Mandatory training, governance and safety management
Good Clinical Practice (GCP) training
The research team of a clinical trial must have attended Good Clinical Practice (GCP) training, according to Medicines for Human Use (Clinical Trial) regulations, the UK's Research Governance Framework and ICH-GCP guidance.
GCP training must be updated at least every 3 years while being actively involved in research, unless the study is commercially sponsored, in which case training must be updated every 2 years.
Within the Hampshire and Isle of Wight region, the GCP courses are delivered by a team of GCP facilitators from the local R&D departments, the University of Southampton and CLRN HIOW. The following NIHR GCP courses are available:
- Introduction to GCP training (classroom-based course, whole day)
- GCP Refresher training (classroom-based course, 3 hours)
- GCP e-learning from the NIHR UK Clinical Research Network
The NIHR UKCRN website has details of all upcoming GCP classroom-based dates and locations across the Hampshire and Isle of Wight region.
If you urgently need to attend GCP training and all HIOW courses are full, you can ask to attend training in another region. Please send an email to the NIHR central training office firstname.lastname@example.org explaining your request and which date and location you'd like to go to.
Book a place on either the Introduction to GCP or the GCP Refresher course or online training
1. Register via the NIHR learning & development website, using the details below. Some of the drop-down menu labels will not entirely fit non-NHS researchers. However, these are mostly for statistical purposes only.
- Network/organisation: CCRN: Comprehensive Clinical Research Network (or for topical networks: Cancer Research Network, UKCRF, MCRN, Stroke Research Network, etc)
- Local network/organisation: CLRN: Hampshire and Isle of Wight (if topical network, please use relevant region)
- NIHR CRN trial title/acronym: Insert either one of your portfolio-adopted project titles or "Research ready"
- Work address: Insert your work postal address with full organisation and department name, mailpoint and postcode
- Line manager: Kelly Adams, CLRN HIOW (for topical networks, please insert name of your network manager)
- Line manager email: email@example.com (for topical networks, use relevant email provided by topical network coordinat)
2. Await NIHR registration confirmation and return to the same website to book a place on a specific date. If you have any queries, please contact RGO assistant Sharon Davies-Dear at Sharon.Davies-Dear@uhs.nhs.uk.
Once you have registered, you will be emailed a reminder before the course date. All your training materials will be provided on the day.
Please bring your own lunch; refreshments will be provided for the whole day Introduction to GCP.
NHS approvals training
UHS R&D department runs a 1.5 hour session on what points to consider when obtaining R&D approval and the next steps afterwards. We highly recommend this session to those new to research or those coordinating research projects.
The session provides a brief overview on: sponsor approval; NRES, REC or University Ethics; using the IRAS form; CSP route and NIHR portfolio; Research Passports, Letters of Access or Honorary Research Contracts; use of EDGE database; SAE reporting; annual reports; Trust Incident reporting.
This is an excellent opportunity to ask the R&D experts for their guidance.
If you are interested, please email Sharon.Davies-Dear@uhs.nhs.uk and she will add your name to the booking list. An email will be sent out as soon as dates and locations are confirmed. We usually run this session 2-3 times per year, places are limited to 20.