Good Clinical Practice (GCP) For Clinical Trials Involving Investigational Medicinal Products

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What is Good Clinical Practice (GCP)?

“GCP is an international, ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects”. (ICH-GCP)

GCP training is a key requirement for anyone involved in the conduct of clinical research.

Everyone involved in the conduct of clinical research must have training to ensure they are best prepared to carry out their duties. This legislative requirement set out in The Medicines for Human Use (Clinical Trials) Regulations 2004 (SI 2004/1031) applies to all trials involving Investigational Medicinal Products undertaken within England.

What this means at University Hospitals of Leicester

The following sessions are aimed at researchers who will be undertaking Clinical Trials involving Investigational Medicinal Products.

All new researchers must attend a face-to-face GCP course. For those not new to research, an eLearning course is also provided but this is a refresher course only.

It is currently a requirement that all researchers attend a GCP course every three years. After attending the initial face-to-face course, one online refresher course can be completed before attendance at another face-to-face session is required.

What training do we provide?

We provide a face-to-face Good Clinical Practice (GCP) for studies involving Investigational Medicinal Products

Good Clinical Practice (GCP) Training for CTIMP Research (OCB) eLearning refresher.  At the present time this can only be accessed via HELM. Researchers who are unable to access HELM will need to re-attend a face to face session  at the end of 3 years.

Please note HELM is not currently able to issue certificates. Once course successfully completed email the R&I Training team RITraining@uhl-tr.nhs.uk to request a certificate. Please allow up to 7 days for a response.

Both of these sessions are valid for 3 years

 How do I book a place on the GCP sessions?

For researchers undertaking National Institute for Health Research (NIHR) Portfolio studies, you can also access GCP and Consent training through the Training and Development Team of the Clinical Research Network: East Midlands.

For staff who have access to HELM please book via this system.

For staff who are unable to access HELM,  booking can be made via the link below.

Please view the calendar on our Training and Development page to see upcoming sessions and dates.

For further information and to BOOK a place on one of the sessions please contact RITraining@uhl-tr.nhs.uk

If you experience any problems accessing the HELM system please log a call with the HELM Helpdesk in the first instance.

For researchers undertaking National Institute for Health Research (NIHR) Portfolio studies, you can also access GCP and Consent training through the Clinical Research Network: East Midlands.

If you are an external candidate or have any questions about individual training needs, please complete the form below: