Governance of clinical trials

Delegated responsibilities to NHS Tayside

Responsibilities for pharmacy

The University of Dundee delegates the management, supply, handling, labelling, dispensing and destruction or return of Investigational Medical Products (IMPs) and associated documents to NHS Tayside Patient Services, Pharmacy Department, in accordance with the Standard Operating Procedures of NHS Tayside Patient Services, Pharmacy Department and with TASC Policy 1 on Drug Accountability in Clinical Trials of Investigational Medicinal Products: http://www.tasc-research.org.uk/_page.php?id=238

Laboratory handling of human tissue samples

The University of Dundee delegates all tasks related to the Good Clinical Practice-legislated handling of agreed human samples to NHS Tayside Laboratory Medicine, including for example haematology, biochemistry and bacteriology. This includes sample chain of custody, document control, reporting and management of alert values, equipment validation and calibration, security, training and disaster management.

Maintenance of equipment

The University of Dundee delegates responsibility for maintenance of appropriate University of Dundee clinical trial equipment to NHS Tayside Department of Medical Physics. It is the responsibility of the University of Dundee to alert NHS Tayside Department of Medical Physics to requirements for maintenance and calibration. It is the responsibility of NHS Tayside Department of Medical Physics to keep records documenting maintenance history.

Radiology and nuclear medicine

The University of Dundee delegates responsibility for the radiological procedures that take place in the NHS Tayside Departments of Radiology and Nuclear Medicine on participants in University of Dundee clinical trials to those NHS Tayside Departments of Radiology and Nuclear Medicine. This includes all aspects of radiology and nuclear medicine measurements in these departments as overseen by the NHS Tayside Department of Radiology Governance Committee.

Approval of trials

The University of Dundee delegates the approval process for the start-up and running of clinical trials in Tayside to the TASC Joint Research & Development Office in accordance with TASC relevant standard operating procedures.

Pharmacovigilance & GCP monitoring

The University of Dundee delegates responsibility for pharmacovigilance and GCP monitoring to the TASC Joint Research & Development Office in accordance with TASC Policy 2 on Pharmacovigilance and Safety Reporting and TASC Policy 4 on GCP Monitoring: