How does the submission under the ECTR work at the BEBO after January 31, 2022?
As of January 31, 2022, it is not mandatory to submit your research under the ECTR, however, you have the choice to do so.
- 1st year (2022): initial application according to old (Directive 2001/20/EC) and new legislation (CTR EU no 536/2014) is allowed
- 2nd (2023) and 3rd year (2024): all initial applications according to Clinical Trial Regulation
- 4th year and later (2025): all ongoing clinical trials should comply with the requirements of the Clinical Trial Regulation
Up to and including 2024, substantial changes can be submitted according to old legislation. Clinical trials not authorised under the regime of the CTR and still ongoing (2025 and later) have to be ended in 2024 or should switch before the end of this period into the regime of the CRT via a substantial amendment.
If the duration of the clinical trial is expected to be more than two years at the date of the primary application in the first year of the transitional period (= 2022) it is strongly recommended to apply for an authorisation under the regime of the CTR.
- We would appreciate it if you register your research study to us in good time prior to the submission, as usual. We continue to use a study agenda and although it is not necessary via the ECTR, we prefer to register and reserve a slot at one of our meetings. This way we can guarantee you that your study will actually be assessed by us. We would like to receive a synopsis either with the registration or in the period between registration and submission.
- You submit your research file to the CCMO in CTIS. We will receive a notification once the dossier is uploaded via the CCMO.
- When submitting your research file in CTIS, you can specify the MREC of Foundation BEBO as your preferred MREC. If you have registered your study and it is on our agenda, we will automatically accept the submission. If your study is not on our agenda, we may have to decline the assessment if all the slots for a meeting are taken. If there is a slot free, we will consider the assessment of the study.
- In 2022, our familiar pre-meeting question round will be maintained.
- We will keep our timelines as much as possible, also under the ECTR.