• Study medication rates and study medication Epic
    Study medication rates and study medication Epic As part of the harmonization of both pharmacy locations, the rates for the initiation/management of study medication by the pharmacy have been harmonized. The pharmacy also gives an update about the possibility to order study medication in Epic.
  • Dutch Trial Register (LTR) becomes Overview of Medical Research in the Netherlands (OMON)
    Dutch Trial Register (LTR) becomes Overview of Medical Research in the Netherlands (OMON) From 5 March 2024 on, the research data on onderzoekmetmensen.nl will be known as 'Overview of Medical Research in the Netherlands' (OMON). This means the use of the name Dutch Trial Register (LTR) has thus been dropped.
  • Transition trials: CTD to CTR
    Transition trials: CTD to CTR Trials authorised under the Clinical Trials Directive (CTD) need to be transitioned to the Clinical Trials Regulation (CTR), before Janauary 31, 2025. An expedited administrative procedure is foreseen for these so-called ‘transition trials’.

Archive

Transition trials: CTD to CTR
Template Investigational In Vitro Diagnostic Medical Device Dossier (IMDD-IVD) available
New update of the NFU Quality Assurance Guideline for research involving human subjects
Event: Mini symposium 'Ins and outs of MDR research'
Modification of study data in the Dutch Trial Register (LTR)
Handling the publication of trial documentation in K2 iProva
Harmonized approach to non-WMO review Amsterdam UMC
Patient participation in research from March 1st, 2023
Tipsheet medical device trials and the Medical Device Regulation (MDR).
Q&A Clinical Trials Regulation and CTIS
Merged MREC Amsterdam UMC as of January 1st 2023
New Dutch Trial Register online
From January 31, 2023, all new clinical trials application with medicinal products will be submitted through CTIS
Rates 2023: assessment of research under CTR, MDR and IVDR
Covid compensation arrangement for impacted young researcher
Amsterdam UMC Biobank Assessment Committee
JCI accreditation and research. How to be prepared?
Template research protocol for CTR studies available
New Subject Information Sheet template available
Dutch Trial Register (NTR) no longer available
Digitally sign study documentation
Digital Trial File (TMF/ISF) in Research Manager
New EU regulation for medicinal research (CTR) and the Clinical Trial Information System (CTIS)
Medical-ethical review of your research? Use Research Manager
Medical Device Regulation - Guidance map and Factsheet
Research & Waves, how to?