Submitting commercial - monocentric EudraCT study to EC Research

Compile the file

Mandatory

The following are mandatory for a valid application:

Optional

If relevant for your study, the following components are also submitted:

Prepare the file

Only one file per component can be uploaded.

Do you have several files per component? Group them in a compressed folder (zip-file).

Submit the study

When you start your application, you need to complete the whole process.

Do you have all the components?

Start your application

Pay the study

The contributions are legally laid down according to the Royal Decree of 15 July 2004. Indexed amounts are applicable from 01/01/2023.

Provide the following data to EC Research on submission of the study:

  • Invoicing address (preferably an address in Belgium)
  • Name of contact
  • PO number (Purchase Order), if applicable
  • VAT number

You will receive an invoice from the Financial department of UZ Leuven (with payment reference).

Payment is only possible upon receipt of an invoice of the Financial department.

Supplement/modify the study

Supplement the study

Finalise the study

The sponsor reports the end of the trial to EC research according to the provisions specified in Article 21 of the Act of 7 May 2004:

§ 1. The sponsor shall inform the competent ethics committee in case of a monocentric experiment and the ethics committee competent for the single opinion in case of a multicentric experiment about the end of the experiment and this within a period of 90 days after the end of the experiment. [..]

§ 2. The 90-day period shall be reduced to 15 days if the experiment has to be terminated prematurely. The notification must clearly specify the reasons for the premature termination.

The end of a study must be notified to the EC Research through submission of a cover letter. The following information needs to be described:

  • whether or not the research will be terminated prematurely (with specification of the reasons if premature).
  • when the inclusion of subjects is closed (at local level or in all participating centres), when the last visit of the last patient took place (at local level or in all participating centres), etc.
  • when concluding a study with an EudraCT number, an additional Annex III form (End of trial form) must be submitted.

Within one year after termination of the study, a Clinical Study Report (CSR) needs to be submitted to the EC with a summary of the results. The results also need to be published in the EU Clinical Trials Database (EUCTR) within one year after completion of the study. The report in the EUCTR can be used as the CSR for EC Research.

Last edit: 13 January 2023