UK as first country intending to have 100% of all clinical trials registered and their results reported in the public databse

16-09-2020 / / Legislation

UK’s Health Research Authority new initiative is to reach 100% of clinical trials registration, including CT results, into the public database. This is in order to offer transparency regarding clinical trials and facilitate information sharing among the researchers.

This strategy:

  • is based…

Report on clinical trials transparency in The Netherlands

27-08-2020 / / Legislation

TranspariMED and Health Action International (HAI) have recently reported that Dutch institutions that run clinical trials violate the European transparency rules but failing to report clinical trials results in the public registry.

Only 1 out of 23 universities/research institutes has adequately…

First EMA newsteller regarding the Clinical Trials Information System (CTIS)

14-07-2020 / / Legislation

EMA board has announced that the implementation of the Clinical Trials Information system (CTIS) would be December 2021. The CTIS is the portal for the Clinical Trials Regulation 536/2014. 

Recently, EMA has released the first newsletter on the topic which gives…

EMA has announced that the EU portal ‘Clinical Trials Information System’ is expected to go live in December 2021

18-06-2020 / / Legislation

Clinical Trials Information System (CTIS), initially published in May 2014, is expected to go live in December 2021. From that moment on, the EU Regulation on research with a medicinal product will apply as well. CTIS is built for the implementation…

CCMO updated "Recommendations for the conduct of clinical research at the time of restrictive measures due to the coronavirus"

29-05-2020 / / Legislation

On 26.05.2020 CCMO has updated their recommendations for the conduct of clinical research at the time of restrictive measures due to the coronavirus. The PDF document can be downloaded here.