IMP studies transferred to CTIS
Almost all IMP studies have now been transferred to CTIS. For news, updates and tips for after the transition, we refer you to the CTIS news items. For questions:
New head of Clinical Trial Pharmacy
As of November 2024 M.A.A. van der Veer will be head of the Clinical Trial Pharmacy (Kenniscentrum Geneesmiddelen Onderzoek – KGO) and will act as the responsible pharmacist. Delegation logs for ongoing studies will be updated gradually.
Quality Agreement for ISSs between manufacturer and pharmacy
For investigator-initiated studies where Amsterdam UMC acts as the sponsor, the institution is responsible for ensuring the quality of the investigational medicinal product (IMP). To maintain this quality, a quality agreement is established between the hospital pharmacy and the company responsible for producing the IMP. A quality agreement is created using a standard format tailored to the specific handling the company will provide. It is crucial to involve the hospital pharmacy at an early stage, especially for investigator-initiated studies, as establishing a quality agreement can sometimes be a time-consuming process. For questions:
trial.apotheek@amsterdamumc.nl
New policy WMO-proefpersonenverzekering Amsterdam UMC
The Board of Directors has decided to harmonize the financing method for the ‘proefpersonenverzekering’ with the former VUmc method as from January 1st 2025. This means that the costs for the ‘proefpersonenverzekering’ of trials that are approved by the METC will be taken centrally.
More information: Nieuws van de Medisch Ethische Toetsingscommissie (amsterdamumc.org).
non-WMO research
Within the framework of the VWS program “Regeldruk in Onderzoek” VWS has asked Health-RI to facilitate the follow-up trajectory regarding “Het Toetsingskader nWMO onderzoek”. One tries to find a solution for the large variation in review procedures and criteria between institutions, which often lead to unclarity, delay and administrative burden, especially in multicenter research. The METC of/and Amsterdam UMC is actively involved and contributes to solving this issue. For the time being, the current procedure is maintained at Amsterdam UMC.
All non-WMO studies initiated by Amsterdam UMC, conducted in Amsterdam UMC or conducted by Amsterdam UMC researchers must be submitted to the Non-WMO Review Committee of the METC Amsterdam UMC.
More information on the website of the METC Amsterdam UMC: Niet-WMO - Medisch Ethische Toetsingscommissie (amsterdamumc.org).
eConsent Amsterdam UMC
Section 6 of the WMO contains a number of provisions that allow electronic consent if it is sufficiently reliable and confidential. This procedure must be described in the research protocol and is assessed by METC. For detailed information, see the reference document prepared for METCs by CCMO.
Most importantly, the eConsent should support the process of informed consent in a safe and transparent way, with respect for the rights and privacy of participants.
During 2024 an eConsent pilot was conducted within Amsterdam UMC via ‘MijnDossier’ in EPIC. The results of this pilot were positive and eConsent Via ‘MijnDossier’’ can be implemented within AmsterdamUMC. If you are interested in using eConsent for your research, you can make an EPIC notification to Eva Service Center Research.
A practical instruction for researchers to set up or amend the protocol for WMO studies according to this CCMO guideline and technical information on the use of e-consent in MijnDossier will be made available through K2.
Other (commercial) available tools, such as Castor EDC, Your Research etc. are not yet approved for use in WMO trials. This will be further investigated depending on, amongst other things, national developments on personal data protection.
evaservicecentrum@amsterdamumc.nl
Launch new eBROK course - September 2024
As of September 2024, the updated eBROK course is live! The new course, developed by GCP Central in cooperation with the Dutch Federation of University Medical Centers (NFU), offers a comprehensive training for clinical researchers. The basic course is supplemented by in-depth modules depending on the type of research: drug research, medical device research, WMO research and/or nWMO research. The course is designed for continuous learning, keeping you up-to-date on changes in clinical research throughout the year.
The certificate is valid for one year and can be renewed thereafter.
For whom? All researchers involved in WMO trials, such as department heads, principal investigators and sub- or co-investigators, should be BROK certified. Other interested parties can also register.
You can apply via NFU eBROK. PhD students at Amsterdam UMC can register through the Graduate School's SDB Learning Platform.
For questions: brok-coordinator@amsterdamumc.nl
Launch ‘Netwerk Mensgebonden Onderzoek’
The research network of several years ago has been revived under the name: 'Netwerk Mensgebonden Onderzoek’ (NMO). The purpose of NMO remains the same: it aims to connect research professionals more easily in order to promote the exchange of knowledge.
The network organizes regular meetings and presentations on current research and quality assurance topics. The first meeting on Oct. 24 was a success, with topics including quality assurance, the Research Roadmap, the CCMO's Research Portal, and the European CTIS portal.
Would you like to be part of this network? Sign up via the Teams app with the code loehk91.
National transition to new ‘Onderzoeksportaal CCMO’ - webinars -
On February 3, 2025, the CCMO will start using the new Research Portal to replace ToetsingOnline. All information about this transition is now available on the CCMO website: Transition to Research Portal.
Webinars presenting the Research Portal and explaining how to use and enter data will be held in December, January and February. Participation in the webinars is free of charge. You can register via this registration form.