Good Clinical Practice Training


Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting studies that involve human participants. Attending GCP courses are an essential requirement for any researcher involved in commercial or non-commercial studies. Compliance with GCP provides assurance that the rights, safety and well-being of research subjects are protected and that the results of the study are credible. GCP training should be updated every 2 years, more details can be found in SOP-QA -34 V1 by clicking here

 

Courses are held in Room 115 (first floor) of the Health Sciences Building or the Suttie Centre, both Foresterhill. A map can be sent, on request, alongside confirmation of course booking.

 

NRS Introduction to GCP (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.

 

Upcoming dates:

        2016 dates

  • Monday 8th February                 09:00 - 16:30       Room 115 Health Sciences Building
  • Friday 13th May                         09:00 - 16:30       Room 115 Health Sciences Building
  • Wednesday 24th August             09:00 - 16:30       Room 115 Health Sciences Building
  • Monday 14th November             09:00 - 16:30       Room 115 Health Sciences Building

 

Please email us at: nhsg.randdtraining@nhs.net to enquire about availability and receive a registration form. 

 

Online NIHR Introduction to GCP (CTIMPs)

This is an online equivalent of a full day face-to-face course (see above). Anyone conducting or supporting clinical trials involving CTIMPs (Clinical Trial of Investigational Medicinal Products). This option is also 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 at least 4 hours to complete this course, however, this can be different dependent on the individual delegate. 

Please email us at: nhsg.randdtraining@nhs.net for online registration details.

 

GCP CTIMPs (Update) 

This course is an update for those who have previously completed a full NRS Introduction to GCP (CTIMPs) or an online NIHR Introduction to GCP (CTIMPs).

Key topics include:

  • Responsibilities, Approvals Process & Trial Master Files
  • Pharmacovigilance
  • Quality Tools
  • MHRA Inspections

The next available course is on Wednesday 9th March 2016 from 12:45-16:00 in the Med Chi Building

Please email us at: nhsg.randdtraining@nhs.net to enquire about availability.

 

GCP Core for Researchers (non-drug)

The course is designed for those involved in studies that do not involve investigational medicinal products (IMPs). It is suitable for studies that are: observational; qualitative; using blood or tissue; analysing data from medical notes (and many more).

The course covers principles of GCP through lecturing and interactive activities. Key topics include:

  • The Research Governance Framework
  • Roles & Responsibilities
  • Informed Consent
  • Study Documentation
  • Quality Assurance

Upcoming dates:

        2016 Dates

  • Monday 25th January                    09:30 - 12:30          Suttie Centre, room 210
  • Monday 22nd February                 13:00 - 16:00          Suttie Centre, room 233
  • Tuesday 1st March                        13:00 - 16:00          Room 115 Health Sciences Building
  • Thursday 3rd March                      09:30 -12:30           Suttie Centre, room 210
  • Wednesday 20th April                   09:30-12:30            TBC

Please email us at: nhsg.randdtraining@nhs.net to enquire about availability and receive a registration form.

 

GCP Update for Researchers (non-drug)

This course is an update for anyone involved in studies that do not involve investigational medicinal products (IMPs) and who has previously completed a full GCP Core for Researchers (non-drug) course or an online NIHR Introduction to GCP (CTIMPs).

Key topics include:

  • The Principles of GCP
  • The Research Governance Framework
  • Recent and pending changes

 

Upcoming dates:

         2016 Dates

  • Thursday, 11th February             13:30 - 15:00           Suttie centre Room 210
  • Monday 22nd February              09:30 - 11:00           Suttie centre room 233
  • Monday 7th March                     09:30 - 11:00           Suttie Centre room 210
  • Thursday 2st April                       13:30-15:00            TBC

Please email us at: nhsg.randdtraining@nhs.net to enquire about availability.