Resources
The PCTU has developed data management guidelines which it expects trials supported by the unit to work to. There are a number of other sites which researchers may find useful.
The MRC/DH clinical trials toolkit provides practical help for those trying to meet the requirements of the UK Medicines for Human Use (Clinical Trials) Regulations 2004, which implement the EU Clinical Trials Directive in the UK.
An online module has been added to IRAS to guide new users through IRAS. The module, which is free, explains how IRAS is structured and guides users through how to prepare and make applications using IRAS.
Other Useful Information
European Agency for the Evaluation of Medicinal Products
Institute of Clinical Research
MRC Guidelines for Good Clinical Practice
National Research Ethics Service for guidance on ethics applications including a CV template
Understanding Clinical Trial booklet
