Good Clinical Practice and the Medicines for Human Use (Clinical Trials) Regulations (Refresher)

Prerequisite: Previous attendance of the GCP for CTIMPs course or equivalent introductory GCP course.

All staff involved in Clinical Trials of Investigational Medicinal Products (CTIMPs) must refresh and update their knowledge of GCP and the Regulations at least once every two years.

For anyone involved in trials sponsored, co-sponsored or hosted by any of the Partner Organisations (GSTFT, KCH, KCL, IoPPN or SLaM) who has previously completed the Half-Day GCP Course, or an equivalent course at another organisation, the Refresher Course is the recommended way to comply with this directive.

Please note that the refresher course presumes an existing level of knowledge around research - including knowledge of common acronyms and terminology. If you have not recently been involved in research, we recommend revisiting the Introductory CTIMP course.

Course Outline

  • Refreshing your knowledge of;
    • Regulations and Amendments
    • Informed Consent
    • Pharmacovigilance
    • Essential Documents

  • Booking:

    To book a Refresher using the online booking form, please click below:


    If there are six or more people in your department who are working on CTIMPs (Clinical Trials of Investigational Medicinal Products) and require a Refresher at around the same time, we may be able to arrange a departmental training session - at a time and place to suit you. If you think that this would be of use to your department, please select the form below.

    Please note: If you require training on a specific date, please ensure that you request it well in advance - as this will increase the likelihood of a trainer being available.


    If you are not going to be working on any Clinical Trials of Investigational Medicinal Products, you might find that the Non-CTIMP course is more relevant to your practice.


    If you have any questions, please click below to contact the training team by e-mail:


    Accreditation:

    Our open Refresher courses have been accredited 2 CPD points by the Royal College of Physicians.

    The 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:

    • Monday 16th September 2019
      Park Room,
      Guy's and St. Thomas' Education Centre,
      75-79 York Road, Lambeth
      14:00-16:00

    • Thursday 17th October 2019
      Meeting Rooms 1-3,
      16th Floor, Tower Wing,
      Guy's Hospital
      14:00-16:00

    • Wednesday 6th November 2019
      Seminar Room A&B (ground floor),
      Social, Genetic and Developmental Psychiatry Centre,
      Denmark Hill Campus
      14:00-16:00

    • Wednesday 11th December 2019
      Meeting Rooms 1-3,
      16th Floor, Tower Wing,
      Guy's Hospital
      10:00-12:00