Training
The Research Governance Framework requires that each member of the research team, including those at collaborating sites, is qualified by education, training and experience to discharge his/her role in the study, and that their qualifications are documented.
This applies to the Chief/Principal investigator, and to any staff to whom responsibilities are delegated. The Chief Investigator is responsible for making sure all staff are appropriately trained for their role.
If you do not have a system for recording training given, you are welcome to use the Training Form below:
Template training record
Good Clinical Practice (GCP) and online training
The Joint Research Office organises Good Clinical Practice (GCP) training days on a regular basis.
An online GCP course is available free to employees of the University of Oxford or the Oxford University Hospitals, or anyone working on a study sponsored or hosted by either organisation.
There are five modules:
- Protocol and Associated Documents
- Applications, Agreements and Approval
- Trial Master Files
- Conducting the Trial
- Safety Reporting
Please use the links below for further information on GCP Training and details of how to register:
Face-to-Face Good Clinical Practice (GCP) Training
Note: to be eligible for registration on these courses, you must be employed either by the University of Oxford or the Oxford University Hospitals.
All training will take place in the Joint Research Office, Meeting Room 1, Churchill Hospital.
GCP for Clinical Trials of Investigational Medicinal Products (CTIMPs) as defined by the Clinical Trials Regulations
The compulsory module is around 5.5 hours and the additional modules will take about 1.5 hours.
The Core Module acts as the Refresher for those who require updated training.
Compulsory Core Module intended for all staff working on CTIMPs
- An Introduction to GCP
- Legislation including Data Protection, Human Tissue Act
- Sponsor, Funder, Host Organisation, CI
- Documents required before study start
- Approval, SOPs, Trial Master File, Contracts
- Conducting the Trial
- Eligibility, Informed Consent, IMP and Data Management, Safety Reporting
- Monitoring, Audit, Reports, Ongoing Responsibility
- Web Resources
- Responsibilities
Additional modules
Module 1: Trial Design intended for PIs or those writing protocols
- Protocol development
- Writing associated documents
- Funding
- Responsibilities of CI and sponsor
- Sponsorship
Module 2: Submission for approvals for anyone responsible for preparing submissions
Applications to REC, MHRA, NHS permission
Further information
For details of any additional modules you wish to attend please contact:
Good Clinical Practice (GCP) Online Course
Accredited by the Royal College of Physicians, London.
Introduction
This online course has been designed specifically for professionals employed on non-commercial clinical trials and research studies, such as:
- Chief Investigators
- Monitors
- Study Coordinators
- Data Managers
- Principal Investigators
- Other Investigators
- Study Administrators
- Research Nurses
- QA Managers
- Project Managers
- Pharmacists
Syllabus
The course is available in five modules:
- Protocol and Associated Document
- Applications, Agreements and Approval
- Trial Master Files
- Conducting the Trial
- Safety Reporting
How to book
Note: to be eligible for registration on this course, you should be employed either by the University of Oxford or the Oxford University Hospitals, or be working on clinical research either sponsored or hosted by one of these organisations.
Access is free for eligible persons through registration via University of Oxford, Research Services at the link below.
GCP online course
Complete the online registration form and, once eligibility has been established, a username and password will be issued for access to the course. It can take up to 24 hours for access details to be sent to you.
Registration renewal
For all researchers that have an existing online GCP account that is due for renewal or has expired, you will be required to re-register for the course via:
GCP online course
Researchers will be unable to log into existing accounts and re-take the course quizzes to refresh GCP training due to the architecture of the hosting platform. A new registration must be completed and a new account generated for individuals to refresh GCP training online.
Please contact the CTRG administrator if you have any queries or questions.
Last reviewed:02 December 2021