Clinical trials: Mock applications

From 1 November 2007, letters from the MHRA relating to clinical trial submissions will not be signed. The wording and format of letters from the MHRA relating to clinical trial submissions will also be modified from this date. This is in line with MHRA policy.


The MHRA has produced guidance which includes a mock application for a fictitious product (198Kb).  The information presented illustrates the quantity and level of detail expected where it is available. A mock application for a fictitious biotechnology product (175Kb) is also available. This is provided to give an indication of the type of information expected for a product of this type in early stage development. A copy of a completed application form (245Kb) and a protocol overview (103Kb) is also provided. The protocol overview is only intended to give an outline of the proposed trial and should not be regarded as a model for a protocol summary.

 


Page last modified: 07 February 2008