New Subject Information Sheet for adults now available
16-10-2020 | 14:27
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
01-10-2020 | 15:20
From 1 October 2020, CCMO will be the competent authority for clinical investigations involving medical devices. From that date, ...
Notifications of clinical investigations with medical devices to CCMO as of 1 October
11-09-2020 | 15:16
Starting 1 October 2020, CCMO will be the competent authority for clinical investigations with medical devices. This means that ...
From October 2020, CCMO will meet twice a month
11-09-2020 | 10:00
As of October 2020, CCMO will hold two meetings a month instead of one.
Immediate annulment of the human subject insurance statement
03-09-2020 | 15:46
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
25-08-2020 | 15:36
As of 25 August 2020, the conditions for (re)starting clinical research in clinical research units (CRUs) are the same as those ...
Brexit and clinical research
09-07-2020 | 12:16
The United Kingdom (UK) has left the European Union (EU) on 31 January 2020. A transitional period is now in place until 31 ...
Conditions for (re)starting clinical research
25-06-2020 | 17:19
The Health and Youth Care Inspectorate (IGJ) has published a document with the conditions for the (re)start of clinical research ...
Clinical Trial Regulation expected to apply from December 2021
17-06-2020 | 09:34
The European Medicines Agency (EMA) has announced that the EU portal ‘Clinical Trials Information System’ (CTIS) is expected to ...
Recommendations for the conduct of clinical research at the time of restrictive measures due to the coronavirus
26-05-2020 | 13:24
Flowcharts deferred consent for medical research in emergency situations
12-05-2020 | 16:27
CCMO has drawn up flowcharts to clarify when and if medical research involving subjects is allowed to take place in emergency ...
MDR postponed by one year to 26 May 2021
24-04-2020 | 13:31
The moment of ratification of the European Medical Device Regulation (EU no 2017/745 (MDR)) has been postponed by one year due to ...
European Commission agrees to postpone MDR by one year
03-04-2020 | 17:35
Due to the corona crisis, the European Commission has accepted the proposal to postpone the commencing date of the European ...
Emergency regulation for authorisation of research into COVID-19-targeted gene therapy or medicinal product containing GMO
03-04-2020 | 15:44
Due to the exceptional circumstances, the Ministry of Infrastructure and Water Management (IenW) has decided to accelerate the ...
Accelerated procedure (fast track) review of coronavirus research files
27-03-2020 | 16:39
UPDATE 27 March 2020: Procedure fast-track review by CCMO as review committee. Given the current developments around the outbreak ...
Fast track procedures MRECs
26-03-2020 | 14:45
Along with CCMO, a number of accredited MRECs have also set up fast track procedures for the accelerated review of research files ...
European guidance for management clinical trials during corona crisis
20-03-2020 | 17:23
The European Commission, the European Medicines Agency (EMA) and national Head of Medicines Agencies (HMA) have published a ...
From Friday 20 March only digital submission
19-03-2020 | 15:54
Due to the Cabinet's restrictive measures and adapted accessibility of the CCMO, the following provisions will apply to all ...