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
Review
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.
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.
Submission
To submit, follow the steps below:
1. How do I submit?
The research file, including submission letter, should be submitted via the CCMO’s Research Portal.
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?
Contentwise
- 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.
Tarifs