Boards (IRB), including meeting minutes, decisions, approval letters, and correspondence. This ensures transparency, accountability, and compliance with ICH GCP, WHO, FDA, EMA, and CDSCO requirements.

Scope

This SOP applies to all EC/IRB secretariat staff, investigators, sponsors, and regulatory personnel involved in preparing, distributing, and archiving EC/IRB communications for clinical trials. It covers routine communications, formal decisions, minutes of meetings, and correspondence with sponsors or investigators.

Responsibilities

• EC/IRB Chairperson: Ensures minutes accurately reflect deliberations and decisions.
• EC/IRB Secretariat: Prepares minutes, distributes decisions, and maintains correspondence logs.
• Investigators: Respond promptly to EC/IRB queries and implement required actions.
• Quality Assurance Officer: Reviews communication records for completeness and compliance.
• Head of Clinical Research: Oversees adherence to SOP and approves major communications if required.

Accountability

The EC/IRB Secretariat is accountable for ensuring accurate, timely, and secure documentation of all communications. Incomplete or inaccurate records may lead to regulatory non-compliance or invalidation of EC/IRB decisions.

Procedure

1. Preparation of Meeting Minutes
Secretariat drafts meeting minutes within 7 working days of EC/IRB meeting.
Minutes must include quorum details, list of attendees, protocol numbers reviewed, summary of discussions, and decisions taken.
Chairperson reviews and signs final version before distribution.

2. Recording Decisions
All EC/IRB decisions (approval, conditional approval, deferral, or disapproval) must be documented.
Decision letters must be issued to investigators and sponsors within 10 working days.
Copies must be filed in the EC/IRB Communication Log and Trial Master File (TMF).

3. Handling Correspondence
Secretariat maintains a log of all incoming and outgoing communications (letters, emails, faxes).
Each correspondence must include date, sender/receiver, subject, and reference number.
Critical correspondence must be acknowledged in writing.

4. Distribution of Communications
Copies of decisions, approvals, and minutes must be shared with investigators, sponsors, and regulatory authorities (if applicable).
Distribution must be documented in Communication Tracker.

5. Documentation and Archiving
All communications must be archived securely with restricted access.
Records must be retained for a minimum of 5 years after trial completion or longer if required by local regulations.

Abbreviations

• SOP: Standard Operating Procedure
• EC: Ethics Committee
• IRB: Institutional Review Board
• TMF: Trial Master File
• QA: Quality Assurance

Documents

1. EC/IRB Meeting Minutes Template (Annexure-1)
2. Decision Letter Template (Annexure-2)
3. Communication Log (Annexure-3)

References

• ICH E6(R2) – Good Clinical Practice
• US FDA 21 CFR Part 56 – IRB Regulations
• EMA Clinical Trial Regulation (EU No. 536/2014)
• WHO Guidelines for Ethics Committees
• CDSCO Clinical Trial Rules, 2019

Version: 1.0

Approval Section

Prepared By	Rajesh Kumar, EC/IRB Secretariat Officer
Checked By	Sunita Reddy, QA Officer
Approved By	Dr. Anil Sharma, EC/IRB Chairperson

Annexures

Annexure-1: EC/IRB Meeting Minutes Template

Date	Protocol No.	Discussion Summary	Decision	Remarks
10/09/2025	CTP-2025-06	Protocol reviewed with quorum	Approved	Condition: submit updated ICF

Annexure-2: Decision Letter Template

Date	Protocol No.	Decision	Communicated To	Signed By
15/09/2025	CTP-2025-06	Approval Granted	Principal Investigator	EC Chairperson

Annexure-3: Communication Log

Date	Sender/Receiver	Subject	Reference No.	Remarks
12/09/2025	EC Secretariat to Sponsor	Decision letter – Protocol CTP-2025-06	EC-2025-045	Sent via email

Revision History

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
26/08/2025	00	Initial version	New SOP creation	Head, Clinical Research

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