Good Clinical Practice & Good Research Practice Training

If you require to complete or update a course please email the training team at gram.randdtraining@nhs.scot

What is Good Clinical Practice (GCP) / Good Research Practice (GRP)?

Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting studies that involve human participants. Attending the relevant GCP or Good Research Practice (GRP) course is an essential requirement for any researcher involved in commercial or non-commercial studies. Compliance with GCP principles provides assurance that the rights, safety and well-being of research subjects are protected and that the results of the study are credible.

Good Clinical Practice (GCP) or Good Research Practice (GRP)?

How do you know if either the GCP or GRP courses is relevant to you? Please contact the training team for confirmation gram.randdtraining@nhs.scot

How often do I require the training?

It is highly recommended that GRP/GCP training is updated with a refresher every 2 years. More details can be found in SOP-QA-34 at our SOPs and Templates page.

Please note that if the duration since the last Good Clinical Practice (GCP) or Good Research Practice (GRP) Introduction or refresher training exceeds *three years*, a researcher must complete the full Introduction to GCP training again, rather than the refresher training.

It is recommended that researchers attend face to face sessions where possible, but there are on-line options available where applicable.

How do I know when I need to Update?

It is important to keep your GCP/GRP training up-to-date. If you can not remember when you previously completed GCP/GRP training, here are some tips:

• If you previously completed an E-Learning session, you may have a dated certificate in your Inbox to refer to (search for a PDF attachment containing 'Good_Clinical_Practice').
• If you or a member of your team has Scotland ReDA login, this stores previous certificates. (https://scotland.reda.org.uk/)
• Email gram.randdtraining@nhs.scot to check when you completed your previous training.
• Perhaps designate a team member to ensure this training is kept up-to-date.

Upcoming course dates

Good Clinical Practice (GCP) courses

The following courses are available for those requiring an Introduction to GCP for CTIMPs or a GCP Refresher course.

NRS Introduction to Good Clinical Practice (CTIMPs)

This one day course is designed either for those who have not studied Good Clinical Practice (GCP) before or for those who have studied it more than two years ago. While the principles of GCP that are covered in the course are common to a wide range of different types of clinical research, the course does focus on the drug trial specific legislation. However, it also tries to promote the ‘GCP-mindset’ needed to satisfy inspectors and auditors, and would therefore be useful to all clinical researchers. The course is presented as a practical introduction to the subject and consists of a mixture of short lectures interspersed with practical activities, culminating in a monitoring workshop where delegates are asked to work in small groups and review trial paperwork in the role of the monitor. This activity allows a lot of the more abstract concepts that have been discussed throughout the day to be brought to life.

This ICH E6 GCP Investigator Site Training meets the Minimum Criteria for ICH GCP Investigator Site Personnel Training identified by TransCelerate BioPharma as necessary to enable mutual recognition of GCP training among trial sponsors.

NRS Good Clinical Practice CTIMPs (Update)

This course is relevant for those who are conducting or supporting Clinical Trials of an Investigational Medicinal Products (CTIMPs) and who have previously undertaken a GCP course. It is suitable for those who require an update to provide evidence of having maintained and updated their knowledge of GCP. Attendance at the half day update course requires you to have undertaken GCP training within the past two years. The course is compliant with Transcelerate requirements.

Topics include:

• UK legislation – Statutory Instrument
• What’s new in regulations and frameworks
• Quality Systems
• Record Keeping
• Safety Reporting
• Computer System Validation
• Principles of GCP.

This ICH E6 GCP Investigator Site Training meets the Minimum Criteria for ICH GCP Investigator Site Personnel Training identified by TransCelerate BioPharma, Inc. as necessary to enable mutual recognition of GCP training among trial sponsors.

Please contact gram.randdtraining@nhs.scot for access details.

NIHR Good Clinical Practice (GCP) Refresher eLearning

This is an online equivalent of the face-to-face update course (see above) and is suitable for anyone who has already completed the NRS Introduction to Good Clinical Practice OR the online NIHR Introduction to GCP (above). This option is available for those who are required to revalidate their certificate and are unable to attend a face-to-face update. It is recommended to allow around 4 hours to complete this course, however, this can be different dependent on the individual delegate. Please contact gram.randdtraining@nhs.scot for more details.

Please note the GCP for CTIMP update cannot be used to update a non drug (GRP) course. If you require to switch training, due to commencing drug study research with CTIMPs, or due to unavailability of  our non drug GRP course, then the NRS Introduction to Good Clinical Practice OR the NIHR Introduction to Good Clinical Practice (GCP) eLearning MUST be completed first.

Virtual Introduction to GCP (CTIMPs) and GCP (CTIMPs) update

Glasgow Clinical Research Facility are delivering virtual face-to-face training for the Good Clinical Practice (GCP) update. These courses are available on various dates and recommended for those who would prefer to under-take the GCP Update training in a virtual face-to-face setting, rather than via e-Learning. The courses are free to NHS Grampian and University employees. For dates click on this website: Course Browse | NHS Research Scotland | NHS Research Scotland 

Certificates for any of the above training must be emailed to the R&D training department for our records at the above email address.

Good Research Practice (GRP) for Health Care Research (non-drug) courses

This will suit any researcher involved in studies that do not involve investigational medicinal products. It is suitable for studies that are observational, qualitative, using blood or tissue, analysing data from medical notes and many more. This course will incorporate the principles of GCP through lecturing and interactive activities. Key topics include The UK Policy Framework for Health & Social Care Research, Informed Consent, Delegation & Responsibility, Data Protection and Monitoring.

Good Research Practice for Health Care Research (Update) (non-drug)

This course is for any researcher who has previously completed the full Good Research Practice for Health Care Research (known as GRP and formerly known as GCP Core for Researchers) course and requires revalidation. The course will cover the UK Policy Framework for Health & Social Care Research incorporating the principles of Good Clinical Practice using a combination of lecture and interactive workshops. Topics covered include The UK Policy Framework for Health & Social Care Research, Roles & Responsibilities of those involved in the research process, Documentation and Quality Assurance.

Email us at gram.randdtraining@nhs.scot for any assistance.