch transitions and participant communication requirements.
Platform interim decisions and governance
End flow
Tables and supporting information
Platform decision register
Boundaries and authorities remain blank until defined by the protocol.
Assumptions and rationale
Shared operations and information can link otherwise distinct comparisons; governance must preserve trial integrity.
Method and protocol evidence
Attach the protocol, methodological sources and versioned software specification supporting these decisions. Record citations and provenance; do not enter participant identifiers.