ICH Publishes New Guideline on Clinical Study Reports
| Posted: 22 June 2012
By Alexander Gaffney
The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) has released a new question and answer document for its E3: Structure and Content of Clinical Study Reports (“The E3 Guideline”) guideline.
Writing on 21 June 2012, ICH said the document was finalized in mid-June as part of Step 4 of its Q&A Procedure process, indicating the document has reached consensus status and is in the process of being adopted by signatory countries.
The E3 Guideline was released by ICH in November 1995 and describes how sponsors should compile and present single, integrated core clinical study reports (CSRs) acceptable to all the US Food and Drug Administration, all EU-member bodies and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA).
In its June 2012 Q&A document, ICH asks and answers seven questions related to the layout of CSRs, the context of the guideline to later ICH publications, whether information contained in a trial master file need to be contained in the CSR, and the terminology used within the CSR.
ICH – E3 Q&A Document
ICH Efficacy Guidelines Page