Subject Recruitment, Screening & Retention Flashcards

What action should a PI take upon discovering that an enrolled subject did not meet a key exclusion criterion at the time of enrollment?

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IRB and sponsor, who then determine—based on risk and protocol requirements—whether the subject should continue or be withdrawn.

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):

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.

Under which circumstance must a subject's eligibility typically be re-verified after initial enrollment?

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.

Why is monitoring a site's screen failure rate important for a principal investigator?

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.

How should data from a subject who was enrolled but later found to have violated a key exclusion criterion be handled?

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.

Which type of recruitment material typically requires IRB review and approval before it can be used to solicit study participants?

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.

When the PI delegates recruitment activities to sub-investigators or study coordinators, the PI's primary responsibility is to ensure that:

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.