FAQ

Cover Letters

Does the BEBO Foundation use its own Cover Letters?

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.

 

Can I continue to use my own cover letters?

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.

 

For which submissions do I also need to send the cover letter by post?

For all submissions for which you receive an official statement or Letter of Approval from us (initial submission of a study and associated resubmission(s), substantial amendment including any resubmission(s), dose escalation reports and CSR).

 

What should I do if I forgot to send a document?

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.

 

Submission

How do I reserve a time slot for a meeting?

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

 

How, what and when should I submit for an initial submission?

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.

 

What can I expect before and after the MREC meeting?

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.

 

Ongoing Research

Do I also have to report foreign SAEs / SUSARs?

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

 

Should I also report SAEs / SUSARs that have occurred with the same IMP in other studies?

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).

 

Are there other ways to provide safety information, progress reports, final reports?

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.

 

Substantial Amendments

How do I know if an amendment is substantial or not?

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.

 

What does the review of a substantial amendment cost?

A review by the chairman costs €400, excluding VAT. If, in addition to the chairman, several MREC members participate, an assessment costs €800, excluding VAT. Only amendments that have a very high impact are discussed in a MREC meeting. In that case, an assessment costs  €2.700, excluding VAT.

 

Non-Substantial Amendments

Is it necessary to submit a B5 form for non-substantial amendments?

No, the B5 form is specifically for substantial amendments.

 

What are the costs of submitting a non-substantial amendment?

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

 

What happens if the MREC decides an amendment is substantial?

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.

 

Is it mandatory to submit non-substantial amendments to the MREC?

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.

 

MREC Assen