The compulsory module is around 5.5 hours and the additional modules will take about 1.5 hours.
The core module acts as the refresher for those who require updated training.
Compulsory core module intended for ALL staff working on CTIMPs
- 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
Module 1: Trial design intended for PIs or those writing protocols
- Protocol development
- Writing associated documents
- Responsibilities of CI & sponsor
Module 2: Submission for approvals for anyone responsible for preparing submissions
- Applications to REC, MHRA, NHS Permission
For details on which (if any) of the additional modules you may wish to attend please contact Karl Shepherd on 01865 572221.