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:
Reservation and Submission
For your research you must reserve a place in one of our meetings. You can contact the business office (by telephone/email) to determine a date for discussion in the meeting. Simultaneously you need to send us a synopsis. The research file must be submitted 3 weeks before the meeting, see our meeting schedule
After the MREC meeting, you will receive the memo with the findings from us in approximately 5 working days, after the meeting.
The METC looks forward to the resubmission including the adjustments based on the memo.
In the event of a positive decision, you will be notified via e-mail and we will proceed to prepare a Letter of Approval.
To submit, follow the steps below:
1. How do I submit?
We would like to receive the research file, including Cover letter, from you in one of the ways listed below:
- digitally via your own portal or medium of your choice
- by email in attachment(s): firstname.lastname@example.org
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.
2. What do I submit?
- Use of the BEBO template cover letter (mandatory).
MREC BEBO has implemented its own cover letter. We request that you use this letter.
- Your research file must meet the requirements of the CCMO (see web page ‘Standard research file’ on the CCMO website).
What should I pay attention to?
What requirements must the submitted documents meet?
- 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).
- Prepare the ICF according to the CCMO template (mandatory) and do not change paragraph 10.
- CVs: this should be a recent CV including date and BIG-registration.
- 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.