Search results
Results from the WOW.Com Content Network
Clinical trials in India refers to clinical research in India in which researchers test drugs and other treatments on research participants. NDCTR 2019 and section 3.7.1 to 3.7.3 of ICMR guidelines [ 1 ] requires that all researchers conducting a clinical trial must publicly document it in the Clinical Trials Registry - India .
This file is a copyrighted work of the Government of India, licensed under the Government Open Data License - India (GODL). Authorization Method & Scope Following the mandate of the National Data Sharing and Accessibility Policy (NDSAP) of the Government of India that applies to all shareable non-sensitive data available either in digital or analog forms but generated using public funds by ...
An electronic trial master file (eTMF) is a trial master file in electronic (digital content) format.It is a type of content management system for the pharmaceutical industry, providing a formalized means of organizing and storing documents, images, and other digital content for pharmaceutical clinical trials that may be required for compliance with government regulatory agencies.
The Indian Council of Medical Research (ICMR), the apex body in India for the formulation, coordination and promotion of biomedical research, is one of the oldest and largest medical research bodies in the world. The ICMR is funded by the Government of India through the Department of Health Research, Ministry of Health and Family Welfare.
A phase 3 clinical trial with 25,798 participants found that the vaccine is 64% (95% CI, 29 – 82%) effective against asymptomatic cases, 78% (65 – 86%) effective against symptomatic disease, 93% (57 – 100%) effective against severe disease, and 65% (33 – 83%) effective against the Delta variant.
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 ...
Get AOL Mail for FREE! Manage your email like never before with travel, photo & document views. Personalize your inbox with themes & tabs. You've Got Mail!
An IB is intended to provide the investigator with insights necessary for management of study conduct and study subjects throughout a clinical trial. An IB may introduce key aspects and safety measures of a clinical trial protocol, such as: Dose (of the study drug) Frequency of dosing interval; Methods of administration; Safety monitoring ...