CPI Subject Recruitment, Screening & Retention 2 — Questions and Answers
Question 1: What action should a PI take upon discovering that an enrolled subject did not meet a key exclusion criterion at the time of enrollment?
- Continue the subject's participation without notification to avoid drawing attention to the error
- Immediately withdraw the subject and make no further record of their data
- Report the deviation to the IRB and sponsor and follow their guidance regarding subject continuation (Correct answer)
- Transfer full responsibility for the subject to the study sponsor
Correct answer: Report the deviation to the IRB and sponsor and follow their guidance regarding subject continuation
An enrollment eligibility deviation must be reported to the IRB and sponsor, who then determine—based on risk and protocol requirements—whether the subject should continue or be withdrawn.
Question 2: A site-level document that tracks the cumulative number of subjects screened, enrolled, and who completed or withdrew from the study is called a(n):
- Protocol deviation log
- Enrollment/accrual log (Correct answer)
- Adverse event summary
- Delegation of authority log
Correct answer: Enrollment/accrual log
An enrollment or accrual log captures the flow of subjects through screening, enrollment, and study completion, providing an at-a-glance summary of site recruitment performance.
Question 3: Under which circumstance must a subject's eligibility typically be re-verified after initial enrollment?
- Re-verification is never required once a subject has been enrolled
- Only when the IRB issues a formal request for re-verification
- Whenever the protocol specifies it, such as confirming lab values before each treatment cycle (Correct answer)
- Only when a protocol amendment changes the inclusion/exclusion criteria
Correct answer: Whenever the protocol specifies it, such as confirming lab values before each treatment cycle
Many protocols require re-verification of specific eligibility parameters (e.g., organ function labs) at defined time points to confirm the subject remains appropriate for continued treatment.
Question 4: Why is monitoring a site's screen failure rate important for a principal investigator?
- It determines the site's per-subject payment from the sponsor
- It helps assess whether the recruitment source is reaching the appropriate population and whether protocol criteria are realistic (Correct answer)
- It must be submitted to the FDA on a monthly basis
- It replaces the need for maintaining a protocol deviation log
Correct answer: It helps assess whether the recruitment source is reaching the appropriate population and whether protocol criteria are realistic
A high screen failure rate signals that the recruitment source may not match the target population or that criteria are overly restrictive, enabling the PI to refine recruitment strategies.
Question 5: How should data from a subject who was enrolled but later found to have violated a key exclusion criterion be handled?
- Deleted from all databases immediately to protect the integrity of the dataset
- Managed per protocol and sponsor guidance, typically retained and documented as a protocol deviation (Correct answer)
- Automatically moved to a separate exploratory analysis arm without documentation
- Excluded from all analyses without any notation in the clinical study report
Correct answer: Managed per protocol and sponsor guidance, typically retained and documented as a protocol deviation
Data integrity requires that improperly enrolled subjects are documented as protocol deviations; the protocol and sponsor define how such data are handled in primary or sensitivity analyses.
Question 6: Which type of recruitment material typically requires IRB review and approval before it can be used to solicit study participants?
- Informal word-of-mouth referrals from existing subjects
- Physician referrals made during routine clinical care within the same institution
- Study advertisements or flyers posted publicly or distributed to potential subjects (Correct answer)
- Internal emails sent only to clinical staff asking for patient referrals
Correct answer: Study advertisements or flyers posted publicly or distributed to potential subjects
Recruitment advertisements and flyers represent the first communication with potential subjects and must be IRB-approved to ensure they are not coercive, misleading, or otherwise unethical.
Question 7: When the PI delegates recruitment activities to sub-investigators or study coordinators, the PI's primary responsibility is to ensure that:
- Delegated staff recruit subjects independently without PI oversight to maximize efficiency
- The IRB individually approves each staff member's participation in writing
- Delegation automatically transfers regulatory liability from the PI to the sponsor
- Delegated staff are appropriately trained on eligibility criteria and ethical recruitment practices (Correct answer)
Correct answer: Delegated staff are appropriately trained on eligibility criteria and ethical recruitment practices
The PI remains ultimately accountable for all site activities and must verify that delegated staff are trained on the protocol, eligibility criteria, and ICH GCP ethical recruitment standards.
CPI Subject Recruitment, Screening & Retention 2
What action should a PI take upon discovering that an enrolled subject did not meet a key exclusion criterion at the time of enrollment?