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There will always be concerns about the registration of confidential and sensitive data. As already noted, confidentiality surrounding the regulatory process will be respected, and trials whose primary goals are to assess major unknown toxicity or determine pharmokinetics (Phase I trials) are excluded from the trial information being made publically available. (Please note, all clinical trials to be conducted in South Africa, including Phase I trials, must apply for a SANCTR number before a trial can begin.)

If the Principal Investigator/sponsor believes that public disclosure of particular trial information on the SA National Clinical Trials Register will substantially interfere with the timely enrolment of subjects in the clinical trial then a submission to the SA National Clinical Trials Register desk outlining concerns is required. If in agreement with the submission, the Department will ensure that the trail data is not publicly available.

The Department of Health welcomes comments from industry and researchers on this issue, so that it can begin compiling a list of acceptable reasons why basic trial information on certain trials should not be made publicly accessible.

Similarly there is also potential that public registration of clinical trials may impact negatively on innovation. Again applications for exemption will be considered and where appropriate exemptions granted.

Please forward your comments regarding possible reasons for exemptions around innovation, Intellectual Property Rights and participant enrolment.

Contact details for exemption to disclose sensitive information: HlongK@health.gov.za


  

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