Protocol Deviations and Violations Flashcards
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Read the first 7 Protocol Deviations and Violations flashcards as text
Which of the following is an example of a PROSPECTIVE protocol deviation?
Answer: Obtaining IRB approval to temporarily waive a procedure before it is missed
A prospective deviation occurs when the site identifies a potential departure in advance and obtains appropriate approvals or waivers before the scheduled procedure.
A subject on a clinical trial inadvertently received a double dose of the investigational product. What is the MOST appropriate immediate action?
Answer: Assess subject safety, report as an adverse event if applicable, and document as a protocol deviation
A dosing error must trigger immediate safety assessment, adverse event reporting if warranted, and documentation as a protocol deviation, with notification to the PI, sponsor, and IRB per their requirements.
Under 21 CFR Part 312, which of the following protocol deviations requires prompt reporting to the FDA?
Answer: Changes to eliminate immediate hazards to subjects, reported as soon as possible
21 CFR 312.62 and ICH E6 both require that protocol changes implemented to eliminate immediate hazards be reported to the FDA and IRB as soon as possible after the changes are made.
Which element is MOST important to include in a protocol deviation report submitted to the IRB?
Answer: A description of the deviation, the impact on subject safety/data integrity, and corrective actions taken
IRB deviation reports must describe what occurred, assess the impact on subject safety and data integrity, and outline corrective/preventive actions to be taken.
A CAPA (Corrective and Preventive Action) plan is developed in response to a protocol deviation. What is the PRIMARY purpose of the 'preventive' component?
Answer: To identify and address root causes to prevent recurrence of similar deviations
The preventive component of a CAPA focuses on identifying the root cause of the deviation and implementing systemic changes to prevent similar events from recurring.
During an FDA inspection, an investigator is found to have multiple unreported protocol deviations. What is the MOST likely consequence?
Answer: An FDA Form 483 observation, a Warning Letter, or potential disqualification of the investigator
Failure to report protocol deviations can result in FDA 483 inspectional observations, Warning Letters, or investigator disqualification proceedings under 21 CFR Part 312.
Which of the following BEST describes a 'waiver' in the context of protocol deviations?
Answer: Prior written approval from the IRB or sponsor to deviate from a specific protocol requirement
A protocol waiver is prospective written authorization from the sponsor and/or IRB to deviate from a specific protocol requirement under defined circumstances, obtained before the deviation occurs.