All clinical trials to be conducted in South Africa are required to be registered with the South African Clinical Trials Register. Registration on this register requires that a trial is approved by a Registered Health Research Ethics Committee and meets the requirements of the Medicine's Control Council.
South African National Clinical Trials Register facilitates registration of trials in accordance with the International Committee of Medical Journal Editors (ICMJE) initiative requiring prior entry of clinical trials in a public registry as a condition for publication.
Sponsors/funders are responsible for ensuring that a trial is fully registered on the South African National Clinical Trials Register before enrolling participants. It is the responsibility of the principal investigator and the trial sponsor to communicate information required for registering the trial. For unfunded trials, the primary investigator takes responsibility for registering the trial.
Multi-site trials and multi-sponsor trials are susceptible to duplicate registration, thus care must be taken in how the trials are registered. For multi-sponsor trials it is the lead sponsor who should take responsibility for registration. It is critical that investigators and sponsors work together to ensure that a trial is registered once and only once for this national register.
Clinical trials are registered with http://www.sanrr.co.za via a web based data entry system called the South African National Clinical Trials Register Toolkit.
Refer to the following sections of this site for further details on: