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Good Clinical Practice (GCP) training

 

It is policy of the Trust that all Research Nurses and all staff involved in clinical trials of investigational medicinal products (CTIMPs) have to complete GCP training. The Trust accepts certification of training done in the last two years. For any member of staff who has not completed GPC training within the last two years, the R&D Department can offer two types of training: tutor-led and on-line training.

Tutor-led GCP courses

Half day GCP courses are held at Addenbrooke’s Hospital and led by Tanya Symons. They provide an informal but intensive overview of the fundamentals of GCP and also introduce The Medicines for Human Use (Clinical Trials) Regulations.

The courses run by Tanya are now Pfizer accredited, download a guide for investigators here.

We also offer a refresher course aimed at those who have taken the full course within the last 2 years.

Full training – 3 ½ hours GCP training plus ½ hr Research Governance

Refresher – 2 hours

For more information and to subscribe to the course, please contact sylvie.robinson@addenbrookes.nhs.uk or call 01223 348490

Dates of GCP training 2012

 

June 2012
Monday	11		8.30		12.30			Seminar Room 5 Clinical School												Half day course
Monday	11		13.00		15.15			Seminar Room 5 Clinical School												Refresher course
Tuesday	12		8.30		12.30			ATC Seminar room 3												Half day course
September 2012
Monday	10		13.00		15.15			Alice Fisher Lecture Theatre												Refresher Course
Monday	10		08.30		12.30			Clinical School Seminar Room 3												Half day course
Tuesday	11		8.30		12.30			Clinical School Seminar Room 3												Half day course

 

GCP Training Calendar 2012 (48 KB)

 

On-line GCP training

 

Online GCP training is accessible via the web, see details below.
The training is organised in 5 modules:

- Protocol and Associated documents
- Applications, Agreements, Approvals
- Trial Master Files
- Conducting the trial
- Safety Reporting

 

On-line GCP training is organised by Epigeum.  If you have an Addenbrooke's email address, you can access the course free of charge via their website. Please note that you must register with Epigeum before you can undertake the course.

 

If you do not have an Addenbrooke's email address, but hold an honorary contract with the Trust, please e-mail james.connor@epigeum.com who can provide you with a user name to self-register on the system.

 

Once you have finalised your course, you must send a copy of the certificates to sylvie.robinson@addenbrookes.nhs.uk.

Essential Documents training

The guidelines for the management and the conduct of clinical trials include the management of appropriate study documentation.

 

The Trust is hosting a new course which is aimed at site staff either new to their role or who want a better understanding of the principles of GCP specifically relating to study documentation.

 

This course will take place on Thursday 23rd February 2012.

 

Time: 8.45 to 12.30

Location: Clinical School seminar room 6

Cost: £ 30.-

 

Please read the flyer for more details together with an agenda for this session. To register, please complete the below registration form and also a Transfer of Expenditure request form.

 

FLYER Docs and Recruitment 72kB

Agenda 23 February 128 kB

Registration form 42 kB

 

GCP for labs

 

Laboratories that are involved in the analysis and evaluation of samples collected as part of  clinical trials (drug trials) are regulated by The Medicines for Human Use (Clinical Trials) Regulations 2004.

 

The Medicines and Healthcare products Regulatory Agency (MHRA) has responsibility for ensuring laboratories are compliant with these Regulations. One expectation is that all laboratory staff involved in the analysis and/or evaluation of clinical trial samples have appropriate Good Clinical Practice (GCP) training. We intend to roll out GCP for labs sessions on a 3 to 4 times a year basis.

 

For more information and to subscribe to the course, please contact sylvie.robinson@addenbrookes.nhs.uk or call 01223 348490

 

 

 

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