New research

Registration and submission of new research that is subject to the WMO Act

You want to submit a new study for assessment by the MREC of the BEBO foundation.

What is the procedure?

The procedure consists of three steps:

Submission

You should submit the research file digitally 11 working days (2 weeks) prior to the meeting. After the documents have been submitted, we check whether the research file is complete based on the CCMO structure. You may receive pre-meeting questions from us in the week before the meeting. To ensure a quick assessment, we ask you to answer these questions before the meeting.

Review

You will receive our assessment within two to three working days of the MREC meeting. You will usually be informed of the requirements set by the MREC via e-mail within 2 working days for phase I and II research, and within 5 working days for Phase III research. You can then resubmit the adjusted research file.

Approval

In the event of a positive decision, you will be notified via e-mail and we will proceed to prepare a Letter of Approval.

If the specified timeline cannot be met, you will be contacted to agree on a new timeline. Will we always try to meet your needs.

What should I submit?

To submit, follow the three steps below:

1. Sign up

Contact our office by telephone to agree on a meeting date in which your file will be discussed. After agreeing on a date, please send us a synopsis of the study.

2. How do I submit?

Send the original signed cover letter to us by post. You can submit the research file to us:

  • digitally via your own portal or medium of your choice
  • by email in attachment(s): info@stbebo.nl
  • on USB by post

The files may be submitted together in one folder / zipfile, but please do not create subfolders. We do not accept secure (PDF) files, even if the password is stated separately.

We recommend choosing a secure method of data transfer. Sending documents in a secure manner is always your own responsibility.

3. What do I submit?

In October 2020 the BEBO introduced its own cover letter. We request that you use this letter. The accompanying overview with a description of the submitted documents must also meet our new requirements.

What should I pay attention to?

What requirements must the submitted documents meet?

Format

  • Please follow our template cover letter.
  • The file name should be in English.
  • The length of the file names should be as short as possible (use abbreviations).
  • Please state version numbers in the file name as well as the table.
  • The date format should be ddmmyy (for example 01Jan20) in file name and in the table.
  • Submit all documents separately (no bulk files).

Contentwise

  • Prepare the ICF according to the CCMO template (mandatory) and do not change paragraph 10.
  • CVs should not be older than 1 year, and should be dated and signed.
  • Do you want to submit a draft Clinical Trial Agreement? The signed version must be submitted before the start of the study. In the cover letter, you should state that the signed version does not deviate from the draft version with regard to “publication” and “termination” agreements.
  • The resubmission must also be accompanied by a cover letter (please also send us -only- the cover letter via post after having submitted the entire resubmission file digitally).

An overview of the conditions / requirements for research files is published here on our website!

MREC Assen