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-objection statement’ for substantial amendments by way of an automatically generated e-mail. Amendments must be settled by the competent auhority within 35 days.
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
- All submissions should be sent to email@example.com
- Please mention the NL-number (see ABR form) for every submission.
- All documents should be submitted in pdf-format.
- Please consult the list Standard research file Explanation | Publication | The Central Committee on Research Involving Human Subjects (ccmo.nl) for the correct codes and examples of document titles
- Please state in the subjectline of the e-mail the NL-number of your study in ToetsingOnline, followed by a short description of the submission, for example: 'Submission L1. SUSAR research file NL12345.001.13'. Incorrect submissions are returned by the competent authority without processing. The competent authority does not send a confirmation of receipt. Do you have any questions? Please mail to firstname.lastname@example.org.
- You may send the following documents to email@example.com (preferably by Eudralink) to the competent authority:
- Substantive amendments
- SUSAR reports
- Annual safety update reports
- Study completion notifications and final reports
- It is not allowed to submit password-protected (pdf) files, even if the password is provided separately.
- Annual safety reports may also be submitted in ToetsingOnline.
Please note: E-mails containing references to Eudralink will only be accepted if both the link and the documents are not password-protected. The documents in Eudralink must be made available for a minimum of three months.
The email addresses of the competent authorities are: