SOP for EC approval letters – Clinical Research Made Simple

SOP for EC/IRB Communications (Minutes, Decisions, Correspondence)

digi — Sat, 09 Aug 2025 10:00:08 +0000

SOP for EC/IRB Communications (Minutes, Decisions, Correspondence)

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

Department	Clinical Research
SOP No.	CR/ETH/010/2025
Supersedes	NA
Page No.	1 of 22
Issue Date	26/08/2025
Effective Date	01/09/2025
Review Date	01/09/2026

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

EC/IRB Meeting Minutes Template (Annexure-1)
Decision Letter Template (Annexure-2)
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

For more SOPs visit: Pharma SOP

SOP for Initial EC/IRB Submission and Approval Tracking

digi — Thu, 07 Aug 2025 02:31:55 +0000

SOP for Initial EC/IRB Submission and Approval Tracking

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Standard Operating Procedure for Initial EC/IRB Submission and Approval Tracking in Clinical Trials

Department	Clinical Research
SOP No.	CR/ETH/006/2025
Supersedes	NA
Page No.	1 of 21
Issue Date	26/08/2025
Effective Date	01/09/2025
Review Date	01/09/2026

Purpose

The purpose of this SOP is to provide standardized instructions for preparing, submitting, and tracking initial applications to Ethics Committees (EC) or Institutional Review Boards (IRB) for clinical trials. This ensures compliance with ICH-GCP, WHO, FDA, EMA, and CDSCO requirements while safeguarding the rights, safety, and well-being of trial participants.

Scope

This SOP applies to all clinical trial staff, investigators, regulatory affairs teams, and quality assurance personnel responsible for submitting trial protocols and related documents to EC/IRBs for initial review and approval before trial initiation.

Responsibilities

Principal Investigator (PI): Prepares the submission package including protocol, informed consent forms, and investigator’s brochure.
Regulatory Affairs Manager: Coordinates submission and ensures compliance with local and international regulations.
Clinical Research Associate (CRA): Supports documentation and follows up with EC/IRB on submission status.
Quality Assurance Officer: Reviews the package for completeness and regulatory compliance.
Head of Clinical Research: Approves the final submission package prior to dispatch.

Accountability

The Regulatory Affairs Head is accountable for ensuring timely submission and approval tracking of EC/IRB applications. Any delays or errors may result in trial initiation delays or non-compliance findings during inspections.

Procedure

1. Preparation of Submission Package
Collect required documents: Clinical Trial Protocol, Investigator’s Brochure (IB), Informed Consent Form (ICF), Case Report Forms (CRFs), subject recruitment materials, and insurance certificates.
Ensure documents are in line with ICH-GCP and local regulations.
Prepare cover letter summarizing submission contents.

2. Internal Review and Approval
QA reviews submission package for accuracy and completeness.
Obtain approvals from PI and Head of Clinical Research.
Maintain version control for all documents submitted.

3. Submission to EC/IRB
Submit package electronically or in hard copy as per EC/IRB requirements.
Ensure acknowledgment receipt from EC/IRB is obtained and filed.

4. Approval Tracking
Record submission and approval dates in the EC/IRB Approval Tracker.
Follow up periodically with EC/IRB for review status.
File approval letters and conditions in the Trial Master File (TMF).

5. Communication and Implementation
Communicate approval status to sponsor and trial sites.
Implement EC/IRB requirements or conditions before trial initiation.