Local approval Executive Board Amsterdam UMC

  • WMO
  • Non-WMO

For all research subject to the WMO, CTR, MDR or IVDR conducted at Amsterdam UMC, local approval of the Executive Board is required before you can start your study.  

The local approval letter is issued after completing several local processes, including the site suitability assessment, financial arrangements and the medical ethical review process. It is based on three legal documents: 

Requesting local approval from the Executive Board is done via Research Manager (referred to as: Lokale Uitvoerbaarheid, LU). Instructions are available on the MREC Amsterdam UMC website, including a list of required documents and manuals for Research Manager. 
The exact steps vary depending on the type of research and the review committee involved (see table below). 

Research Review committee Local approval procedure (LU)
Subject to the WMO/MDR/IVDR MREC Amsterdam UMC MREC Amsterdam UMC initiates the LU-request in Research Manager. Researchers receive a notification and may need to provide additional information or documents.
Subject to the WMO/MDR/IVDR Other After the review committee approves Amsterdam UMC as a participating site, researchers submit a LU-request in Research Manager.
Subject to the CTR MREC Amsterdam UMC / Other After approval by the review committee (for Amsterdam UMC as a sponsor or participating site), researchers submit a LU-request in Research Manager.
Non-WMO Non-WMO Review Committee Amsterdam UMC The non-WMO statement issued by the Non-WMO Review Committee of Amsterdam UMC suffices as local approval.
Non-WMO Other After the review committee issues a non-WMO statement, researchers submit a non-WMO reviewed elsewhere (1) in Research Manager. Researchers must also request privacy advice (2).

(1) non-WMO reviewed elsewhere, (2) privacy advice