SOCRA Protocol Deviations and Violations 2

Question 1

Which of the following is an example of a PROSPECTIVE protocol deviation?

Accepted Answer

Obtaining IRB approval to temporarily waive a procedure before it is missed

Answer

Discovering after the fact that a subject's baseline labs were not collected

Answer

Realizing an ineligible subject was enrolled 3 weeks after randomization

Answer

Documenting a missed visit in the source documents after the window has passed

Question 2

A subject on a clinical trial inadvertently received a double dose of the investigational product. What is the MOST appropriate immediate action?

Accepted Answer

Assess subject safety, report as an adverse event if applicable, and document as a protocol deviation

Answer

Document only in the source records and continue the study without notification

Answer

Withdraw the subject immediately and close the case without an IRB report

Answer

Administer the corrective dose and update the protocol amendment

Question 3

Under 21 CFR Part 312, which of the following protocol deviations requires prompt reporting to the FDA?

Accepted Answer

Changes to eliminate immediate hazards to subjects, reported as soon as possible

Answer

Any deviation from the protocol, regardless of severity

Answer

Deviations that are not covered by the existing IND application

Answer

Minor administrative deviations that do not affect subject safety

Question 4

Which element is MOST important to include in a protocol deviation report submitted to the IRB?

Accepted Answer

A description of the deviation, the impact on subject safety/data integrity, and corrective actions taken

Answer

The investigator's personal opinion about whether the deviation was avoidable

Answer

The financial cost of the deviation to the sponsor

Answer

A request for additional funding to prevent future deviations

Question 5

A CAPA (Corrective and Preventive Action) plan is developed in response to a protocol deviation. What is the PRIMARY purpose of the 'preventive' component?

Accepted Answer

To identify and address root causes to prevent recurrence of similar deviations

Answer

To discipline the staff member who caused the deviation

Answer

To submit a protocol amendment to the FDA

Answer

To remove the affected subjects from the study analysis

Question 6

During an FDA inspection, an investigator is found to have multiple unreported protocol deviations. What is the MOST likely consequence?

Accepted Answer

An FDA Form 483 observation, a Warning Letter, or potential disqualification of the investigator

Answer

A routine warning letter with no further action required

Answer

Automatic approval of a protocol amendment

Answer

Immediate suspension of the IND by the sponsor

Question 7

Which of the following BEST describes a 'waiver' in the context of protocol deviations?

Accepted Answer

Prior written approval from the IRB or sponsor to deviate from a specific protocol requirement

Answer

A post-hoc justification for a deviation already committed

Answer

Sponsor permission granted after the fact to excuse a missed procedure

Answer

An FDA exemption from IND requirements for a specific site