The SA National Clinical Trials Registry

December 14, 2011

FAQ's & Answers, News

The SA National Clinical Trials Registry

Q: What is the SANCTR and why is it important to the researcher?

A: The South African National Clinical Trials Register (SANCTR) covers the full spectrum of clinical trials and provides the public with updated information on trials conducted in SA.

The SANCTR forms part of international calls for making trial information publicly available. The International Committee of Medical Journal Editors, which includes peer reviewed journals from around the world, made a statement that from 1 Jul ’05 no trials will be considered for publication unless they are included on a research register. In Nov ’05 the DOH issued a notice that as from the
1st Dec. 2005 all new clinical trials to be conducted in the country must be registered.

Although it is a requirement for all trials to be registered on the SANCTR, 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.

Reference: www.sanctr.gov.za/