Academic - monocentric

Compile the file

Mandatory

The following are mandatory for a valid application:

• Cover letter of the investigator
• Protocol (+ summary)
• Method of recruitment - Recruitment material
• Information and consent form, patient documents
• Suitability/competence of the principal investigator/promoter by means of CV
• GDPR questionnaire
• Proof of “no fault” insurance

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?

Start your application

Pay the study

No payment is necessary for academic studies (sponsor is a university, hospital, scientific fund, EORTC, etc.).

Supplement/modify the study

• Submit progress report to the EC Research
• Submit amendments to EC Research
• Serious adverse events and protocol violations
• Closing studies at EC Research

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.

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.