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It concluded disclosure requirements fell short of what is required and proposed more comprehensive data collections. [ 11 ] In The Netherlands the Transparantieregister Zorg was founded in 2013, that requires full disclosure of payments above 500 euro from pharmaceutical companies and manufacturers of medical devices to healthcare workers ...
50 Protection of human subjects in clinical trials; 54 Financial disclosure by clinical investigators [2] 56 Institutional review boards that oversee clinical trials; 58 Good laboratory practices (GLP) for nonclinical studies; The 100 series are regulations pertaining to food: 101, especially 101.9 — Nutrition facts label related
Form 6: A federal judge issued a preliminary injunction against new Florida law that would have required local officials to disclose personal finances
The DRKS is an open access, free of charge online register for clinical trials and is available both in English and German. DRKS is part of the WHO's ICTRP. The DRKS works with two partner registries in Germany, DeReG (German Registry for Somatic Gene-Transfer Trials) and Clinical Trial Registry of the University Medical Center Freiburg. [4]
A court order is an official proclamation by a judge (or panel of judges) that defines the legal relationships between the parties to a hearing, a trial, an appeal or other court proceedings. [2] Such ruling requires or authorizes the carrying out of certain steps by one or more parties to a case.
The United States Food and Drug Administration's Investigational New Drug (IND) program is the means by which a pharmaceutical company obtains permission to start human clinical trials and to ship an experimental drug across state lines (usually to clinical investigators) before a marketing application for the drug has been approved.
In a clinical trial involving human subjects, a set of content known as a trial master file (TMF) must be produced in accordance with applicable international and local regulations. TMFs are a collection of documents and other artifacts which "individually and collectively permit evaluation of the conduct of a trial and the quality of the data ...
The site is usually a hospital or a similar health care institution that has adequate infrastructure and staff to meet the requirements of the clinical trial protocol. The scope of an SMO's responsibility is limited to the site and hence the eponymous title. Some (but not all) of the responsibilities include: Contract