Compile the file
Mandatory
The following are mandatory for a valid application:
- Cover letter of the investigator
- European "application form"
- Protocol (+ summary)
- Investigator’s brochure/ summary of product characteristics
- Method of recruitment - Recruitment material
- Information and consent form, patient documents
- Suitability/competence of the principal investigator/promoter by means of CV
- Proof of “no fault” insurance
- GDPR questionnaire
- Simultaneous submission to the FAMHP:
Written declaration that the study has been simultaneously submitted to the EC and the FAMHP.
Optional
If relevant for your study, the following components are also submitted:
- Suitability of the facilities/agreement of the supporting services involved
- Contracts/ financial agreements.
E.g. Clinical Trial Agreement, Material/Data Transfer agreement, Confidentiality agreement, contract access KWS, etc. - Miscellaneous
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?
Pay the study
No payment is necessary for academic studies (sponsor is a university, hospital, scientific fund, EORTC, etc.).
Supplement/modify the study
Finalise the study
The sponsor reports the end of the trial to the 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 the EC Research.