On 3rd March members of the Clinical Research Compliance Team, along with colleagues from Trials Units PC-CRTU and CRTU, attended the MHRA Good Clinical Practice Symposium in Hammersmith, London (http://www.mhragcp.co.uk/page/view/about/). The MHRA conducts inspections to ensure compliance with clinical trials regulations and the symposium is designed to support the work the University does in the area of clinical trials.
Presentations on the day covered:
- Clinical Trial Authorisation applications
- An update on the new Clinical Trials Regulations due in 2016
- CSV and Data integrity
- Multi-site studies
- Serious Breaches
- Common Inspection findings, and
- A Q & A session with the panel of GCP Inspectors.
- It was interesting to hear about how future planned changes in regulations will affect us and to be able to reflect and learn from shared best practices, and it was also very useful to validate the work we have been doing in assuring the quality of our clinical trials here at the University.
If you would like to know more details about the Symposium please do contact us at rktoffice [at] contacts.bham.ac.uk