Trusted Resource for Clinical Trials, Protocols & Progress
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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The purpose of this SOP is to describe the procedures for reporting serious adverse events (SAEs) to regulatory authorities in compliance with global requirements. It ensures timely reporting, accurate documentation, and subject safety.
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The purpose of this SOP is to define standardized procedures for preparing and submitting clinical trial applications to the South African Health Products Regulatory Authority (SAHPRA) and coordinating with local Ethics Committees (ECs). It ensures compliance with South African regulations, Good Clinical Practice (GCP), and international standards for ethical trial conduct.
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The purpose of this SOP is to provide standardized procedures for the reporting of Suspected Unexpected Serious Adverse Reactions (SUSARs) to regulatory authorities and designated portals. It ensures expedited safety communication and regulatory compliance globally.
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This SOP defines procedures for community engagement in clinical trials involving HIV, TB, and vulnerable populations in South Africa. It ensures participants are informed, culturally respected, and ethically protected, in line with SAHPRA, Ethics Committee (EC), and Good Clinical Practice (GCP) requirements.
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The purpose of this SOP is to describe standardized procedures for the medical management of serious adverse events (SAEs) and intercurrent illness in clinical trials. This ensures participants receive appropriate medical care, while maintaining compliance with regulatory requirements and ensuring timely communication with sponsors and regulators.
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This SOP defines the process for obtaining, managing, and maintaining local import and export permits for investigational products (IPs) and biological samples in South Africa. It ensures compliance with SAHPRA regulations, customs requirements, and international GCP standards to safeguard clinical trial supply chain integrity.
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The purpose of this SOP is to define procedures for reporting and managing pregnancies occurring in clinical trial participants or partners of participants exposed to investigational products (IP). It ensures maternal and fetal safety, regulatory compliance, and accurate documentation.
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The purpose of this SOP is to establish procedures for local pharmacovigilance (PV) reporting and Individual Case Safety Report (ICSR) submissions in South Africa. It ensures compliance with SAHPRA requirements for safety reporting in clinical trials, safeguarding subject safety and maintaining trial integrity.
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The purpose of this SOP is to define processes for ensuring compliance with the Swiss Ordinance on Clinical Trials in Human Research (ClinO) and the Ordinance on Clinical Trials with Medical Devices (ClinO-MD). It outlines the submission, approval, conduct, monitoring, and reporting requirements under Swissmedic, ensuring ethical and regulatory adherence.
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