What training do I need?
The Joint Research Management Office runs multiple Good Clinical Practice and Governance training courses throughout the academic year. Currently, all courses are online and can be joined via Teams 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 SOP-12b-AD1-JRMO-Sponsorship-review-proportionality-document-v5.0-02.12.2024-FINAL.pdf
Details of the individual courses can be found below:
Good Clinical Practice (GCP) Courses
GCP Refresher
GCP Refresher is a short course to top up knowledge of GCP within the preceding three 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.
Implementation of GCP at Barts Health and Queen Mary
It’s designed for brand new researchers with no prior GCP training, and experienced researchers who are new to Barts Health or Queen Mary.
This course has been purpose built to respect your time while ensuring you gain the necessary practical, organisation specific knowledge that supports safe, high quality research in our organisations.
- JRMO processes,
- Local SOPs,
- How we are addressing previous inspection findings,
- What is expected of you as a Barts Health / Queen Mary researcher.
You’ll leave with a solid understanding of what “good practice” means.
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.