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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.

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SUSAR and SAE Reporting via National Systems SOP

Purpose

The purpose of this SOP is to establish standardized processes for reporting Suspected Unexpected Serious Adverse Reactions (SUSARs) and Serious Adverse Events (SAEs) through Brazil’s national pharmacovigilance systems (e.g., Notivisa). It ensures timely compliance with ANVISA’s regulatory requirements, maintaining patient safety and data integrity.

Scope

This SOP applies to all clinical trials sponsored or managed by the organization in Brazil under ANVISA oversight. It covers expedited SUSAR reporting, SAE submissions, data entry into Notivisa, narrative preparation, Development Safety Update Report (DSUR) submissions, and responsibilities of sponsors, investigators, and CROs.

Responsibilities

• Principal Investigator (PI): Identifies and reports SAEs to the sponsor within 24 hours, maintains source documentation, and ensures SAE forms are complete.
• Clinical Research Coordinator (CRC): Supports SAE reporting and ensures site documentation is filed in the Investigator Site File (ISF).
• Pharmacovigilance (PV) Team: Performs medical assessment, prepares SUSAR narratives, and submits cases into Notivisa.
• Regulatory Affairs (RA): Confirms case acknowledgments from ANVISA and ensures DSURs are submitted on time.
• Quality Assurance (QA): Audits SAE and SUSAR processes, ensuring compliance with Brazilian law and inspection readiness.

Accountability

The Sponsor’s Qualified Person for Pharmacovigilance (QPPV) in Brazil is accountable for ensuring timely and accurate SUSAR and SAE submissions to ANVISA. The Head of Clinical Research is accountable for overall compliance oversight.

Procedure

1. Identification and Initial Reporting

1. Investigators document SAEs in the SAE Report Form immediately upon awareness.
2. Forward SAE reports to the sponsor within 24 hours for evaluation.
3. Ensure medical records and source data are included for causality and expectedness assessment.

2. SUSAR Reporting Timelines

1. Fatal or life-threatening SUSARs: submit to Notivisa within 7 calendar days, with follow-up within 8 days.
2. Other SUSARs: submit within 15 calendar days.

3. Data Entry into Notivisa

1. PV team enters SUSAR and SAE cases into Notivisa using secure login credentials.
2. Ensure all mandatory fields are completed, including narrative, laboratory data, and outcome.
3. Generate acknowledgment receipt and file in Trial Master File (TMF).

4. DSUR Submissions

1. Prepare annual DSUR with cumulative safety data.
2. Submit DSUR to ANVISA within 60 days of data lock point.
3. Maintain DSUR Tracker in TMF.

5. Privacy and Data Protection

1. Ensure SAE/SUSAR reports exclude direct subject identifiers before submission.
2. Use anonymized trial subject IDs for regulatory submissions.

6. Archiving

1. Maintain SAE and SUSAR logs, acknowledgment receipts, and DSURs in TMF and ISF.
2. Archive documents for a minimum of 15 years or as per ANVISA requirements.

Abbreviations

• ANVISA: Agência Nacional de Vigilância Sanitária
• CONEP: Comissão Nacional de Ética em Pesquisa
• SAE: Serious Adverse Event
• SUSAR: Suspected Unexpected Serious Adverse Reaction
• DSUR: Development Safety Update Report
• PV: Pharmacovigilance
• QPPV: Qualified Person for Pharmacovigilance
• PI: Principal Investigator
• CRC: Clinical Research Coordinator
• RA: Regulatory Affairs
• QA: Quality Assurance
• TMF: Trial Master File
• ISF: Investigator Site File

Documents

1. SAE Report Form (Annexure-1)
2. SUSAR Submission Log (Annexure-2)
3. DSUR Tracker (Annexure-3)

References

• ANVISA — Clinical Trials and Pharmacovigilance
• ANVISA Notivisa System
• ICH E6(R2) Good Clinical Practice
• ICH E2A: Clinical Safety Data Management
• ICH E2F: Development Safety Update Report

Version: 1.0

Approval

Annexures

Annexure-1: SAE Report Form

Annexure-2: SUSAR Submission Log

Annexure-3: DSUR Tracker

Revision History

For more SOPs visit: Pharma SOP.

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Portuguese Consent and Cultural/Ethical Considerations SOP

Purpose

The purpose of this SOP is to define standardized procedures for developing, translating, and administering Portuguese language informed consent forms (ICFs) and ensuring that cultural and ethical considerations are addressed in clinical trials conducted in Brazil. It aligns with ANVISA, CONEP, and ICH GCP requirements, ensuring participants are provided with accurate and understandable information.

Scope

This SOP applies to all clinical trials conducted in Brazil where participants require informed consent in Portuguese. It covers translation, back-translation, cultural adaptation, ethics submissions, site responsibilities, subject re-consent, and record-keeping. It is applicable to sponsors, CROs, investigators, and translation vendors involved in Brazilian clinical trials.

Responsibilities

• Sponsor: Ensures Portuguese ICFs are available, approved by CONEP, and implemented before trial initiation.
• Principal Investigator (PI): Conducts the consent process, ensures participant comprehension, and maintains signed ICFs at the site.
• Clinical Research Coordinator (CRC): Assists PI in the consent process, maintains records, and ensures participants are provided with subject-facing documents in Portuguese.
• Regulatory Affairs (RA): Submits Portuguese ICFs and supporting documentation to ANVISA and CONEP.
• Quality Assurance (QA): Verifies accuracy of translations and ensures inspection readiness.
• Translation Vendor: Provides certified translations and back-translations for ICFs and subject materials.

Accountability

The Sponsor is accountable for ensuring that consent documents are available in Portuguese and ethically sound. The PI is accountable for ensuring participant comprehension and that signed ICFs are properly documented.

Procedure

1. Translation of Informed Consent Documents

1. Engage certified medical translators for Portuguese translation of ICFs and subject materials.
2. Perform back-translation into English to confirm accuracy and consistency with original documents.
3. File Certificate of Translation Accuracy in TMF.

2. Cultural and Ethical Adaptation

1. Ensure consent documents use culturally sensitive language and avoid medical jargon.
2. Adapt terminology to align with Brazilian cultural norms and literacy levels.
3. Engage Ethics Committees (CONEP) to review cultural appropriateness of translated ICFs.

3. Informed Consent Process

1. Provide subjects with Portuguese ICFs prior to trial enrollment.
2. Allow sufficient time for subjects to read, discuss, and ask questions.
3. Ensure comprehension by asking subjects to explain trial risks and procedures in their own words.

4. Ethics and Regulatory Submissions

1. Submit Portuguese ICFs to CONEP and ANVISA along with the protocol package.
2. File ethics approval letters and acknowledgment receipts in TMF and ISF.

5. Re-Consent

1. Implement re-consent procedures in Portuguese when protocol amendments significantly impact subject rights, safety, or trial procedures.

6. Archiving

1. Maintain signed ICFs, translation logs, and approval documents in TMF and ISF.
2. Archive consent-related records for 15 years or as per Brazilian requirements.

Abbreviations

• ANVISA: Agência Nacional de Vigilância Sanitária
• CONEP: Comissão Nacional de Ética em Pesquisa
• ICF: Informed Consent Form
• PI: Principal Investigator
• CRC: Clinical Research Coordinator
• RA: Regulatory Affairs
• QA: Quality Assurance
• TMF: Trial Master File
• ISF: Investigator Site File

Documents

1. Translation Requirement Log (Annexure-1)
2. Certificate of Translation Accuracy (Annexure-2)
3. Consent Process Documentation Log (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: Translation Requirement Log

Annexure-2: Certificate of Translation Accuracy

Annexure-3: Consent Process Documentation Log

Revision History

For more SOPs visit: Pharma SOP.

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Import Licenses for Investigational Products and Biological Samples SOP

Purpose

The purpose of this SOP is to define the process for obtaining, maintaining, and managing import licenses for investigational products (IP) and biological samples for use in clinical trials conducted in Brazil. This ensures compliance with ANVISA regulations and Brazilian customs laws, while safeguarding supply chain integrity and trial continuity.

Scope

This SOP applies to all sponsor-initiated clinical trials in Brazil that require the importation of investigational medicinal products (IMPs), comparators, placebos, and biological samples for analysis. It covers license applications, renewals, customs clearance, CRO/vendor responsibilities, and documentation archiving. It applies to sponsors, investigators, CROs, and regulatory affairs teams.

Responsibilities

• Sponsor: Ensures valid import licenses are obtained before shipment of IPs or samples.
• Regulatory Affairs (RA): Prepares and submits license applications to ANVISA and coordinates renewals.
• Logistics Manager: Ensures shipments are aligned with import permits and maintains supply chain records.
• Principal Investigator (PI): Confirms receipt of imported materials at site and ensures storage per protocol.
• Quality Assurance (QA): Audits import license documentation for inspection readiness.
• CRO: Supports application and manages interactions with customs when delegated.

Accountability

The Sponsor’s Head of Regulatory Affairs is accountable for ensuring compliance with import license requirements. The PI is accountable for proper handling and documentation of imported trial materials at the site.

Procedure

1. Pre-Import Assessment

1. Determine whether investigational products or samples require import licenses under ANVISA rules.
2. Document requirements in Import Assessment Form (Annexure-1).

2. License Application

1. Prepare application dossier including protocol, IP details, MSDS, GMP certificate, and import justification.
2. Submit dossier electronically to ANVISA.
3. Record application details in Import License Submission Log.

3. Customs Clearance and Shipment

1. Ensure shipments align with approved license and contain correct labeling.
2. Maintain Import Shipment Tracker with details of customs clearance dates, reference numbers, and responsible parties.

4. Renewal of Licenses

1. Monitor expiry dates of licenses and initiate renewal process 60 days before expiration.
2. Submit updated protocol and supply chain details if required.

5. Documentation and Archiving

1. File import permits, customs clearance receipts, and correspondence in TMF.
2. Archive records for 15 years or per ANVISA requirements.

Abbreviations

• ANVISA: Agência Nacional de Vigilância Sanitária
• IP: Investigational Product
• IMP: Investigational Medicinal Product
• MSDS: Material Safety Data Sheet
• PI: Principal Investigator
• RA: Regulatory Affairs
• QA: Quality Assurance
• TMF: Trial Master File
• CRO: Contract Research Organization

Documents

1. Import Assessment Form (Annexure-1)
2. Import License Submission Log (Annexure-2)
3. Import Shipment Tracker (Annexure-3)

References

• ANVISA — Clinical Trial Imports
• ICH E6(R2) Good Clinical Practice
• ICH Quality Guidelines

Version: 1.0

Approval

Annexures

Annexure-1: Import Assessment Form

Annexure-2: Import License Submission Log

Annexure-3: Import Shipment Tracker

Revision History

For more SOPs visit: Pharma SOP.