UMCG Research Register: database freeze
From 7th till 14th of June 2022 the UMCG Research Register (UMCG RR, Utopia) is closed. During that time, the dossiers will be transferred to a new system (PaNaMa). This means in the UMCG RR / Utopia no new registrations can be added. The METc UMCG only accepts new submissions with an UMCG RR number. Are […]
Toolbox UMCG: update checklist with Site Suitability Form
In the UMCG research toolbox references are added regarding the use of the Site Suitability Form: “In case of research with a medicinal product it is obligatory to follow the VGO (Verklaring Geschiktheid Onderzoeksinstelling or Site Suitability Declaration) procedure https://english.ccmo.nl/investigators/standard-research-file/i-participating-centres/i2-research-declaration-or-site-suitability-declaration.VGO part A and B can be found through this link. For other WMO research it is […]
Submission stop for trials with medical device
The European Medical Device Regulation (MDR) comes into effect per 26 May 2021. As a consequence the rules for submission, review en performance of clinical trials with medical devices change. Trials with a medical device that have been approved by the METc UMCG before 26 May 2021 may continue according to current rules and regulation, […]
Modified procedure for submitting local feasibility declaration
From 1 December 2020, the procedure for submitting a declaration of local feasibility for medical research will be modified. In the new procedure, the current Research Declaration has been replaced by the Site Suitability Declaration (Verklaring Geschiktheid Onderzoeksinstelling, VGO). To switch from the current procedure to new procedure a transitional period from December 1, 2020 […]
Clinical Trial Regulation expected to apply from 31 January 2022
The European Medicines Agency (EMA) has announced that the EU portal ‘Clinical Trials Information System’ (CTIS) is expected to go live from 31st of January 2022. See the original news item on the website of the CCMO: link
Conditions for (re)starting clinical research in healthcare institutions and CRUs aligned
As of 25 August 2020, the conditions for (re)starting clinical research in clinical research units (CRUs) are the same as those for healthcare institutions. This has been decided by the Health Care and Youth Inspectorate (IGJ) together with CCMO. See the original news item on the website of the CCMO: link
CCMO will be the competent authority for clinical investigations with medical devices
Starting 1 October 2020, CCMO will be the competent authority for clinical investigations with medical devices. This means that from then on, CCMO will take over the tasks of the Health and Youth Care Inspectorate (IGJ) for processing the notification of these investigations. See the original item on the website of the CCMO: link
New template Subject Information Sheet is mandatory from November 2020.
The CCMO has published a new template Subject Information Sheet for research subjects of 16 years and older (adults). Researchers are encouraged to use this new template. The template will be used as criterion for the review of the submitted written information for participants. This means that both the structure of the information as well […]