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EMEA Guidance - Investigator Signatures on Clinical Study Reports

The European Agency for the Evaluation of Medicinal Products

Evaluation of Medicines for Human Use

London, 18 October 2001

CPMP/EWP/2747/00

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 2002
7 Westferry Circus, Canary Wharf, London, E14 4HB, UK

Tel. (44-20)74 18 84 00 Fax (44-20)74 18 86 13

E-mail: mail@emea.eu.int http://www.emea.eu.int

COORDINATING INVESTIGATOR SIGNATURE OF CLINICAL STUDY REPORTS

These 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. INTRODUCTION

Directive 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. GUIDANCE

The 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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