Good Clinical Practice & The Medicines for Human Use (Clinical Trials) Regulations

GCP Training for CTIMP Studies.

A CTIMP is a Clinical Trial of an Investigational Medicinal Product. This is defined as any Clinical Research Study which intends to generate new information about the safety or efficacy of a Medicinal Product.

All CTIMPs carried out in the UK are governed by the Medicines for Human Use (Clinical Trials) Regulations (Statutory Instrument 1031-2004). All staff working on CTIMP studies must be trained in the Principles of Good Clinical Practice and the Regulations and their application.

This course will be appropriate to you if you are working or expect to be working on one or more CTIMP(s). If you are expecting to be working on both CTIMP and non-CTIMP studies this is also the appropriate course for you, as it covers the general guidance and principles that apply to both types of research. However, if you are not expecting to work on any CTIMPs now or in the future, you may find the Non-CTIMP course more applicable to your work.

If you think that this is the appropriate course for you, please select the booking form below.

CTIMP Booking Form

If you are unsure or want further guidance on appropriate training, please feel free to contact us.

Course Outline:

This half-day course will provide those staff involved in the conduct of CTIMPs an informal but intensive overview of the fundamentals of Good Clinical Practice. The training is based on the principles of GCP and The Medicines for Human Use (Clinical Trials) Regulations SI. 2004/1031 and subsequent amendments, which have transposed the EU Clinical Trials and Good Clinical Practice Directives into UK law.

By the end of this course you will be able to:

  • Understand the evolution of GCP including the principles of GCP, the fundamentals of the EU Clinical Trials Directive and the implementing Regulations
  • Formulate strategies for incorporating the principles of GCP at the sponsor/trial site
  • Be aware of the changes to the ethics process and the definition and responsibilities of the Sponsor and Investigator
  • Understand the requirements for informed consent and safety reporting
  • Define an Essential Document and understand the requirements for clinical trial documentation and data quality at the trial site
  • Understand what an auditor/MHRA inspector will look for when visiting a site

Accreditation:

This course has been accredited 4 CPD points from the Royal College of Physicians.

This course also meets the minimum criteria for GCP training as set out by the pharmaceutical group Transcelerate.

Courses as of the 14th of June 2017 have met the new minimum criteria, in line with the R2 revision to the ICH-GCP E6 guideline.

The additions to the text of ICH E6 are minor and essentially bring it into line with other guidance and regulation already covered in our courses. Therefore, if you have previously attended training with us and are not due an update, we do not recommend that you attend additional training just to gain an R2 update. Instead, you can simply read, initial and date this update document and file a copy with your existing GCP certificate: ICH R2 Summary V1.1 24-10-17 (pdf 600kB).

Costs:

This course is available for KCL, IoPPN, KCH, Guy’s, St Thomas’ and SLaM staff. This training is supported by the King's Health Partners Clinical Trials Office; therefore there is no charge to delegates.

 Dates & Venues:

  • Thursday 3rd May 2018
    Full - Waiting List Available
    Seminar Rooms A&B
    SGDP Centre
    Denmark Hill Campus
    12:00-16:30

  • Wednesday 9th May 2018
    Seminar Room 9
    IoPPN
    Denmark Hill Campus
    12:30-17:00

  • Thursday 7th June 2018
    Meeting Rooms 1-3
    KHP-CTO, 16th Floor, Tower Wing
    Guy's Hospital
    09:00-13:30