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The Clinical Trials Directive (Officially Directive 2001/20/EC of 4 April 2001, of the European Parliament and of the Council on the approximation of the laws, regulations and administrative provisions of the Member States relating to implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use) is a European Union directive that aimed at ...
^1 Chapter 166 of the Texas Health & Safety Code ^2 Robert L. Fine, M.D.'s detailings of futile care statutes and processes from Baylor Health System ^3 White House Press Briefing 2005-03-21 ^4 As discussed in "Fine RL. Point: The Texas Advance Directives Act Effectively and Ethically Resolves Disputes About Medical Futility. Chest 2009 136(4 ...
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 Texas Supreme Court has constitutional responsibility for the efficient administration of the judicial system and possesses the authority to make rules of administration applicable to the courts [18] in addition to promulgation and amend rules governing procedure in trial and appellate courts, and rules of evidence. [19]
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]
Strict rules of evidence is a term sometimes used in and about Anglophone common law.The term is not always seen as belonging to technical legal terminology; legislation seldom if ever names a set of laws with the term "strict rules of evidence"; and the term's precise application varies from one legal context to another.
European Union: In the EU, Good Clinical Practice is backed and regulated by formal legislation contained in the Clinical Trial Regulation (Officially Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC). [3] A ...
One of the earliest models for ethical human experimentation, preceding the Nuremberg Code, was established in 1931. [4] In the Weimar Republic of 20th century pre-Nazi Germany, the entity known as Reichsgesundheitsamt [5] (translating roughly to National Health Service), under the Ministry of the Interior [6] formulated a list of 14 points detailing these ethical principles.