1. Purpose

To describe ethical, compliant recruitment and the sequence of pre-screening, screening and enrolment activities, so that eligibility is established and documented before a subject receives investigational product.

2. Scope

Applies to all recruitment channels including clinic referral, chart review, registries, community outreach, print and digital advertising, and all screening and enrolment activities.

3. Responsibilities

• Patient Recruitment Manager: Develops recruitment plans and ensures all materials are IRB-approved before use.
• Pre-Screening Associate: Conducts scripted pre-screening, records outcomes, and protects the privacy of individuals who are not enrolled.
• Clinical Research Coordinators: Perform screening assessments, maintain the screening log, and document eligibility.
• Principal Investigator or delegated Sub-Investigator: Confirms and signs eligibility before enrolment.

4. Definitions

Pre-screening

Limited assessment of potential eligibility, typically by scripted telephone or chart review, before written informed consent.

Review preparatory to research

A permitted use of protected health information to prepare a research protocol or assess feasibility, without removing PHI from the covered entity.

Screen failure

A consented subject who does not meet eligibility criteria and is therefore not enrolled.

Enrolment

The point at which a consented, eligible subject is registered to the study and begins protocol-directed interventions.

5. Procedure

1. Obtain IRB approval for every recruitment material and script, including social media posts, radio copy, flyers and website text, before any public use.
2. Use only IRB-approved language; never state or imply that the investigational product is safe, effective or superior, and never present compensation as a benefit.
3. Identify potential subjects from the medical record only under a review preparatory to research, an IRB-approved waiver of authorisation, or an existing authorisation, as described in HIP-001.
4. Conduct pre-screening using the approved script, collect only the minimum necessary information, and document the outcome in the pre-screening log.
5. Store pre-screening records containing protected health information in a locked cabinet or access-controlled electronic folder, separately from the study database.
6. Obtain written informed consent per SUB-001 before performing any protocol-specified screening procedure, including laboratory tests or imaging.
7. Assign a screening number, record the subject on the screening and enrolment log, and record the date of consent.
8. Perform screening assessments within the protocol-defined screening window and document every inclusion and exclusion criterion with objective source data.
9. Obtain and document Principal Investigator or delegated Sub-Investigator confirmation of eligibility, with signature and date, before enrolment.
10. Submit any eligibility waiver request to the sponsor in writing and obtain written approval and IRB notification where required before enrolling the subject; never enrol on a verbal waiver alone.
11. Register the subject with the sponsor's randomisation or enrolment system, record the subject number, and update the enrolment log the same business day.
12. Document screen failures with the specific reason, retain the records, and report screening and enrolment metrics to the study team weekly.
13. Reconcile the screening log against the sponsor system and the investigational product accountability records monthly.

6. References

• 21 CFR Part 50 — Protection of Human Subjects
• 21 CFR Part 56 — Institutional Review Boards
• 45 CFR 164.512(i) — Research uses and disclosures
• SUB-001 Informed Consent Process & Documentation
• HIP-001 HIPAA Privacy Rule in Research

7. Revision History

• v2.0 · Apr 24, 2023 — Added digital advertising review requirements.
• v2.2 · Sep 15, 2025 — Clarified storage of pre-screening records containing PHI.