Trusted Resource for Clinical Trials, Protocols & Progress
The purpose of this SOP is to establish requirements for the localization of clinical trial data in China and define governance measures for cross-border transfer of trial data. It ensures compliance with Chinese laws, NMPA regulations, and data protection standards to safeguard participant information and trial integrity.
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The purpose of this SOP is to outline clear procedures for the safe handling and management of spillage or incidents involving investigational products (IP) and biological materials in clinical trials. It ensures protection of staff, subjects, and the environment while maintaining proper documentation and regulatory compliance.
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This SOP defines the process for preparing, translating, and quality-assuring Chinese language informed consent forms (ICFs) and other essential trial documents. It ensures participants fully understand trial information in their native language and that sponsors comply with NMPA and ICH GCP requirements for subject comprehension and regulatory submissions.
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The purpose of this SOP is to outline the procedures for labeling investigational products (IP) intended for clinical trial use. Proper labeling ensures subject safety, product traceability, and compliance with international regulatory standards, while safeguarding blinding requirements where applicable.
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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 define standardized procedures for the identification, classification, and documentation of serious adverse events (SAEs) during clinical trials. This ensures subject safety, accurate reporting, and compliance with applicable regulatory frameworks.
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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 establish standardized procedures for reporting serious adverse events (SAEs) to the sponsor in clinical trials. This ensures subject safety, regulatory compliance, and timely communication for expedited safety reporting obligations.
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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 establish procedures for reporting serious adverse events (SAEs) to Ethics Committees (EC) or Institutional Review Boards (IRB) to protect participant safety and ensure compliance with international regulations and Good Clinical Practice (GCP).
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