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:
Together with sponsors, the HREC and MCC also monitor trials and may do audits at any time.
The Regulatory Department also: