CPI Subject Recruitment, Screening & Retention 2

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?

Accepted Answer

Report the deviation to the IRB and sponsor and follow their guidance regarding subject continuation

Answer

Continue the subject's participation without notification to avoid drawing attention to the error

Answer

Immediately withdraw the subject and make no further record of their data

Answer

Transfer full responsibility for the subject to the study sponsor

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):

Accepted Answer

Enrollment/accrual log

Answer

Protocol deviation log

Answer

Adverse event summary

Answer

Delegation of authority log

Question 3

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

Accepted Answer

Whenever the protocol specifies it, such as confirming lab values before each treatment cycle

Answer

Re-verification is never required once a subject has been enrolled

Answer

Only when the IRB issues a formal request for re-verification

Answer

Only when a protocol amendment changes the inclusion/exclusion criteria

Question 4

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

Accepted Answer

It helps assess whether the recruitment source is reaching the appropriate population and whether protocol criteria are realistic

Answer

It determines the site's per-subject payment from the sponsor

Answer

It must be submitted to the FDA on a monthly basis

Answer

It replaces the need for maintaining a protocol deviation log

Question 5

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

Accepted Answer

Managed per protocol and sponsor guidance, typically retained and documented as a protocol deviation

Answer

Deleted from all databases immediately to protect the integrity of the dataset

Answer

Automatically moved to a separate exploratory analysis arm without documentation

Answer

Excluded from all analyses without any notation in the clinical study report

Question 6

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

Accepted Answer

Study advertisements or flyers posted publicly or distributed to potential subjects

Answer

Informal word-of-mouth referrals from existing subjects

Answer

Physician referrals made during routine clinical care within the same institution

Answer

Internal emails sent only to clinical staff asking for patient referrals

Question 7

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

Accepted Answer

Delegated staff are appropriately trained on eligibility criteria and ethical recruitment practices

Answer

Delegated staff recruit subjects independently without PI oversight to maximize efficiency

Answer

The IRB individually approves each staff member's participation in writing

Answer

Delegation automatically transfers regulatory liability from the PI to the sponsor