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 In the new procedure, the current Research Declaration has been replaced by the Site Suitability Declaration (Verklaring Geschiktheid Onderzoeksinstelling, VGO).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 […]

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 […]