Guidelines and forms

New guidance on medicinal products used in clinical trials
(21.05.2007)

The Commission's Question & Answers on Clinical Trial Documents

Guidelines for good clinical practice
(23.08.2005)

Requests for clinical trials notified after 1 May 2004

Detailed guidance for the request for authorisation of a clinical trial on a medicinal product for human use to the competent authorities, notification of substantial amendments and declaration of the end of the trial, October 2005

Guideline for applications for authorisations of clinical trials of medicinal products on humans, October 2006

EudraCT User Manual - for filling in the applicationform for the request of an authorisation of a clinical trial (pdf-file, opens in a new window)

Form for notification of invoice details concerning clinical trials (e-form)

Requests for clinical trials notified before 1 May 2004
Guideline on notification of clinical trials of medicinal products in humans
Revised January 2004

Forms for clinical trials notified before 1 May 2004

Clinical Trials - composition form - to be used in connection with cataloguing active substances in pharmaceutical specialities (e-form to be filled out online).
(14.02.2005)

Notificationform on a clinical trial, where a complete notification has been submitted by the coordinating investigator (e-form to be filled out online).
(14.02.2005) 

Form for reporting serious incidences or adverse reactions in connection with clinical trials.