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 What is to be registered? Minimize

The South African National Clinical Trials Register covers the full spectrum of clinical trials including trials on pharmaceuticals, devices, surgical procedures and those looking at psychosocial and health system interventions.

The SA National Clinical Trials Register uses the same definition for a clinical trial as proposed by the ICMJE : “Any research project that prospectively assigns human subjects to intervention and comparison groups to study the cause and effect relationship between a medical intervention and a health outcome.” Whereby ‘medical intervention’ refers to any intervention used to modify a health outcome, including drugs, surgical procedures, devices, behavioural treatments, process of care changes etc. Registration requires that the trial has at least one prospectively assigned concurrent control or comparison group.
Although it will be a requirement for all trials to be registered on the SA National Clinical Trials Register, to ensure innovation and competitiveness is not compromised those trials whose primary goals are to assess major unknown toxicity or determine pharmokinetics (Phase I trials) are excluded from being made publicly available. All trials however whose primary purpose is to affect clinical practice (Phase III) will be publicly accessible. Sponsors/Principal investigators can apply for an exemption for the public recording of Phase II trials if there is potential for innovation, competitiveness, intellectual property rights to be compromised.


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