CTR: Submission to Foundation BEBO

For information about de CTR, see the CCMO website.

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 (till 31 January 2023): initial application according to old (Directive 2001/20/EC) and new legislation (CTR EU no 536/2014) is allowed
  • 2nd (till 31 January 2024) and 3rd year (till 31 January 2025): all initial applications according to Clinical Trial Regulation
  • 4th year and later (from 31 January 2025): all ongoing clinical trials should comply with the requirements of the Clinical Trial Regulation

Ongoing studies (CTD)
Up 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 CTR via a substantial amendment. 

Registration of new trials (CTR submissions)

We would appreciate it if you let us know in good time when you have selected the BEBO as the preferred MREC to assess your research.

National studies
For national studies it is still possible to reserve a slot for one of our meetings. You can do this by contacting the office (by telephone/mail). At the same time, you send us a synopsis and the CT number of the study. The study must be submitted via CTIS 3 weeks before the meeting, see our meeting schedule.

Multinational studies
Unfortunately, for multinational studies it is not possible to reserve a slot for one of our meetings due to assessment by various parties, the timelines cannot be planned by the BEBO Foundation in advance. We would appreciate it if you inform us of the trial. We would like to receive the CT number, the planned submission date and information about the type of study involved: RMS or MSC as soon as possible.

Ongoing trials (CTR submissions)

We would like to receive an e-mail when a (non)-substantial amendment is submitted in CTIS in order to be able to process it as quickly as possible.

Important

  • 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 should specify the MREC of Foundation BEBO as your preferred MREC in the Cover Letter.
  • We strongly advice you to submit part 1 and part 2 simultaneously for both national and multinational studies.

MREC Assen