SOP for Dual Approvals Coordination

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SOP for Dual Approvals Coordination

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Published on 22/12/2025

Dual Approvals Coordination SOP

Department Clinical Research
SOP No. CS/ANVISA-APP/181/2025
Supersedes N.A.
Page No. 1 of 22
Issue Date 28/08/2025
Effective Date 05/09/2025
Review Date 05/09/2027

Purpose

This SOP establishes procedures for coordinating dual approvals required from CONEP (National Commission for Ethics in Research) and ANVISA (National Health Surveillance Agency) for clinical trials in Brazil. It ensures alignment of ethics and regulatory approvals for timely trial initiation and compliance with Brazilian law and ICH GCP.

Scope

This SOP applies to all sponsor-initiated clinical trials in Brazil requiring simultaneous or sequential approvals from CONEP and ANVISA. It covers initial Clinical Trial Application (CTA), ethics submissions, amendments, safety reporting, and ongoing lifecycle obligations. It applies to sponsors, CROs, investigators, and regulatory affairs teams.

Responsibilities

  • Sponsor: Prepares submission dossiers for both CONEP and ANVISA and ensures approvals are secured prior to trial initiation.
  • Regulatory Affairs (RA): Manages the dual submission process, ensures communication consistency, and tracks timelines.
  • Principal Investigator (PI): Provides site-specific documentation and ensures site compliance with CONEP and ANVISA approvals.
  • Clinical Project Manager (CPM): Coordinates timelines and ensures approvals are documented in TMF.
  • Quality Assurance (QA): Audits approval packages and ensures readiness for ANVISA inspections.
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Accountability

The Sponsor’s Head of Regulatory Affairs is accountable for ensuring accurate and timely submissions to CONEP and ANVISA. The PI is accountable for site-level adherence to dual approval requirements.

Procedure

1. Preparation of Submission Packages

  1. Compile CTA package for ANVISA, including protocol, Investigator’s Brochure (IB), investigational product information, and GMP certificates.
  2. Prepare ethics submission package for CONEP including protocol, ICFs, recruitment materials, and investigator CVs.

2. Submission Process

  1. Submit ethics dossier to CONEP via Plataforma Brasil.
  2. Submit CTA dossier to ANVISA through the electronic submission portal.
  3. Record submission acknowledgments in Dual Approvals Submission Log.

3. Coordination of Approvals

  1. Monitor timelines to ensure both CONEP and ANVISA approvals are received before trial initiation.
  2. Communicate with both authorities regarding queries or requests for additional information.

4. Amendments

  1. Submit substantial amendments simultaneously to CONEP and ANVISA.
  2. Document approvals in Amendment Log.

5. Safety Reporting

  1. Submit SUSARs and DSURs to both CONEP and ANVISA as per timelines.
  2. File acknowledgment receipts in TMF and ISF.

6. Documentation and Archiving

  1. Maintain submission logs, approval letters, and acknowledgments in TMF.
  2. Archive documents for at least 15 years or per Brazilian requirements.

Abbreviations

  • ANVISA: Agência Nacional de Vigilância Sanitária
  • CONEP: Comissão Nacional de Ética em Pesquisa
  • CTA: Clinical Trial Application
  • IB: Investigator’s Brochure
  • ICF: Informed Consent Form
  • PI: Principal Investigator
  • RA: Regulatory Affairs
  • QA: Quality Assurance
  • CPM: Clinical Project Manager
  • TMF: Trial Master File
  • ISF: Investigator Site File
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Documents

  1. Dual Approvals Submission Log (Annexure-1)
  2. Amendment Log (Annexure-2)
  3. Approval Tracker (Annexure-3)

References

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: Dual Approvals Submission Log

Date Authority Protocol No. Submission Type Reference No. Status
05/08/2025 ANVISA BRA-2025-01 Initial CTA ANV-001 Under Review
06/08/2025 CONEP BRA-2025-01 Initial Ethics Submission CON-101 Approved

Annexure-2: Amendment Log

Date Amendment Summary Submitted To Status
18/09/2025 Amendment 1 Updated SAE reporting process ANVISA & CONEP Pending

Annexure-3: Approval Tracker

Authority Protocol No. Approval Ref Approval Date Status
ANVISA BRA-2025-01 ANV-APP-010 22/09/2025 Approved
CONEP BRA-2025-01 CON-APP-050 20/09/2025 Approved

Revision History

Revision Date Revision No. Revision Details Reason for Revision Approved By
28/08/2025 1.0 Initial SOP for dual approvals coordination (CONEP + ANVISA). New SOP created for compliance with Brazilian regulatory requirements. Head of Clinical Research

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