Oversight and Monitoring in Clinical Trials Guideline: March 2021

SAHPRA requires sponsors to monitor the conduct and progress of their clinical trials because effective monitoring of clinical trials by sponsors is critical to the protection of human participants and the conduct of high-quality studies.

It is expected of Sponsors of clinical trials involving human medicines, biological products, medical devices, and or other combinations, to provide oversight to ensure adequate protection of the rights, welfare, and safety of human participants and the quality of the clinical trial data submitted to the South African Health Products Regulatory Authority (SAHPRA). To this effect, SAHPRA has drafted a guideline for the oversight and monitoring of clinical trials.

Find at the link below the guideline launched in March 2021 that gives oversight in the monitoring in clinical trials:

  • This guideline focuses principally on monitoring, which is one aspect of the processes and procedures needed to ensure clinical trial quality and participant safety.

  • Monitoring is a quality control tool for determining whether study activities are being carried out as required so that deficiencies can be identified and corrected.

  • SAHPRA's stances that Monitoring or oversight alone cannot ensure quality. Rather, quality is an overarching objective that must be built into the clinical trial enterprise.

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