The Regulatory Department is responsible for all regulatory compliance required for clinical trials.
The purpose of regulations is to protect the rights of the participants and ensure their safety as well as obtain credible data in order for clinical trials to take place in an ethical way and follow Good Clinical Practice (GCP).
Regulatory bodies that CHRU reports to are:
- Human Research Ethics committee (HREC) at Wits University
- The Medicines Control Council of South Africa (MCC)
- The South African Health Products Regulatory Authority (SAHPRA) and
- The SA Department of Health (provincial and local).
Together with sponsors, the HREC and MCC also monitor trials and may do audits at any time.
The Regulatory Department also:
- Submits documents for approval of the study
- Submits progress reports during the study
- Reports any serious adverse events
- Complies with the financial regulations of funders and
- Ensures adherence to all grant agreements.