Template research protocol for CTR studies available on CCMO website
21-07-2022 | 10:44
As of 21 July 2022, the template research protocol for studies falling under the CTR is available on the CCMO website.
New Subject Information Sheet (SIS) template now available on the CCMO website
15-07-2022 | 12:57
A new template (in Dutch) for the Subject Information Sheet (SIS) for subjects aged 16 and over (adults) is now available on ...
Dutch Trial Register (NTR) no longer available
24-06-2022 | 10:13
The Dutch Trial Register (NTR) is no longer available. The National Trial Register, in which the CCMO Register and the former NTR ...
MREC NedMec ready for review of research files
15-04-2022 | 12:24
As of 15 April 2022, MREC NedMec, the result of the merger of MREC AVL and MREC Utrecht on 1 January 2022, offers review of ...
Therapeutic vaccines now only reviewed by MRECs
08-04-2022 | 16:48
Based on the Central Review of Medical Research Involving Human Subjects Decree ( Besluit Centrale Beoordeling), the assesment ...
New online tool makes CTR scope more transparent
23-12-2021 | 17:12
The new Clinical Trial Decision Tool helps you to determine whether your study with a medicinal product falls within the scope of ...
CCMO kicks off programme on patient participation in clinical trials
23-12-2021 | 17:11
To promote patient participation in clinical trials, CCMO is launching a programme to cooperate actively with other parties. ...
New EMA document for sponsors on CTIS
10-12-2021 | 09:41
The European Medicines Agency (EMA) has published a new document on the Clinical Trials Information System (CTIS). The document ...
CCMO closed between Christmas and New Year’s Eve
01-12-2021 | 15:30
Due to the holiday season, CCMO will be closed from Monday 27 December 2021 to Monday 3 January 2021.
Information EU Clinical Trial Regulation available on CCMO's website
15-11-2021 | 15:47
On 31 January 2022, the EU Clinical Trial Regulation (CTR) 536/2014 will apply with new rules for research with medicinal ...
New directive makes use of Site Suitability Declaration (VGO) obligatory for research with a medicinal product as of 1 November 2021
18-10-2021 | 09:00
CCMO’s directive on the assessment of the suitability of research centres (TGO) has been adopted and will apply to studies with ...
Rates established for assessment of research under CTR and MDR
17-09-2021 | 11:13
The Ministry of Health, Welfare and Sport has set the rates for medical ethical review in the Netherlands of research under the ...
Clinical Trial Regulation (CTR) applicable from 31 January 2022, VHP concludes on 15 October 2021
04-08-2021 | 10:38
On 31 July, the European Commission has announced in the Official Journal of the European Union that the Clinical Trial ...
Site Suitability Declaration (VGO) as of 1 November 2021 obligatory for research with a medicinal product
09-07-2021 | 14:55
As of 1 November 2021, use of the Site Suitability Declaration [Verklaring Geschiktheid Onderzoeksinstelling, VGO] will become ...
Changes in CCMO's assessment task for specific types of research
29-06-2021 | 16:36
CCMO’s assessment task has been adapted for specific types of research. These adaptations have been laid down in the Dutch ...
Information EU Medical Device Regulation available on CCMO website
24-06-2021 | 17:06
On May 26, 2021, the EU Medical Device Regulation (EU no 2017/745, MDR) has come into effect. The MDR contains specific rules for ...
CCMO reviews research on cell therapy, gene therapy, other products that specifically influence the functioning of the genetic material and medicinal products with GMO
18-05-2021 | 11:21
CCMO’s website clarifies when CCMO is the designated review committee for certain types of research.
Clinical Trial Regulation to apply from January 31, 2022
22-04-2021 | 16:28
The European Medicines Agency (EMA) has confirmed that the development of the Clinical Trials Information System (CTIS) is on ...