Face-to-Face Good Clinical Practice (GCP) Training

Note: To be eligible for registration on these courses, you must be employed either by Oxford University or the Oxford University Hospitals NHS Trust.

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 & Data Management, Safety Reporting
    -  Monitoring, Audit, Reports, On Going 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 & Sponsor
  • Sponsorship

Module 2: Submission for approvals for anyone responsible for preparing submissions

  • Applications to REC, MHRA, NHS Permission

Dates

ModuleDatesTime
Addit. Module 1 (Trial design)

tbc

tbc

Addit. Module 2

(Document preparation for submission)

tbc

tbc

Compulsory Core Module

26 January 2017

28 March 2017

25 May 2017

27 July 2017

19 September 2017

16 November 2017

12 December 2017

9.30am–4pm

9.30am–4pm

9am–4.30pm

9.30am–4pm

9.30am–4pm

9.30am–4pm

9.30am–4pm

Further Information

For details on which (if any) of the additional modules you may wish to attend please contact Karl Shepherd on 01865 572221.

GCP for Clinical Research Studies (i.e. studies not falling under the Clinical Trials Regulations)

  • An Introduction to GCP
  • Legislation
  • Protocol and Associated Documents
  • Documentation and Study Files
  • Applications, Approvals and Amendments
  • Confidentiality
  • Consent and conducting the study
  • Web Resources
Course NameDateTime

GCP for Clinical Research Studies:

16 February 2017

25 April 2017

20 June 2017

22 August 2017

19 October 2017

9.30am–3.30pm

9.30am–3.30pm

9.30am–3.30pm

9.30am–3.30pm

9.30am–3.30pm

How to Book

Please contact karl.shepherd@admin.ox.ac.uk or tel. 01865 572221 if you would like to attend any of the above courses.

Note: To enable us to provide training free of charge, we regret that we are not able to provide lunch or refreshments.