Dose-finding eligibility and cohort enrollment

Track evaluability and replacement rules

Evaluable participants are a subset of enrolled participants, not a disjoint group. Specify replacement and hold rules, and retain safety information from people who do not complete the formal evaluation window.

Flow diagram

Dose-finding eligibility and cohort enrollmentF1.S1Define eligible participantsF1.S2Define evaluability and replacementF1.S3Enroll a cohort under current rulesF1.S4Track enrollment holdsF1.S5Record participant dispositionF1.S6Enrolled participantsF1.S7Evaluable participantsF1.N1Dose-finding enrollment rulesElementDefinitionTimingAuthorityRationaleEligibilityEvaluabilityReplacementEnrollment holdF1.N2Assumptions and rationaleF1.N3Method and protocol evidenceF1.S0 Start flowDose-finding eligibility and cohortenrollmentF1.S999 End flowEnd flow

Steps

Define eligible participants

Specify population, prior therapies and safety-related eligibility.

Define evaluability and replacement

Record toxicity-window evaluability and replacement reasons prospectively.

Enroll a cohort under current rules

Specify cohort size as a study input and the authorized dose level.

Track enrollment holds

Document pending assessments, safety holds and staggered enrollment.

Record participant disposition

Keep enrolled, treated, evaluable and replaced participants distinct.

Enrolled participants

Record people using the documented inclusion definition. This count is not a disjoint partition of the other count nodes.

Evaluable participants

Record people using the documented inclusion definition. This count is not a disjoint partition of the other count nodes.

Dose-finding eligibility and cohort enrollment

End flow

Tables and supporting information

Dose-finding enrollment rules

Dose-finding enrollment rulesElementDefinitionTimingAuthorityRationaleEligibilityEvaluabilityReplacementEnrollment hold

No cohort size or dose is recommended by this template.

Assumptions and rationale

Replacement must not erase safety information from participants who received treatment.

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