Protocol Development & Review Flashcards
7 cards from real CTA practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Protocol Development & Review flashcards as text
When developing a protocol for a Phase I first-in-human study, which element is MOST critical to include to protect participant safety?
Answer: Dose escalation rules and safety review criteria
Dose escalation rules and safety review criteria are critical in Phase I protocols to ensure dose increases only occur when safety thresholds are met.
A protocol specifies that subjects must have a baseline HbA1c between 7.5% and 10%. A subject with HbA1c of 7.3% is enrolled. This is an example of:
Answer: An eligibility protocol deviation that must be documented and reported
Enrolling a subject who does not meet the defined eligibility criteria constitutes an eligibility protocol deviation requiring documentation and reporting.
Which of the following best describes a 'protocol template' in the context of clinical trial operations?
Answer: A standardized framework containing required sections that can be customized for specific studies
A protocol template is a standardized framework with required sections that sponsors use as a starting point, customizing it for each specific study.
What is 'protocol feasibility' assessment and when is it conducted?
Answer: A site and sponsor evaluation of whether the protocol can be implemented successfully, conducted before study initiation
Protocol feasibility assessment evaluates whether sites can realistically enroll eligible subjects and execute protocol procedures, and is conducted before study start.
In a protocol's schedule of events (SoE), what information is typically presented?
Answer: A matrix showing all study visits, timepoints, and assessments to be performed at each visit
The Schedule of Events is a matrix that maps all study visits and timepoints against the assessments and procedures required at each visit.
Who is responsible for reviewing and approving a clinical trial protocol before the study begins at a specific site?
Answer: The IRB/IEC and, where applicable, the regulatory authority
Both the IRB/IEC and applicable regulatory authorities must review and approve the protocol before a study can begin at any site.
What is the key difference between a 'protocol violation' and a 'protocol deviation'?
Answer: Protocol violations are serious departures that may affect subject safety or data integrity; deviations are minor departures
Protocol violations are serious departures from the protocol that may affect subject rights, safety, or data integrity, while deviations are minor unintended departures.