Adaptive follow-up, safety and data integrity

Protect monitoring integrity and participants

Arm closure or early stopping does not automatically end participant follow-up. Keep interim access, data cutoffs, safety review and final data release responsibilities explicit.

Flow diagram

Adaptive follow-up, safety and data integrityF1.S1Maintain outcome follow-upF1.S2Define safety review pathsF1.S3Control interim data accessF1.S4Resolve queries before decisioncutoffsF1.S5Finalize populations and audittrailF1.N1Interim data governanceData cutRequiredinformationAccess groupQuality reviewVersionInterim reviewSafety reviewFinal analysisF1.N2Assumptions and rationaleF1.N3Method and protocol evidenceF1.S0 Start flowAdaptive follow-up, safety and dataintegrityF1.S999 End flowEnd flow

Steps

Maintain outcome follow-up

Preserve assessments for all relevant participants across adaptation epochs.

Define safety review paths

Separate urgent participant safety actions from efficacy adaptation decisions.

Control interim data access

Document data cutoffs, blinding, secure transfers and reviewer permissions.

Resolve queries before decision cutoffs

Version data extracts and distinguish provisional from final outcomes.

Finalize populations and audit trail

Retain rule epochs, decisions and deviations for final analysis.

Adaptive follow-up, safety and data integrity

End flow

Tables and supporting information

Interim data governance

Interim data governanceData cutRequiredinformationAccess groupQuality reviewVersionInterim reviewSafety reviewFinal analysis

Do not expose unblinded interim information to inappropriate trial roles.

Assumptions and rationale

Changes in recruitment or assessment after leaked interim information can introduce operational bias.

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.

Sources