Good Clinical Practice (GCP) training
It is Trust policy that all staff involved in clinical trials of investigational medicinal products (CTIMPs) have to complete GCP training. The Trust accepts certification of training done in the last two years. For any member of staff who has not completed GCP training within the last two years, the R&D Department can offer two types of training: tutor-led and on-line training.
Tutor-led GCP courses
Half-day GCP courses are held at Addenbrooke’s Hospital. The courses provide an informal but intensive overview of the fundamentals of GCP and also introduce The Medicines for Human Use (Clinical Trials) Regulations.
We also offer a refresher course aimed at those who have taken the full course within the last 2 years as well as department-specific training.
- Full training – 3 ½ hours long plus ½ hr Research Governance – cost £60
- Refresher – 2 hours long – cost £30
- GCP Awareness: Documents & Data – 2 hours – £30
- Dept Specific (ex lab) – 2 ½ hours – cost £50
2019 Dates for tutor-led GCP training
To see the dates and venues of courses taking place in 2019, and to subscribe to a course, please download and complete the registration form below, tick the one you wish to attend and return along with the transfer of expenditure form to the R&D team. For more information email Sylvie Robinson or call her on 01223 348490.
The Transfer of Expenditure form allows direct transfer of funds between a Trust department to another only for employees of CUH. If this does not include you and you would like us to invoice your department, then you will need to mark your registration form accordingly (i.e. non CUH NHS FT) and provide us with your departmental budget holder, tel no, email and postal address. If you can provide us with a Purchasing Order please do; it is however not compulsory unless your department requires it.
Online GCP training
Online GCP training is accessible on the Epigeum website. If you have an Addenbrooke’s email address, you can access the course free of charge. Please note that you must register with Epigeum before you can undertake the course. This training is organised in 5 modules:
- Protocol and Associated documents
- Applications, Agreements, Approvals
- Trial Master Files
- Conducting the trial
- Safety Reporting
Please note that you must register on the Epigeum site before you can undertake the course. If you do not have an Addenbrooke’s email address, but hold an honorary contract with the Trust, please e-mail Katerina Tsartsali who can set up an account on your behalf. Please note that you must have prior approval from R&D: email R&D team or call 01223 348490 before you contact Katerina or Epigeum.
Once you have finished your course, you must send a copy of the certificates to Syvlie Robinson in R&D to ensure your training records are updated.
If you experience problems logging in, please contact Sylvie in the first instance.
GCP for labs
Laboratories that are involved in the analysis and evaluation of samples collected as part of clinical trials (drug trials) are regulated by The Medicines for Human Use (Clinical Trials) Regulations 2004.
The Medicines and Healthcare products Regulatory Agency (MHRA) has responsibility for ensuring laboratories are compliant with these Regulations. One expectation is that all laboratory staff involved in the analysis and/or evaluation of clinical trial samples have appropriate Good Clinical Practice (GCP) training. We intend to roll out GCP for labs sessions 3-4 times a year.
For more information and to subscribe to the course, please email R&D team or call 01223 348490.