Trusted Resource for Clinical Trials, Protocols & Progress
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.
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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.
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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.
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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.
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