Trusted Resource for Clinical Trials, Protocols & Progress
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.
Click to read the full article.
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.
Click to read the full article.
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.
Click to read the full article.
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.
Click to read the full article.
