Protocol Navigation
What section of a protocol gives you the quickest high-level view of when study procedures occur?
What is the Schedule of Assessments / Schedule of Activities (SoA)?
True or false: A participant who appears to meet all eligibility criteria during chart review is officially eligible for the trial.
What is false?
Complete the statement: Informed consent is a ________, not merely a signature.
What is a process?
Bonus: What ethical principle is especially relevant?
Respect for Persons.
A coordinator discovers on the morning of treatment that the order set, lab plan, and treatment schedule do not align with the current protocol amendment. What is the safest first response?
What is pause the affected study activity, verify the current approved requirements, and escalate/resolve the discrepancy before proceeding?
You find a procedure listed in the Schedule of Assessments, but a footnote adds a timing restriction. Which instruction should guide execution?
What is the complete protocol requirement, including the applicable footnote?
During prescreening, a required laboratory value cannot be found in the medical record. Should the criterion be marked “met”?
What is No — UNKNOWN / MORE INFORMATION NEEDED?
What technique asks a participant to explain study information back in their own words?
What is teach-back?
Before a team member performs a study-specific task, name one thing that should be verified.
What is appropriate qualification, training, delegation, and authorization/scope as applicable?
Who retains overall responsibility for the conduct of the clinical investigation at the site even when study tasks are delegated?
Who is the Principal Investigator / Investigator?
Assessment → Endpoint → Objective → Data → Timepoint
What is Objective → Endpoint → Assessment → Timepoint → Data?
A criterion requires confirmation of prior therapy, but the only evidence is the patient's recollection. What should the CRP do?
What is verify the criterion using an appropriate source before concluding it is met?
ICF Version 4 became effective yesterday, but the coordinator accidentally printed Version 3. The participant is ready to sign. What should happen?
What is STOP and obtain the currently applicable IRB-approved consent document before proceeding?
A lab kit expires tomorrow, but the participant's visit is scheduled next week. What should the CRP do?
What is obtain an appropriate in-date kit/supplies rather than use the expired kit?
What does ALCOA stand for?
What are Attributable, Legible, Contemporaneous, Original, and Accurate?
+ bonus points: Complete, Consistent, Enduring, Available.
A procedure appears permitted by the main protocol table, but an appendix provides additional conditions. What should the coordinator do?
What is cross-reference the applicable appendix and follow the complete protocol requirement before proceeding?
All eligibility criteria appear satisfied except one required molecular result is still pending. Treatment is scheduled tomorrow. What is the appropriate action?
What is do not confirm eligibility or proceed with protocol treatment until the required criterion is established according to the protocol and applicable process?
A Spanish-speaking participant is most comfortable communicating in Spanish. Their adult daughter offers to translate the English consent form. What should the CRP do?
What is pause and verify the IRB-approved language-access and consent pathway before proceeding?
What five questions help turn a protocol requirement into an operational plan?
What are WHO → WHAT → WHEN → WHERE → HOW?
A protocol-required assessment occurs outside the permitted window. What type of issue should the team evaluate?
What is a protocol deviation, with evaluation of impact and applicable documentation/reporting requirements?
You cannot determine from the protocol whether a participant's situation is permitted. What is the strongest CRP response?
What is STOP → RESEARCH → ESCALATE → CLARIFY → DOCUMENT?
A PI believes a participant is clinically appropriate for the trial, but the participant does not meet a protocol eligibility criterion. Can investigator judgment alone override the criterion?
What is No — not unless the protocol and applicable approved process specifically permit the situation?
An enrolled participant is returning tomorrow. A newly approved consent form contains a significant new risk. What must the team determine before the participant's next applicable study activity?
What is whether the approved reconsent plan requires the participant to receive and consent to the new information before continued participation or the next applicable activity?
The protocol requires a time-sensitive PK draw, but the clinic schedule conflicts with the required collection window. What should the coordinator do before the visit?
What is identify the conflict early and coordinate the operational plan so the protocol-required timing can be met, escalating if necessary?
A team member performs a study procedure before being appropriately delegated and trained. What should happen next?
What is preserve and document the facts, assess participant/data impact, notify/escalate through the appropriate study/institutional pathways, and determine corrective/preventive action?