Yes, from 1 December 2020, the BEBO Foundation will use its own cover letters for submitting initial studies, resubmissions, substantial amendments, non-substantial amendments and for other submissions. Please use these when submitting your documents. You can find the cover letters under ‘Ongoing Research’, or by clicking here.

No, from 1 December 2020 we request that you use our own cover letters. This will take some getting used to at first. There will be a transition period of 3 months. If you use your own cover letter during the transition period, we will draw your attention to this. From 1 March 2021 we will no longer accept other cover letters and you will have to send a new cover letter at our request, after which we will continue to process the submission.

You don’t need to send the cover letter by post anymore.

Accidentally forgot to put a document in the submission package? It happens to all of us. Check carefully whether the document is already on the cover letter or whether a new cover letter is required. You can still submit the missing document with cover letter to us. Please do this as soon as possible so that it can be included in the review.

To reserve a time slot for a meeting, contact our office well in advance.

The New research page provides information on how to submit an initial study to us. It also indicates what you must submit, and what requirements some research file documents must meet. If you have reserved a time slot for a meeting, you can see when you must submit the research file at the latest in the meeting schedule.

You will receive questions from our pre-advisers in the days prior to the meeting. We would like to receive your answers to these no later than 15:00 on the day of the meeting. This process can speed up the review. In the days after the meeting, you will receive a Letter with Findings from us. If you are unable to answer the questions of the pre-advisers prior to the meeting, they will be included in the Letter with Findings. Also see this page in which we visualized the entire process of the BEBO Foundation.

Yes, the MREC must receive all national and international reports of studies that have been reviewed by the MREC.

You should send SUSARs that have occurred in other studies with the same study drug within the legal deadlines of 7 or 15 days. This applies to SUSARs that may affect the safety of the subjects participating in research that has been reviewed by BEBO. All other SUSARs should be included in a semi-annual security report (SSLL).

If you use the BEBO portal, you can also submit the information this way. Please always send an email to us (info@stbebo.nl) to let us know that you have uploaded data.

In principle, the sponsor / researcher decides whether an amendment is substantial or not. A guideline that can help you with this is that a substantial change has consequences for:

1. the safety or integrity (both mentally and physically) of the participants
2. the scientific value of the research
3. the conduct and procedures of the investigation
4. the quality or safety of any product used during the study

Since these are only general criteria, you will find some common examples below:

Changes in study design and goals, addition of a study center, change of sponsor or its legal representative, change of Principal Investigator (PI), and change in expected adverse events that may affect the overall safety and benefits of the study.

For subjects, everything that affects their safety and rights is substantial. This also includes, for example, the extent to which they are burdened. In addition, they have the right to be adequately informed. For this reason, you must always submit recruitment material to us for review, for example.

For our rates, please refer to this page.

No, the B5 form is specifically for substantial amendments.

There are no costs associated with submitting a non-substantial amendment.

We will then ask you to submit the amendment as a substantial amendment. This means that, in addition to the previously submitted documents, you must submit a new cover letter and a B5 form.

Strictly speaking, it is not mandatory to submit a non-substantial amendment. Nevertheless, our MREC would appreciate receiving any changes. This is also common practice. We value a complete and up-to-date research file.