Analysis of the Compliance of Informed Consent Documents With Good Clinical Practice Guideline
Padhy, Biswa M
Gupta, Yogendra K
Contemporary clinical trials 2011 Sep; 32(5): 662-6
Informed consent document plays an integral part in the process of obtaining informed consent. Although India is fast gaining repute as a preferred clinical trial destination, only few studies have evaluated the compliance of informed consent documents with the Indian Good Clinical Practice guideline.
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Therapeutic Products Directorate Guidelines. ICH Harmonized Tripartite Guideline. Good Clinical Practice: Consolidated Guideline Unknown author (Health Canada. Therapeutic Products Directorate, 1997)