The Joint Research Management Office runs multiple Good Clinical Practice and Governance training courses throughout the academic year. Currently, all courses are online using Zoom where there will be a mixture of talks, interactive questions, and breakout groups. Such courses may require pre-requisite training and some pre-reading. More details regarding research-specific training and what is required of researcher personnel can be found in JRMO SOP 34a Researcher Training and SOP 12b Associated Document 2: JRMO Sponsorship review proportionality document.
Details of the individual courses can be found below:
Good Clinical Practice (GCP) Courses
GCP for MHRA-regulated studies
GCP for Non-CTIMPS
The GCP for MHRA regulated studies course (for research relating to drug studies/MHRA regulated studies) and GCP for Non-CTIMPs (for research relating to non-drug studies or Interventional/research studies) are for new or returning researchers. There is no need to do both courses. The courses run over two sessions with talks delivered by JRMO and external speakers.
As a pre-requisite, you will be asked to complete the NIHR eLearning module which will establish a firm foundation focusing on the delivery of research at a site level. Evidence of completing this course in the form of a certificate will be required before acceptance onto these courses.
The JRMO-delivered training will then focus on the information on CI responsibilities, Barts Health and Queen Mary sponsorship requirements and local JRMO processes and SOPs.
GCP Refresher is a short course to top up knowledge of GCP every two years (mandated for MHRA-regulated studies and best practice for non-CTIMP studies). The course aims to focus on updating delegates on GCP hot topics and increasing knowledge of the local and wider-picture guidelines. As this is a refresher course, previous completion of a GCP course is essential.
GCP for Laboratory Staff
GCP for laboratory staff is aimed at laboratory staff and researchers who will be handling laboratory samples from any MHRA-regulated study and is suitable for anyone working in or with a laboratory who is interested in learning more about best practices for handling Samples from a research study. It is suitable for all levels of research knowledge.
The pre-course requirement is attendance to the GCP for MHRA-regulated course, GCP Non-CTIMP or GCP Refresher within the last two years.
This course covers the MHRA guidance on clinical trial samples and EMA reflection paper for laboratories that perform analysis or evaluation of clinical trial samples (EMA/INS/GCP/532137/2010) and GCP. It will outline applicable standards and expectations of a laboratory which will be handling clinical trial samples. This will include topics such as quality systems, organisation of laboratory work, transportation of samples, method validation, processing, facilities and equipment, and the laboratory's relationship with the trial participants.
GCP for Clinical Investigations (ISO14155)
GCP for Clinical Investigations is a short course which will focus on highlighting the difference between ICH GCP and ISO14155 Clinical investigation of medical devices for human subjects - Good clinical practice.
Attendees should be familiar with ICH GCP, the UK's Social Policy Framework and have ideally been working within research for some time.
This session includes talks from JRMO and the Cardiovascular Device Hub staff. The aim of the session is to understand how ISO 14155 GCP differs from ICH GCP and how that will affect your role in research under ISO 14155.
We hope to help you develop an understanding of medical device regulation in the UK and why it is important, understand the practical requirements of running Clinical Investigations in the NHS and guide you on self-learning that should be completed to accompany this course.
Governance Training Courses
- Study set-up
- Managing a study
- Data management and databases
The JRMO Governance team runs three courses dedicated to study coordination of Sponsored studies. The course is aimed at staff working on Barts Health- and Queen Mary-sponsored studies (of any type), who are new to coordination or wish to broaden or strengthen their knowledge. The courses are all run over two sessions, each with talks delivered by JRMO and external speakers. They are designed to work as a three-course series, but can equally be completed as stand-alone sessions.
The pre-course requirement is attendance at a GCP course or Refresher within the last two years.
The study set-up session aims to discuss the steps it takes to get a study from ‘idea’ to ‘reality’, reality being at a point where the project can start, how the JRMO can help you, the different routes the study can take, what documents are needed, why they are needed and how to complete them to a high standard.
The managing a study session aims to discuss the importance of managing a study effectively and the various aspects which can help ensure the smooth and successful running of a study. Topics include site selection, essential documentation, monitoring, risk assessment, and recruitment strategies.
The data management and databases session will focus on the importance of data integrity and how to maintain robust research data. Topics covered include - methods of data collection and storage; developing and implementing case report forms and databases; ongoing data management during and at the end of a trial.