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