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81 news items
Clinical Trial Regulation expected to apply from January 31, 2022
The European Medicines Agency (EMA) has announced a new expected go-live date of the Clinical Trials Information System (CTIS): ...
Risk inventory important for conduct of clinical research
Yesterday, the cabinet declared a lockdown to reduce the spread of the coronavirus. In response to this, CCMO would like to draw ...
New version Investigational Medical Device Dossier (IMDD) template available
A new version of the Investigational Medical Device Dossier (IMDD) template is available. This version is an update of the ...
From 1 December 2020 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 ...
Guidance for MRECs on medical device investigations
As of 26 May 2021, the EU Medical Device Regulation (MDR) will be applicable. A new guidance sets out the implications for the ...
New Subject Information Sheet for adults now available
A new template for the Subject Information Sheet (SIS) for subjects aged 16 and over (adults) is now available on the CCMO ...
Register medical devices investigations with CCMO? Online tool offers a solution
From 1 October 2020, CCMO will be the competent authority for clinical investigations involving medical devices. From that date, ...
From October 2020, CCMO will meet twice a month
As of October 2020, CCMO will hold two meetings a month instead of one.
Immediate annulment of the human subject insurance statement
CCMO has decreed that the submission of a human subject insurance statement to the review committee in the case of a research ...
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 ...