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“headline”: “SOP for Dual Approvals Coordination”,
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“description”: “Comprehensive SOP for coordinating dual approvals from CONEP (National Ethics Commission) and ANVISA (National Health Surveillance Agency) in Brazil, ensuring timely clinical trial governance and compliance.”,
“keywords”: “ANVISA clinical trial SOP, dual approvals CONEP ANVISA, Brazilian regulatory SOP, SOP for CONEP coordination, ANVISA trial governance, SOP for ethics and regulatory approvals Brazil, CONEP ANVISA submission workflow, SOP for dual approval timelines, regulatory compliance SOP Brazil, SOP for sponsor obligations Brazil, ANVISA inspection readiness SOP, SOP for clinical trial governance Brazil, dual submission SOP Brazil, SOP for trial lifecycle ANVISA, SOP for CONEP site ethics Brazil, SOP for clinical trial sponsor Brazil, regulatory approval log Brazil, SOP for trial start-up Brazil, ethics compliance SOP Brazil, SOP for document submissions ANVISA, SOP for investigator responsibilities Brazil, SOP for ANVISA CTA submissions, SOP for CONEP approvals, SOP for CRO coordination Brazil, SOP for dual governance clinical trials”,
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“datePublished”: “2025-08-28”,
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Dual Approvals Coordination SOP

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.

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

Documents

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

References

• ANVISA — National Health Surveillance Agency
• CONEP — National Commission for Ethics in Research
• ICH E6(R2) Good Clinical Practice

Version: 1.0

Approval

Annexures

Annexure-1: Dual Approvals Submission Log

Annexure-2: Amendment Log

Annexure-3: Approval Tracker

Revision History

For more SOPs visit: Pharma SOP.