Vol. 5, Issue 6, Part B (2019)
A case study for time line advance serious adverse reaction and compensation
A case study for time line advance serious adverse reaction and compensation
Author(s)
Sarita Yadav, Dr. Albin Jose J and Shreya Kathale
Abstract
India is one of the top ten countries in 2015-2016 who enrolled 3,841 Clinical Trial Participants or 2.92 Per cent of total Participants and 34.3 Per cent of trial Participants are Woman. The trial sponsor is responsible for on-going safety evaluation, reporting to regulatory authority and paying compensation in case of any serious adverse event occurs in clinical trials. As per India regulatory, Ethics committee and regulatory body responsible for monitoring right and safety of trial participants. In these articles, carryout delayed process for composition and less benefit for subjects.
How to cite this article:
Sarita Yadav, Dr. Albin Jose J, Shreya Kathale. A case study for time line advance serious adverse reaction and compensation. Int J Appl Res 2019;5(6):109-111.