• Newsletter Quality Assurance Research / CMC - May 2025
    Newsletter Quality Assurance Research / CMC - May 2025 In this newsletter: - Revision of the GCP guideline - After transition: completing the CTIS dossier - Serious Breaches - DocuSign is back online - CMC tips - Upcoming events
  • Update: Study Medication in Epic
    Update: Study Medication in Epic All new unit-dose studies starting after July 1, 2025 will be initiated in Epic; support is available if needed.
  • (Ont)regel het onderzoek symposium
    (Ont)regel het onderzoek symposium Save the date; an interactive symposium for academic researchers. Topics will include the role of METCs/CCMO in the review of medical-scientific research, the grey area of (non-)WMO research, and the new participant information letter.

Archive

(Ont)regel het onderzoek symposium
Newsletter MREC / Quality Assurance Research / CMC
Newsletter Kwaliteitsborging December 2024
Mijn studie is geautoriseerd in CTIS. Wat zijn nu belangrijke vereisten?
Is uw geneesmiddelenonderzoek al overgezet naar CTIS? Wacht niet te lang - doe het nu!
Development and launch of a new BROK® course by GCP central
Harmonized study medication rates and study medication Epic
Dutch Trial Register (LTR) becomes Overview of Medical Research in the Netherlands (OMON)
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