Terms and conditions
The Medicines and Healthcare products Regulatory Agency is the UK regulatory authority for clinical trials with medicines.
In preparing the Clinical Trials Tool Kit, the MRC, DH and their advisors have done their best to make sure that nothing recommended here is inconsistent with the law or regulatory guidelines.
They have done their best to
• identify the regulatory requirements
• distinguish between the regulatory requirements and other kinds of good practice.
Unless otherwise indicated, the advice in the Clinical Tool Kit does not have the status of a formal requirement of the MHRA, the Department of Health or the Medical Research Council.
It is your responsibility to ensure your trial complies with the regulations and to consult the MHRA or other authorities where you are uncertain. Neither the MRC nor the DH accept liability for failures to comply with the regulations as a result of the use of the Clinical Trials Tool Kit.
Any document or link may be changed without notice. The Tool Kit refers in good faith to a number of documents authored by others than the Joint MRC/DH Project on the EUCTD. We accept no liability for the content of material published by others.
