South Africa, SOP for EC community approval South Africa, SOP for engagement documentation SOP, SOP for ethics monitoring community trials, SOP for capacity building HIV TB trials, SOP for compliance inspection readiness South Africa, SOP for communication with local communities, SOP for subject protection vulnerable populations, SOP for trial governance community engagement”,
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Published on 26/12/2025

Community Engagement in HIV, TB and Vulnerable Groups SOP

Department	Clinical Research
SOP No.	CS/SAHPRA-COMM/186/2025
Supersedes	N.A.
Page No.	1 of 24
Issue Date	28/08/2025
Effective Date	05/09/2025
Review Date	05/09/2027

Purpose

This SOP defines procedures for community engagement in clinical trials involving HIV, TB, and vulnerable populations in South Africa. It ensures participants are informed, culturally respected, and ethically protected, in line with SAHPRA, Ethics Committee (EC), and Good Clinical Practice (GCP) requirements.

Scope

This SOP applies to all sponsor-led and investigator-initiated trials in South Africa that involve vulnerable populations, including people living with HIV, TB patients, and socioeconomically disadvantaged communities. It covers engagement planning, outreach, ethics review, community advisory board (CAB) interactions, and ongoing monitoring.

Responsibilities

• Sponsor: Ensures community engagement strategies are developed and approved before trial initiation.
• Principal Investigator (PI): Implements site-level engagement and maintains communication with local communities.
• Community Advisory Board (CAB): Provides input on cultural sensitivity and trial acceptability.
• Clinical Research Coordinator (CRC): Facilitates community education sessions and maintains engagement logs.
• Regulatory Affairs (RA): Submits engagement plans to EC for approval.
• Quality Assurance (QA): Audits community engagement activities for compliance.

Accountability

The Sponsor’s Head of Clinical Operations is accountable for ensuring community engagement strategies are aligned with regulatory expectations. The PI is accountable for ensuring ongoing communication with trial participants and vulnerable groups.

Procedure

1. Development of Community Engagement Plan

1. Draft a Community Engagement Plan outlining objectives, stakeholders, and methods of engagement.
2. Submit the plan to EC for approval before trial initiation.
3. Maintain plan in TMF and update as required.

2. Formation of Community Advisory Board (CAB)

1. Identify and recruit members from local communities, advocacy groups, and healthcare representatives.
2. Define CAB terms of reference and meeting schedules.

3. Community Outreach Activities

1. Conduct pre-trial sensitization workshops in local languages.
2. Provide culturally appropriate educational materials.
3. Document community questions and feedback in Outreach Log.

4. Ongoing Engagement During Trial

1. Hold quarterly CAB meetings to discuss trial progress and concerns.
2. Maintain transparent communication with participants regarding safety updates and trial outcomes.

5. Ethics Oversight

1. Submit records of community engagement activities to ECs periodically.
2. Address EC feedback and update engagement strategies as required.

6. Documentation and Archiving

1. Maintain Engagement Logs, CAB meeting minutes, and Outreach Logs in TMF and ISF.
2. Archive engagement records for at least 15 years or per SAHPRA requirements.

Abbreviations

• SAHPRA: South African Health Products Regulatory Authority
• EC: Ethics Committee
• CAB: Community Advisory Board
• PI: Principal Investigator
• CRC: Clinical Research Coordinator
• RA: Regulatory Affairs
• QA: Quality Assurance
• TMF: Trial Master File
• ISF: Investigator Site File

Documents

1. Community Engagement Plan (Annexure-1)
2. Outreach Log (Annexure-2)
3. CAB Meeting Minutes (Annexure-3)

References

• SAHPRA — Clinical Trials
• ICH E6(R2) Good Clinical Practice
• Office for Human Research Protections (OHRP)

Version: 1.0

Approval

Prepared By	Checked By	Approved By
Name: Rajesh Kumar Date: 20/08/2025 Signature: __________	Name: Sunita Reddy Date: 22/08/2025 Signature: __________	Name: Dr. Meera Iyer Date: 28/08/2025 Signature: __________

Annexures

Annexure-1: Community Engagement Plan

Objective	Stakeholders	Method	Frequency
Increase awareness	Local NGOs	Workshops	Quarterly

Annexure-2: Outreach Log

Date	Location	Activity	Participants	Feedback
10/08/2025	Johannesburg	HIV Awareness Workshop	45	Positive, requested more visual aids

Annexure-3: CAB Meeting Minutes

Date	Topic	Decisions	Action Owner
15/08/2025	Trial Recruitment	Agreed to use radio announcements	Neha Sharma

Revision History

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
28/08/2025	1.0	Initial SOP for community engagement in HIV, TB, and vulnerable groups.	New SOP created for SAHPRA compliance and ethical governance.	Head of Clinical Research

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