Patient Recruitment, Screening, and Enrollment
This domain tests the practical pipeline: how participants are found, how eligibility is proven from source documents, and at what moment a person formally becomes a study participant. Items often present a borderline candidate - a lab value one decimal outside the range, a washout period not quite complete - and ask what the coordinator may do next.
Recruitment materials and pre-screening
- All advertising and recruitment material needs IRB review before use. It must not state or imply certainty of benefit, offer "free medical care" misleadingly, or use coercive incentives.
- Reviewing existing medical records to find candidates requires HIPAA authorisation or an IRB-approved partial waiver for recruitment. A separate "consent to screen" is needed when screening activities exceed what the waiver allows.
- Recruitment realism: track number-needed-to-screen (screened ÷ randomised) to forecast whether the enrolment target is achievable.
Proving eligibility
- Every inclusion criterion must be met and every exclusion criterion absent, documented in the source with date, value and the identity of the assessor.
- Re-screening after a screen failure is permitted only if the protocol allows it; otherwise the candidate cannot re-enter for that study.
- Screening windows (for example, labs valid within 14 days of first dose) are part of eligibility, not administrative convenience.
The enrolment definition matters
Protocols define "enrolled" differently - at consent signature, at randomisation, or at first dose. Read the definition before you answer a question about enrolment numbers.
Diversity and generalisability
Regulators expect enrolment plans that reflect the epidemiology of the indication; systematic underrepresentation of older adults, minority groups or renal impairment limits labelling and is a review issue.
Worked example
A candidate has HbA1c 8.6% against an exclusion of ">8.5%." The coordinator asks the PI to "recheck next week." Reasoning: the candidate currently meets an exclusion criterion and has failed screening. A repeat test is acceptable only if the protocol permits retesting within the screening window and the sponsor agrees; otherwise no enrolment. Enrolling "pending" labs, or holding the participant in limbo past the screening window, is a deviation and an inspection finding.
Traps that cost marks
- Pre-screening from clinic records with no waiver or authorisation.
- Enrolling before the last criterion is documented, or documenting eligibility retrospectively.
- Using advertising channels the IRB did not approve; per-head "finder's fees" for referral.
- Counting consented-but-not-randomised people as enrolled when the protocol defines enrolled as randomised.