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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 ...
Advance directives were created in response to the increasing sophistication and prevalence of medical technology. [3] [4] Numerous studies have documented critical deficits in the medical care of the dying; it has been found to be unnecessarily prolonged, [5] painful, [6] expensive, [7] [8] and emotionally burdensome to both patients and their ...
An advance directive allows an individual to state what treatments he or she would want in a medical crisis, but it is not a medical order. [4] Advance directives are not portable in a sense that it is not accessible across medical systems, so it is the individual's responsibility to have the form on them at all times. [4]
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Expanded access or compassionate use is the use of an unapproved drug or medical device under special forms of investigational new drug applications (IND) or IDE application for devices, outside of a clinical trial, by people with serious or life-threatening conditions who do not meet the enrollment criteria for the clinical trial in progress.
Fortunately, your estate plan can let you bypass probate in Texas with these five common tools: Revocable Living Trusts. A revocable living trust is a legal entity you create to hold and manage ...
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 ...