Temporarily amended procedures
Due to the coronavirus outbreak, the Research Review Department has amended its procedures. Please check this page regularly for updates.
Amended procedures uitklapper, klik om te openen
Availability of the secretariat
In connection with the measures taken to prevent the novel coronavirus from spreading, employees of the secretariat are mainly working from home at the moment. This means that there is currently no ‘open office hour’. As of 31 August 2020 you can contact us again by telephone Monday to Thursday from 1 to 4 p.m. You can also contact the secretariatvia e-mail. If you wish to consult with us, then please describe your question in your e-mail, and provide the telephone number on which we can contact you. We will answer your question as soon as possible, either by phone or via e-mail.
Research files have to be submitted entirely digitally for the time being. Please refer to the page How to submit for instructions on how to submit your file digitally.
The requirement to provide a cover letter with a wet signature for primary submission and substantial amendments has been suspended. Instead, a digital or scanned signature of the applicant will suffice. This also applies to appeals and objections.
Fast-track procedure for review of COVID-19 research files
If you wish to submit a file for COVID-19 research subject and if in your opinion fast-track review is necessary, please inform us of this beforehand (if possible several days in advance) and substantiate the need for a fast-track review procedure. Please also indicate what kind of study it concerns (e.g. research with a medicinal product or another type of research, which phase, interventional/observational, etc.). The subject line should read ‘urgent request / file concerning COVID-19’. The committee will then assess whether fast-track planning is necessary and feasible. For fast-track review by the competent authority, you can send an e-mail to email@example.com or firstname.lastname@example.org ‘FAST TRACK COVID-19’.
Submitters of non-registered COVID vaccine studies and multinational studies using drugs for the treatment of COVID who submitted it via CTIS, should contact the CCMO at email@example.com to discuss options for accelerated review (fast-track procedure).
Notification of temporary suspension of research
Please use the Template (Dutch only) for notification of study suspension for this. On the CCMO website you can read when this is applicable. For UMC Utrecht investigators, amended rules apply; you will find more information about this on Connect.
Instructions uitklapper, klik om te openen
Please also check the websites of the CCMO and the Dutch Health and Youth Care Inspectorate (IGJ) for instructions
European guideline (EMA) uitklapper, klik om te openen
European guideline (EMA) for the performance of clinical research during the coronavirus crisis
For UMCU investigators uitklapper, klik om te openen
Signature of the Research Manager
Please ask the Quality Coordinator what the options are.
Information on Connect
Participating institutions: UMC Utrecht, Prinses Máxima Centrum for pediatric oncology and Antoni van Leeuwenhoek