Good Clinical Practice For Research Studies That Do NOT Involve Investigational Medicinal Products

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Good Clinical Practice (bitesize) For Research Studies That Do NOT Involve Investigational Medicinal Products

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 is laid down by the relevant regulatory authorities, covering all research in the NHS in England.

What this means at Leicester’s Hospitals

It is currently a requirement within Leicester’s Hospitals that all researchers attend a GCP session every three years.

For studies not sponsored by Leicester’s Hospitals, it is recommended that you check with your Sponsor with regards to their GCP training requirements and also refer to the Host training SOP requirements.

The following sessions are aimed at researchers who will be undertaking research that does NOT involve investigational medicinal products. Please note, if you later wish to work on a clinical study that involves investigational medicinal products (CTIMP), further training will be required.

What training do we provide?

From July 2016, the existing GCP1 training was replaced by 4 bite-size Principles of Good Clinical Practice sessions. If you are new to research, you will need to attend two sessions in the first instance. Those who have completed previous training are only required to attend one session (although researchers are welcome to attend more if they wish). It is recommended that the chosen session is appropriate to your role in the research study.

The training is valid for 3 years. It is recommended that the decision as to which sessions are appropriate for you to attend should be taken in collaboration with the Principal Investigator to best facilitate the research.

More information on training requirements can be found in the training SOP, S-1008.

The following bite size sessions will be offered:

Session 1 – Documentation, Data Management, Quality Assurance & Quality Control.

The session covers why and how researchers are required to document their research practices, case report completion, documentation within participant medical records and the types of quality assurance/control systems that are utilised within a research study.

Session 2 – Essential Documentation for the Conduct of a Research Study.

This covers what essential documents are, their purpose in relation to a research study, how they are maintained within a Trial Master File/Investigator Site File throughout the study lifecycle.

Session 3 – Sample Management.

This covers why and how researchers are required to undertake management and chain of custody for samples collected for research purposes. Confirmation of consent (where applicable) and tracking of sample collection, preparation, analysis, storage, transfer/receipt and destruction.

Session 4 – Serious Adverse Event Reporting. This covers the reasons why safety reporting is important, the requirements for reporting events and the process involved in reporting serious adverse events.

The email for notification of completed training is valid for 3 years, so must be retained as proof of completion.

 How do I book a place for the bite size sessions?

These sessions cannot be booked via e-UHL. 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.

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.

The University of Leicester provides GCP-1 (GCP for non-CTIMP studies) training, which is available to all university and hospital staff. This training session is primarily aimed at Chief and Principal Investigators but will be open to all study staff should spaces be available. It is also suitable to those new to research or those refreshing their GCP-1 training.

To book a place please contact uolsponsor@le.ac.uk

University of Leicester GCP training dates and venues.