Question to the Department of Health and Social Care:

To ask the Secretary of State for Health, what steps are taken to verify the competence of (a) doctors and nurses and (b) staff of pharmaceutical companies involved in the conduct of clinical trials.

The Medicines and Healthcare products Regulatory Agency (MHRA) expect everyone involved in a clinical trial to be qualified and trained to perform their tasks (as per Schedule 1, part 2 (2) of the Medicines for Human Use (Clinical Trials) Regulations(SI 2004/1031).

Staff of pharmaceutical companies are not “conducting” a trial as defined in the clinical trial regulation (SI 2004/1031 Reg 2 “interpretation”). However, the same Good Clinical Practice principles apply to those involved in clinical trial activities; i.e. they should be qualified and trained to perform their tasks. At sponsor site inspection, inspectors will verify the training records, CV, and job description of selected employees to confirm adequate training has been given.

Sponsors are expected to carry out checks in audits or monitoring to ensure that on completion of training, staff are indeed carrying out their duties according to requirements and/or procedures (these checks should be documented in monitoring/audit reports). Inspectors check the monitoring visit reports to determine non-compliances are adequately followed up and re-training is given to site personnel when necessary.

The voluntary MHRA Phase 1 Accreditation Scheme requires that a Principal Investigator (PI) for a First in Human study has relevant experience and a post graduate qualification in pharmaceutical medicine (such as a Diploma in Pharmaceutical medicine, Diploma in Human Pharmacology, MSc in Clinical Pharmacology or equivalent). An exemption to this requirement has been issued for PI's that do not have a post graduate qualification but are able to demonstrate that they have a significant amount of experience in this field (and are often involved in teaching the post-graduate courses). An application for an exemption is assessed independently by the Faculty of Medicine.