Regulatory approvals need to be in place before a study can start. Most regulatory bodies require annual/biannual progress reports for ongoing approval. Study amendments and updates must be submitted for approval (or sometimes acknowledgement) prior to implementation at the site.

There may be many important stakeholders who need to give approval (or be consulted) depending on the type of research study or the particular participant population. Please see summary below, or contact the CRC if you need further advice on which stakeholders may need to be approached for approval.

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GCP

Drug/Device Trial needs:

  • National
  • Ethics
  • MCC
  • Facility

Clinical Research needs:

  • National
  • Ethics
  • Facility

UCT research teams who are finding it difficult to obtain feedback on submissions should also contact the CRC who may be able to intervene on their behalf.

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