Informed Consent form in Clinical Trial

  • Sunny Panwar
  • Hemant Pal
  • Amrish Chandra
DOI https://doi.org/10.22270/ijdra.v7i1.307

Abstract

Informed consent form is a vital requirement for research study on the human participant. It is the consent which is given by the subject before participate in clinical trial. Informed consent mainly came in existence after the Nuremberg trail and the other guideline line like Helsinki Declaration and Belmont Report also play an important role in there evaluation. Informed consent form mainly contents the complete information about the clinical trial, protocol, duration, potential risk and benefit of the trial. Informed consent is revised from time to time, as the new information is available. In some case waiver of consent done by proper review by Institutional Ethic Committees (IEC).

Keywords: Informed consent, GCP, IEC, Schedule Y

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References

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How to Cite
Panwar, S., H. Pal, and A. Chandra. “Informed Consent Form in Clinical Trial”. International Journal of Drug Regulatory Affairs, Vol. 7, no. 1, Mar. 2019, pp. 41-46, doi:10.22270/ijdra.v7i1.307.
Issue
Vol 7 No 1 (2019): VOLUME 7, ISSUE 1, 2019
Section
Review
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