Introduction to GCP. (Good Clinical Practice). This training is intended for University & NHS research staff involved in clinical research falling under the Clinical Trials Regulations.

Status: This talk is in preparation - details may change

An introduction to GCP
Legislation including Data Protection, Human Tissue Act
Sponsor, funder, host organisation, CI
Documents required before study start – Approval, SOPs, Trial Master File, contracts
Conducting the trial Eligibility, informed consent, IMP & data management, safety reporting
Monitoring, audit, reports, ongoing responsibility
Web resources