Sentence examples for trial regulations from inspiring English sources
MADRID A Spanish HIV/AIDS researcher is facing a hefty fine for violating clinical trial regulations.
New clinical trial regulations now being drafted by Parliament will tighten procedures governing trials, he says.
TOPS is widely used and effective, and helps research units to comply with UK clinical trial regulations.
Quality control will be maintained through adherence to the study protocols, standard operating procedures, research governance and clinical trial regulations.
19 20 Under the Clinical Trial Regulations 2004, a minor, for CTIMP purposes, is anyone under the age of 16 years.
The directive attempted to harmonize trial regulations by raising the bar throughout, so that all trials now had the same requirements as multicenter transnational phase 3 trials.
And MEPs of the Public Health Committee in Brussels have approved new clinical trial regulation which, among other measures, will require testing to be officially registered, and for a summary of results to be presented in a publically accessible EU database.
Within this new clinical trial regulation, there are three relevant points regarding the preparation of radiopharmaceuticals for clinical trials: 1) Authorisation is no longer needed for the manufacture of diagnostic investigational radiopharmaceuticals for use in hospitals taking part in the same clinical trial based in the same EU member state.
In Canada, according to interviewees, the drug control agency (Health Canada) played only a modest role in drug trial regulation.
The policy stipulates that the EMA database, including clinical trial reports submitted for marketing authorization of medicines as of January 2015, will be made available to the public in line with the new EU Clinical Trial Regulation No 536/2014.
EURAMOS-1 was notable for addressing randomised questions in a rare cancer on an unprecedented scale and for launching at a time of profound change to European legislation related to trial regulation and governance [ 6].
