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Standard Operating Procedure for Recruitment Materials Development and EC/IRB Approval

Purpose

The purpose of this SOP is to establish standardized procedures for the development, review, and approval of recruitment materials used in clinical trials. It ensures that all recruitment communications are ethically sound, scientifically accurate, and approved by Ethics Committees (EC) or Institutional Review Boards (IRB) before use.

Scope

This SOP applies to all investigators, study coordinators, sponsors, and CRO staff involved in the creation and use of recruitment materials for clinical trials. It covers advertisements, brochures, posters, online content, social media posts, radio/TV ads, and other recruitment tools.

Responsibilities

• Principal Investigator (PI): Reviews recruitment materials for scientific accuracy and compliance with protocol.
• Study Coordinator: Prepares and submits recruitment materials for EC/IRB review.
• Sponsor/CRO: Ensures materials are consistent across sites and compliant with regulatory guidelines.
• EC/IRB: Reviews and approves materials before they are disseminated to potential participants.
• Quality Assurance Officer: Verifies documentation of approvals during monitoring and audits.

Accountability

The PI is accountable for ensuring that no recruitment material is used without prior EC/IRB approval. Sponsors are accountable for oversight and compliance across all trial sites.

Procedure

1. Development of Recruitment Materials
Draft materials in clear, non-technical language.
Include study purpose, eligibility criteria, study site contact details.
Avoid coercive or misleading language.

2. Internal Review
PI and sponsor review drafts for accuracy and compliance with protocol.
Ensure messaging aligns with regulatory and ethical guidelines.

3. Submission to EC/IRB
Submit all recruitment materials to EC/IRB for review and approval.
Maintain documented evidence of submission and approval in Investigator Site File (ISF) and Trial Master File (TMF).

4. Approval and Version Control
Do not use materials until formal approval is received.
Track versions with approval stamps and dates.

5. Dissemination
Distribute only approved versions of recruitment materials.
Monitor use to prevent unauthorized changes or adaptations.

6. Archiving
Archive approved recruitment materials and approvals for at least 5 years post-trial or as per national regulations.

Abbreviations

• SOP: Standard Operating Procedure
• PI: Principal Investigator
• CRO: Clinical Research Organization
• EC: Ethics Committee
• IRB: Institutional Review Board
• ISF: Investigator Site File
• TMF: Trial Master File
• QA: Quality Assurance

Documents

1. Recruitment Material Approval Log (Annexure-1)
2. Recruitment Material Version Control Record (Annexure-2)
3. Recruitment Material Archive Log (Annexure-3)

References

• ICH E6(R2) – Good Clinical Practice
• US FDA Guidance on Recruitment Materials
• EMA Clinical Trial Regulation
• CDSCO Clinical Trial Rules, 2019
• WHO – Guidelines on Ethical Recruitment in Clinical Research

Version: 1.0

Approval Section

Annexures

Annexure-1: Recruitment Material Approval Log

Annexure-2: Recruitment Material Version Control Record

Annexure-3: Recruitment Material Archive Log

Revision History

For more SOPs visit: Pharma SOP