Wellcome Trust Clinical Research Facility Edinburgh
| Wellcome Trust Clinical Research Facility Edinburgh | |
|---|---|
| Western General Hospital Crewe Road South Edinburgh EH4 2XU | Telephone : 0131 537 2591 Website : Wellcome Trust Clinical Research Facility Edinburgh |
| Education and Training : Good Clinical Practice & the EU Directive. 17/06/2010 | |
| Description: | The Medicines for Human Use (Clinical Trials) Regulations 2004 now implement the EU Clinical Trials Directive (2001/20/EC) as law in the UK. This course is designed to provide an overview of the requirements of these regulations. Research professionals involved in conducting clinical trials sponsored by NHS Lothian and the University of Edinburgh are required to demonstrate attendance at this course or demonstrate evidence of similar training. Course outline: * provides a history of clinical trials and the development of GCP * deciding what is a clinical trial as per EU Directive discussion of informed consent - the ethical and statuary imperatives with particular reference to vulnerable groups * responsibilities of research personnel and the process of obtaining approvals to conduct clinical trials * overview of the 14 principles of GCP * pharmacovigilance - definitions and a series of case studies are discussed * monitoring exercise - group exercise to highlight examples of breaches of GCP and documentation discrepancies that can occur. |
| Contact: | Dr Jane Ilsley |
| Education Programme Manager | |
| Telephone: | 0131 537 3355 |
| Email: | wtcrf.education@ed.ac.uk |
| Venue: | Wellcome Trust Clinical Research Facility, Western General Hospital, Edinburgh. |
| Fees: | £55.00 NHS Lothian/University of Edinburgh £90.00 Other |
| Website: | http://www.crts.org.uk/CRF/Edinburgh/Lists/Courses.aspx |