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

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.

Abbreviations

• SOP: Standard Operating Procedure
• EC: Ethics Committee
• IRB: Institutional Review Board
• PI: Principal Investigator
• CRA: Clinical Research Associate
• QA: Quality Assurance
• IB: Investigator’s Brochure
• ICF: Informed Consent Form
• CRF: Case Report Form
• TMF: Trial Master File

Documents

1. Initial EC/IRB Submission Checklist (Annexure-1)
2. EC/IRB Approval Tracker (Annexure-2)
3. EC/IRB Communication Log (Annexure-3)

References

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

Version: 1.0

Approval Section

Annexures

Annexure-1: Initial EC/IRB Submission Checklist

Annexure-2: EC/IRB Approval Tracker

Annexure-3: EC/IRB Communication Log

Revision History

For more SOPs visit: Pharma SOP