During and after the research: notifications to the competent authority
You only need to notify the competent authority of the following:
- changes to the research file (substantial amendment)
- unexpected adverse reactions (SUSARs)
- Development Safety Update Report/annual safety report
- suspension, premature termination or end of study
- clinical trial report (clinical study report)
The competent authority does not send a confirmation of receipt. The competent authority issues a ‘No grounds for non-acceptance’ for substantial amendments by way of an automatically generated e-mail.
In case of changes to the research file (substantial amendment) you must submit to the competent authority a cover letter (A1) the EudraCT form notification of amendment (B5) and, if applicable, an updated EudraCT clinical trial application form (B3). You only have to submit this form when it has been updated. All other updated documents do not have to be submitted.
The following do not have to be reported to the competent authority during and after the research:
- the decision of the reviewing committee (accredited MREC or the CCMO)
- the starting date of your research
- non-substantial amendments
- SAE reports
- SUSARs that the sponsor reports directly in the EudraVigilance database
- periodic SUSAR line listings
- annual progress reports
- notes of the Data Safety Monitoring Board (DSMB)
How to submit
You must state the NL-number of your research on each separate submission (see the ABR form). Submissions made during and after the research must be sent digitally. Ensure all documents are in pdf format.
The correct coding and titles of your documents are important for efficient processing of your submission. Use the list Coding and examples of document titles for digital submission. State the NL-number (generated in ToetsingOnline) of your research in the subject field of the e-mail, followed by a short description of your submission, for example ‘Submission L1. SUSAR research file NL12345.001.13’ The competent authority will return incorrect submissions without processing them. Please note that the competent authority does not send an acknowledgement of receipt. Do you have any queries? Send these by email to firstname.lastname@example.org.
Substantial amendments, SUSAR reports, annual safety reports, a report of the termination of the study and the clinical study report should be submitted to the competent authority by e-mail (maximum 8 MB), via Eudralink or by cd-rom. It is not permitted to submit protected (pdf-) files, even if the password is provided. Annual safety reports can also be submitted via ToetsingOnline.
Note: It is not permitted to send larger files over several emails. In that case you must use a cd-rom or Eudralink. Emails containing references to Eudralink will only be accepted when both the link and the documents are not protected by a password. Eudralink submissions need to be available for at least three months.
The addresses of the competent authorities are:
CCMO as competent authority: email@example.com
Central Committee on Research Involving Human Subjects (CCMO)
F.a.o. the competent authority
P.O. Box 16302
2500 BH The Hague
The Ministry of Health, Welfare and Sport as competent authority: firstname.lastname@example.org
Ministry of Health, Welfare and Sport (VWS)
F.a.o. Competent Authority (CA)
c/o Medicines Evaluation Board (MEB)
P.O. Box 8275
3503 RG Utrecht