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For UMC Utrecht investigators

For UMC Utrecht investigators

At UMC Utrecht, all medical research in which human subjects are involved must be submitted to the MREC.

Click here to read more about our institutional policy.

Two routes uitklapper, klik om te openen

  • The research undoubtedly falls under the scope of the WMO: Submit the WMO file to the MREC
  • Medical scientific research that involves human subjects but that probably does not fall under the scope of the WMO, or where there are doubts as to whether the WMO is applicable: Submit the WMO / Non-WMO Form – see the page ‘Is review required?’ for more information and the form. 

You should only submit applications after a quality check by the Quality Coordinator of your division. Always contact your Quality Coordinator. For contact details, click here.

This page offers investigators of UMC Utrecht guidance and useful tips relating to the institutional requirements of UMC Utrecht. Here you will find links to relevant pages of other departments of UMC Utrecht.

Research Quality Coordinator

The Research Quality Coordinator of the division is the first point of contact for investigators who have questions about the relevant policy on medical scientific research at UMC Utrecht, Good Clinical Practice, legislation, and the design and execution of studies.

Online Research Support

Information on research, from research ideas to study conclusion. A distinction has been made here between WMO research (sponsor / participating centre), non-WMO research, Biobank research, DEC (Animal Ethics Committee), and fundamental research.

UMC-wide research procedures for research involving human subjects uitklapper, klik om te openen

As an investigator of UMC Utrecht, you can consult the page “UMC-wide research procedures for research involving human subjects” on Connect when looking for information on:

  • UMC-wide SOPs and policy (including policy documents)
  • Standard research forms
  • Quality assurance of research involving human subjects (NFU, risk classification, monitoring)
  • Auditing, tracers
  • The Clinical Drug Research Unit of UMC Utrecht’s pharmacy

The objective of these UMC-wide procedures is to realise uniformity in the steps to be taken to prepare for, execute and conclude research involving human subjects. UMC Utrecht wants to support investigators by offering guidance and advice to assure the quality of research involving human subjects. Several standard forms have been created as well.

You will also find information on a variety of topics like adverse event reporting, the EZIS User Manual for Research, and UMC Utrecht’s biobank policy.

Links

Only accessible via Connect (intranet)

Important points for attention uitklapper, klik om te openen

Research with a medicinal product

Research with medical devices

At UMC Utrecht you can contact the Medical Technology & Clinical Physics Cluster. 

For more information on sterile medical devices you can contact the sterile medical devices expert, Mr De Geus (jgeus2@umcutrecht.nl or DSMH@umcutrecht.nl).

UMC Utrecht investigators with questions about the Medical Technology & Clinical Physics Cluster or about medical devices in clinical research can send an e-mail to MTKF@umcutrecht.nl.

Guidance for document writing and study design (ethics, statistics, methodology, etc.)

Privacy and personal data

More information on personal data processing can be found on the intranet page “Privacy and information security”. Here you will also find the contact details of UMC Utrecht’s Data Protection Officer.

Research file and institutional documents uitklapper, klik om te openen

E1/E2. Template for Annex A to the DCRF subject information template

G1/G2. Subject and liability insurance

K3. Template for Clinical Trial Agreement

Biobank at UMC Utrecht uitklapper, klik om te openen

Sub-biobanks, release and use of bodily material

The rules for setting up biobanks and the use of bodily material for scientific research are set out in the UMC Utrecht Biobank Regulations. Both these activities must be reviewed in advance by the Biobanks Review Committee (TCBio).

Biobank and WMO file - combined file

In a study that is subject to the WMO and that is submitted to the MREC for review under said act, bodily material from patients of UMC Utrecht may be used, and this bodily material may be stored for future research that is still unknown. In this case, this biobank component of the file will be reviewed by the MREC at the request of the Biobanks Review Committee (TCBio) based on UMC Utrecht’s Biobank Regulations.

Link

UMC Utrecht as a local participating centre uitklapper, klik om te openen

Participation in research not reviewed by the MREC Utrecht

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

Research on gene therapy or a medicinal product with GMO

For research on gene therapy or a medicinal product with GMO that is being conducted at UMC Utrecht, a different procedure applies. Please consult the Research Quality Coordinator for more information.

In addition to the positive decision of the reviewing committee, please also include a copy of the permit granted when sending your request to the Executive Board.

More on research on gene therapy or a medicinal product with GMO

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

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