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<p>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).</p><p> </p><p>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.</p><p>
</p><p>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.</p><p>
</p><p>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.</p><p> </p>
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