Deviation or Violation?
A research blood draw is completed one day outside the allowed visit window, but participant safety and study data are not affected.
What is a protocol deviation?
During protocol drafting, no visit windows are included for required study visits, causing repeated out-of-window visits after activation.
What is poor operational feasibility planning?
Repeated missed safety labs continue occurring even after retraining and implementation of a CAPA plan.
What is Continuing Noncompliance (CNC)?
This meeting includes PD, CRCs, OCTA, compliance, statisticians, and investigators to identify operational risks before study activation.
What is the IIT Planning Meeting?
A participant is enrolled even though they failed a required eligibility lab criterion.
What is a protocol violation?
Eligibility criteria state participants must have “adequate organ function” without defining specific lab thresholds.
What is vague eligibility criteria?
A participant receives study drug before eligibility is confirmed, placing them at significant safety risk.
What is Serious Noncompliance (SNC)?
This PD process occurs before PRMC submission and uses tools like PQRT and QC checklists to identify protocol issues early.
What is PD QC review?
A coordinator accidentally uses an outdated informed consent form after the new version was IRB-approved.
What is a protocol violation?
Dose modification instructions conflict between two sections of the protocol, leading to inconsistent treatment holds between coordinators.
What is inconsistent protocol language?
A study team repeatedly fails to submit protocol deviations to the IRB despite prior corrective actions.
What is Continuing Noncompliance (CNC)?
This workflow step helps prevent enrollment deviations by refining eligibility criteria and operational details before the full protocol is drafted.
What is synopsis development and review?
A participant misses one optional quality-of-life questionnaire during Cycle 3.
What is a protocol deviation?
A protocol requires research labs before dosing but never specifies who must review and approve the labs before treatment administration.
What is unclear operational workflow responsibility?
An investigator intentionally changes protocol procedures without IRB approval, significantly impacting participant safety.
What is Serious Noncompliance (SNC)?
This part of the workflow helps identify confusing or inconsistent language before submission to FDA, PRMC, and IRB.
What is internal protocol review and tracked-change reconciliation?