By the end of this course, participants should be able to:
- An understanding of the EU Clinical Trial Directive and Good Clinical Practice (GCP), the Human Tissue Act (HTA) and Data Protections Act (DPA).
- Understand the role of the regulators including Research Ethics Committee (REC), Medicines and Healthcare Product Regulator Agency (MHRA) and Sponsor of the study is (Queen Mary University of London or Barts Health NHS Trust) and the responsibilities of t
- Attendees will know what approvals and contracts are required before a trial starts
- Attendees will be able to incorporate GCP at their research site
- Attendees will understand the requirement for informed consent, identifying eligible participants and safety reporting
Provided by: Joint Research Management Office