To simplify processes and maintain uniformity in project management on the part of the research section following ...
In view of mandatory requirements for conducting clinical trials including the ongoing trials, all investigators ...
In case of serious adverse events of death, the reports are examined by an independent expert committee ...
The Investigator has to report all serious and unexpected adverse events to the CDSCO, the Sponsor or his ...
All clinical trials should be monitored. A data safety monitoring board (DSMB) should be created at institution ...
In addition to obtaining written informed consent, audio-visual recording of the consent taking process is a must, ...
Simultaneously, the clinical trial protocol must be registered at the ICMR Clinical Trial Registry www.ctri.in . ...
It is mandatory to seek and obtain approval for any new clinical trial from the CDSCO (DCGI office). Proposal for ...
Guidelines for conducting ‘clinical trials’ relate to the following:
Obtaining permission to start a clinical ...