ICH-GCPInternational Conference on Harmonisation-Good Clinical Practice (Food and Drug Administration guideline)
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The questionnaire consisted of twenty multiple-choice questions type on basic principles of Good Clinical Practice in clinical research methodology based on the 1990 European GCP guidelines particularly ICH-GCP (E6) Guideline.
Yet another example is that ICH-GCP contains practically no language on justice and fairness, whereas the Declaration of Helsinki, CIOMS, and TCPS2 do.
Similarly, ICH-GCP is mainly directed at those researchers and sponsors who might contemplate submission of trial data to regulatory authorities for product licensure.
ICH-GCP policies emerge from a setting in which sponsors have substantial resources, and significant financial incentives to portray their drugs in the most favourable light possible.
Alongside other international guidelines, the SAGCP is based on the ICH-GCP as well as DoH (2004) (Section 1.
However, this requirement is absent from the ICH-GCP.
The trial is an open-label Phase II ICH-GCP compliant trial involving 30 patients with anemia, across 6 trial centres in India.
For instance, more information on good clinical practice can be found in "Good Clinical Practices" (GCP) guideline, also known as the ICH-GCP Guideline, which Health Canada introduced into its framework as a "guidance document".
The ICH-GCP begins by enumerating some general principles, such as the primordial importance of respecting the rights and well-being of research subjects and the need for a careful weighing of risks and potential benefits of clinical trials.
The ACRE training courses which have been accredited by the Dubai Health Authority have admitted the first students for training in ICH-GCP.
Currently, there are more than 150 CROs in India, out of which 20 comply with ICH-GCP guidelines.
Also, there is an increased awareness regarding ICH-GCP (International Conference on Harmonisation-Good Clinical Practice) guidelines for conduct of clinical research.