GCP and the EU Directive in Primary Care

Aims of course
The aim is to introduce the key principles of GCP, the EU Directive on Clinical Trials and the UK legislation on Clinical Trials, and highlight day to day aspects that are specifically significant to primary care clinical research. Participants will gain a clear understanding of how these principles should be applied in the course of primary care research and will have the opportunity to discuss any particular issues which they have encountered.


Programme
The course will cover the following topics:

The 13 principles of GCP & the EU Directive on Clinical Trials as embodied in the medicines for Humans use Act 2006

• Current UK regulations for research involving adults 
• Current UK regulations for research involving vulnerable groups (capacity) 
• Guidelines for consent /assent and their operationalisation in primary care research 
• Pharmacovigilance and safety reporting with particular reference to application and processes in a primary care setting 
• Record keeping and CRFs in primary care research
• Issues particular to conducting research in a primary care setting.
  

• DR Amrit Takhar and Jane Elwood have been runingn a one day course which was accredited by the National Institute of Health Research at Foundation level

• This webpage can be used for pre-course reading and contains copies of handouts relevant to the course

• Learning Outcomes
  Understand the general principles of GCP and regulatory responsibilities to comply with the EU Directive on Clinical trials and the relevant UK legislation and how these relate to the day to day conduct of primary care clinical research within the UK

• Understand the guidelines for consent/assent and particular regulations for vulnerable groups
• Understand the regulations and guidelines on pharmacovigilance and their practical application in a primary care setting  
• Understand the need for meticulous record keeping.

Handout summary

13 principles of GCP

Guidelines for consent (RCN 2006) document (pdf)

GMC Research guidance 2010

Declaration of Helsinki (pdf)

GCP - ICH full document (pdf)

Course slides

Course slides - pdf file to print or download(large 14mb file)