CCRC Protocol Deviations & Amendments 3

Question 1

A protocol amendment that changes the primary study endpoint requires:

Accepted Answer

IRB review and approval before implementation at the site

Answer

Only sponsor notification without IRB review

Answer

Only a notation added to the site's study file

Answer

Immediate implementation followed by retroactive IRB review

Question 2

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

Accepted Answer

A study visit completed one day outside the allowed window with no impact on data quality

Answer

Enrollment of a participant who failed a key exclusion criterion

Answer

Failure to obtain informed consent before conducting study procedures

Answer

Administration of a prohibited concomitant medication throughout the study

Question 3

Under which circumstance may a site implement a protocol change BEFORE receiving formal IRB approval?

Accepted Answer

When the change is needed to eliminate an immediate hazard to participants

Answer

When the sponsor requests immediate implementation in writing

Answer

When the PI deems it clinically appropriate for a specific participant

Answer

When the change is purely administrative in nature and does not affect procedures

Question 4

Which of the following information must be included in a deviation report submitted to the sponsor?

Accepted Answer

Description of the deviation, date, impact on safety and data, and corrective/preventive actions taken

Answer

Financial compensation records for all site staff involved

Answer

Only the date and the affected participant's ID number

Answer

A complete list of all participants currently enrolled in the study

Question 5

Protocol deviations that affect participant safety must typically be reported to the IRB within:

Accepted Answer

The timeframe specified by the IRB's own policies, often within 5–10 business days

Answer

6 months of the occurrence

Answer

Only at the annual continuing review submission

Answer

1 year of the occurrence date

Question 6

Which section of the ICH GCP E6(R2) guideline specifically addresses clinical trial protocol content and protocol amendments?

Accepted Answer

Section 6 — Clinical Trial Protocol and Protocol Amendment(s)

Answer

Section 2 — Principles of ICH GCP

Answer

Section 8 — Essential Documents for the Conduct of a Clinical Trial

Answer

Section 3 — Institutional Review Board / Independent Ethics Committee

Question 7

After identifying a repeated pattern of the same protocol deviation at a site, the CRC and PI should FIRST:

Accepted Answer

Conduct a root cause analysis and implement a CAPA (Corrective and Preventive Action) plan

Answer

Close the site immediately pending investigation

Answer

Remove all affected participants from the study

Answer

Notify the FDA directly without involving the sponsor