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UMC Utrecht as a local participating centre

UMC Utrecht as a local participating centre

Which steps need to be taken to add UMC Utrecht as a participating centre for a study which has already been reviewed by a different MREC?

Step-by-step plan: UMC Utrecht as a local participating centre uitklapper, klik om te openen

1. Research declarationIf UMC Utrecht is a local participating centre, the local investigator must request a research declaration via the head of department.

    • The investigator must send this research declaration to the central principal investigator, together with the documents to be used locally, for review by the reviewing committee.
    • The reviewing committee’s decision on participation of UMC Utrecht will be sent to the principal investigator, who will inform the local investigator at UMC Utrecht about this by forwarding a copy of the decision.
    • The local investigator will ask the Executive Board of UMC Utrecht for permission for the performance of the study at UMC Utrecht via the MREC secretariat (see Step 2).
    • The Executive Board can subsequently give the local investigator permission for the performance of the study at UMC Utrecht, which is a precondition for the start of the study (see Step 2). 

For the exact procedure that applies in your division, please consult your division’s Research Quality Coordinator.

2. Permission from the Executive Board

A study cannot be started at UMC Utrecht without the Executive Board’s permission. After the reviewing MREC has issued a positive opinion on UMC Utrecht’s participation, the local investigator must ask the Executive Board for permission via the Permission Request Form.

The form can be submitted in PDF format as an attachment to an e-mail sent to the MREC secretariat.

For the exact procedure that applies in your division, please consult your division’s Research Quality Coordinator.


3. After obtaining permission

The sponsor must submit amendments, SUSARs, SAEs and progress reports to the reviewing committee for review. UMC Utrecht’s MREC secretariat does not need to be notified of this.

If the MREC secretariat receives documents in this regard, it will file them without sending the sender a response. Please note that this does not constitute approval from the MREC Utrecht. We will assume that the reviewing committee has reviewed those amended documents.

Exception: If the amendment results in a change to the number of subjects to be covered by UMC Utrecht’s subject insurance, this must be reported to the MREC secretariat.

Please do inform the MREC Utrecht about the start date of your study (date of first inclusion) and later on about the end date (date of final subject’s final study procedure) here at UMC Utrecht, as well as about the total number of subjects included at UMC Utrecht.

Insurance certificate

If UMC Utrecht’s insurance applies, a certificate of UMC Utrecht’s subject insurance will be required for the review by the MREC. This certificate can be downloaded via the Connect intranet page of the Legal/Administrative Affairs Department (only accessible to UMC Utrecht employees).

Participating institutions: UMC Utrecht and Prinses Máxima Center for pediatric oncology

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