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Responsibility of the Chief Investigator

The chief investigator is responsible for negotiating level and cost of support and for gaining approval for support by the PCTU (as specified in obtaining support), and for clearly specifying the role of the PCTU and corresponding financial implications in any funding application.

The PCTU works to a number of JRO standard operating procedures (SOPs) and a number of SOPs specific to the PCTU. The chief investigator is responsible for ensuring that trials linked to the PCTU follow these SOPs. Compliance will be monitored by the PCTU. The responsibilities of the chief investigator as detailed in the ICH Good Clinical Practice guidelines are listed below:

1. Qualifications and agreements (GCP, delegation of trial-related duties)
2. Adequate Resources – time, funding, demonstrate ability to recruit (via pilot etc)
3. Medical care of trial subjects
4. On-going communication with REC/MHRA throughout trial (amendments, annual reports etc)
5. Ensure full compliance with protocol and document deviations and submit amendments to REC
6. Investigational Product (if applicable) - responsible for IMP accountability at site/s (can be assigned to appropriate pharmacist)
7. Randomization Procedures and Unblinding – responsible for following trial’s randomization and blinding/unblinding procedures (if applicable)
8. Informed consent – responsible for following GCP guidelines on informed consent
9. Records and Reports – follow GCP guidelines on CRF and source documentation, maintenance of trial documentation, financial agreements and archiving
10. Progress Reports – provide written summaries to REC (annually or more frequently if requested) and sponsor and REC regarding substantial changes to trial
11. SAEs- responsible for ensuring all SAEs reported to sponsor
12. Premature Termination or Suspension of Trial – Responsible for ensuring trial subjects, institution sponsor and REC are promptly informed if trial ends prematurely or is suspended
13. Final Report – ensure that final report provided to institution, REC, regulatory authorities and sponsor