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CT 1 Revision 2 of October 2005

We apologize for the following errors that have been published in the revised

Detailed guidance for the request for authrisation of a clinical trial on a meidcinal product for human use to the competent authorities, notification of substantial amendments and declaration of the end of the trial

of October 2005.

 

Attachment 1: Information required by new Member States' Competent Authorities

The correct should be:

1.8 Will accept application to CA in English Yes
5.1 Facilities of the trial No
5.2 CV of the coordinating investigator in the MS concerned (for multisenter trials) Yes
5.3 CV of each invstigator responsible for the conduct of a trial in a site in the MS concerned (principal investigator) Yes
6.2 Any insurance or indemnity to cover the liability of the sponsor or investigator Yes


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