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Standard Operating Procedure for EC/IRB Communications (Minutes, Decisions, Correspondence)

Purpose

The purpose of this SOP is to establish standardized procedures for documenting and managing all communications with Ethics Committees (EC) and Institutional Review 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

Annexures

Annexure-1: EC/IRB Meeting Minutes Template

Annexure-2: Decision Letter Template

Annexure-3: Communication Log

Revision History

For more SOPs visit: Pharma SOP

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Standard Operating Procedure for EC/IRB Continuing Review and Renewals

Purpose

The purpose of this SOP is to describe the process for conducting Ethics Committee (EC) and Institutional Review Board (IRB) continuing reviews and renewals of clinical trials. This ensures ongoing ethical oversight, participant protection, and compliance with ICH-GCP, WHO, FDA, EMA, and CDSCO regulatory requirements.

Scope

This SOP applies to all clinical research staff, investigators, regulatory affairs personnel, and quality assurance officers involved in the preparation, submission, and follow-up of EC/IRB continuing review and renewal applications for clinical trials.

Responsibilities

• Principal Investigator (PI): Prepares progress reports and renewal documents for submission to EC/IRB.
• Regulatory Affairs Manager: Coordinates submissions and ensures compliance with regional requirements.
• Clinical Research Associate (CRA): Collects site-level data and ensures accuracy of reports.
• Quality Assurance Officer: Reviews documents for completeness and compliance with applicable guidelines.
• Head of Clinical Research: Approves submissions before dispatch to EC/IRB.

Accountability

The Regulatory Affairs Head is accountable for ensuring that continuing review and renewal applications are submitted on time, complete, and compliant. Failure to maintain approvals may result in trial suspension or regulatory non-compliance.

Procedure

1. Identification of Renewal Requirement
Determine the renewal due date based on EC/IRB initial approval letter.
Notify PI and study team at least 60 days before renewal deadline.

2. Preparation of Renewal Package
Include protocol progress report, enrollment status, safety summary (AE/SAE reports), deviations, amendments since last approval, and updated Investigator’s Brochure if applicable.
Ensure all documents are updated and signed by responsible personnel.

3. Internal Review
QA reviews renewal package for completeness.
Head of Clinical Research reviews and approves the package.

4. Submission to EC/IRB
Submit renewal package in electronic or paper form as per EC/IRB requirements.
File proof of submission in Regulatory Communication Log.

5. Approval Tracking
Maintain EC/IRB Renewal Tracker with submission and approval dates.
Follow up until approval is received.

6. Post-Approval Implementation
Communicate approval to trial sites and sponsor.
Implement EC/IRB conditions, if any, prior to continuing the trial.

Abbreviations

• SOP: Standard Operating Procedure
• EC: Ethics Committee
• IRB: Institutional Review Board
• PI: Principal Investigator
• CRA: Clinical Research Associate
• QA: Quality Assurance
• AE: Adverse Event
• SAE: Serious Adverse Event
• TMF: Trial Master File

Documents

1. EC/IRB Renewal Checklist (Annexure-1)
2. EC/IRB Renewal Tracker (Annexure-2)
3. Regulatory Communication Log (Annexure-3)

References

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

Version: 1.0

Approval Section

Annexures

Annexure-1: EC/IRB Renewal Checklist

Annexure-2: EC/IRB Renewal Tracker

Annexure-3: Regulatory Communication Log

Revision History

For more SOPs visit: Pharma SOP