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EMEA Guidance – Investigator Signatures on Clinical Study ReportsThe European Agency for the Evaluation of Medicinal Products
Evaluation of Medicines for Human Use
London, 18 October 2001
COMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS (CPMP)
NOTE FOR GUIDANCE ON COORDINATING INVESTIGATOR SIGNATURE OF CLINICAL STUDY REPORTS
DISCUSSION IN THE EFFICACY WORKING PARTY November 2000 TRANSMISSION TO THE CPMP December 2000 RELEASE FOR CONSULTATION December 2000 DEADLINE FOR COMMENTS June 2001 DISCUSSION IN THE EFFICACY WORKING PARTY October 2001 TRANSMISSION TO CPMP October 2001 ADOPTION BY CPMP October 2001 DATE FOR COMING INTO OPERATION April 20027 Westferry Circus, Canary Wharf, London, E14 4HB, UK
Tel. (44-20)74 18 84 00 Fax (44-20)74 18 86 13
E-mail: email@example.com http://www.emea.eu.int
COORDINATING INVESTIGATOR SIGNATURE OF CLINICAL STUDY REPORTSThese notes are intended to provide guidance on the designation of the coordinating investigator who will sign clinical study reports for multicentre studies.
They should be read in conjunction with the Directive 75/318/EEC as amended, by Directive 91/507/EEC.
They are intended to assist applicants in meeting the requirements of that Directive.
I. INTRODUCTIONDirective 75/318/EEC, as amended, by Directive 91/507/EEC, requires that clinical study reports, which form part of marketing authorisation applications, be signed by the investigator. For multicentre studies the signature of all investigators, or the coordinating (principal) investigator is required (reference Directive 75/318 (as amended) Annex Part 4 C 1).
Each Clinical Study Report submitted as part of a Marketing Authorisation Application, or any variation, extension, specific obligation or follow-up measure to one, should be signed by the investigator or in the case of multicentre studies the coordinating investigator.
The Directive does not describe how the coordinating investigator in multicentre studies should be designated. The following guidance has been formulated in order to provide an objective, but flexible method for doing this, in the context of each clinical study.
This guidance is to be applied for studies commencing as of the date of coming into effect of this Note for Guidance.
The guidance reflects that in place, in the first Note for Guidance on Good Clinical Practice, at the time the Directive 9 1/507 was developed and issued.
2. GUIDANCEThe coordinating investigator or the process of designating the signatory coordinating investigator should be defined in the protocol agreed for the study.
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