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8EudraCT

Before Initiation

Every clinical trial conducted in Europe must be announced to the European Medicines Agency (EMA) using the European Union Drug Regulating Authorities Clinical Trials (EudraCT) database system. The EudraCT database comprises all clinical trials conducted in the European Union since 1 May 2004.

The health authorities of the Member States, which grant the approval and the supervision of clinical trials, use this database, created and maintained by the EMA. Another task of the EudraCT is to provide sponsor-investigators with a grasp of the basics of the approval application, the recommended statement from the study site’s Ethics Committee, information on the termination of a clinical study, as well as hints to carry out inspections.

The assigned EudraCT Number is the central identification for a clinical trial in Europe and is to be stated in all correspondence with authorities and the Ethics Committee.

Regulatory Reference

! Detailed guidance on the collection, verification and presentation of adverse reaction reports arising from clinical trials on medicinal products for human use

! 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

! Detailed guidance on the application format and documentation to be submitted in an application for an Ethics Committee opinion on the clinical trial on medicinal products for human use

! Detailed guidance on the European clinical trials database (EudraCT database)

Responsibilities

Request for a EudraCT Number

Prior the submission of the clinical trial to the health authority, the sponsor-investigator must visit the website of European Clinical Trials Database to obtain a unique EudraCT Number (please review the Operational Instructions for detailed information).

Labelling

The EudraCT Number is strongly recommended to (in most cases, is required to) be used prominently in the following:

• All covering letter headings as well as other (including electronic) correspondence with the Competent Authority

• All of the documents sent to the Ethics Committee before commencement of a clinical trial

• The actual Clinical Trial Application (required field)

• As one of the required minimum criteria for the initial expedited reporting of SUSARs, the specification of the EudraCT number acts as the study protocol number

• The first page of an adverse event report

• On the label of the IMP (required)

• On the study protocol (required)

Advice - Hints and Tips

For specific information, review the up-to-date EudraCT User Manual and the FAQ guide:

• https://eudract.ema.europa.eu/docs/userGuides/EudraCT_Public_User_Manual.pdf(accessed November 2010)

• https://eudract.ema.europa.eu/docs/userGuides/EudraCT_Public_FAQ.pdf (accessed November 2010)

Operational Instructions

The process of obtaining a EudraCT Number includes the following 5 steps:

1. Visit the website of European Clinical Trials Database: https://eudract.emea.europa.eu/

2. Click the following button ‘Access to EudraCT Application’ on this page.

3. Next, a new page, ‘Welcome to EudraCT’ is shown.

4. Choose ‘Step 1’ for applying for a security code for a single clinical trial, which is valid only for 24 hours.

Next, you have to specify your name and e-mail address.

EudraCT Number Step 1

The first stage in the process is to obtain an authenticated security code. This security code will be sent to the e-mail address specified by you, the requestor, on the form, and is needed in order to complete the EudraCT Number request. The security code is valid for one EudraCT Number only and expires after 24 hours.

5. ‘Step 2’ in the process stands for the application of a EudraCT Number that will be sent to the given e-mail address and will never expire once it is issued.

On receipt of the security code, the following information is necessary for the preservation of the EudraCT Number:

• Name of the organisation of the applicant

• Address of the organisation of the applicant

• Name of the sponsor-investigator

• E-mail address of the sponsor-investigator for the dispatch of the EudraCT Number

EudraCT Number Step 2

This is the main EudraCT Number request that allows the requestor to obtain a EudraCT Number that will provide the unique reference for the Clinical Trial. The EudraCT number will be sent to the e-mail address specified by you, the requestor, on the form. ___

Important: The completed Clinical Trial Application Form must be stored before and during the study treatment process. It is recommended to store the XML file on an external medium for long-term storage (e.g. CD-ROM).

Optional:

6. After receiving the number, it is possible to look up the details of the Clinical Trial Application Form.

Create New Clinical Trial Application

Once you have the EudraCT Number and wish to enter Clinical Trial Application details please use this link.

Finally, the Clinical Trial Application Form should be stored in XML- and PDF-format on a CD-ROM and must be submitted to the Competent Authorities.

Please note: In the version 7 of EudraCT shown, you must save the XML files and the PDF files of your Clinical Trial Application Form to your own computer. You are unable to save XML and PDF files to the EudraCT system. Only the Member States’ Competent Authorities are able to do this when you send them your XML file.