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To simplify processes and maintain uniformity in project management on the part of the research section following standard operating procedures are suggested for initiation of a clinical trial, ...

In view of mandatory requirements for conducting clinical trials including the ongoing trials, all investigators must apprise themselves of the existing rules and regulations related to clinical ...

In case of serious adverse events of death, the reports are examined by an independent expert committee constituted by DCGI to determine if the cause of death is due to following reasons, (which ...

The Investigator has to report all serious and unexpected adverse events to the CDSCO, the Sponsor or his representative whosoever had obtained permission from the CDSCO for conduct of the ...

All clinical trials should be monitored. A data safety monitoring board (DSMB) should be created at institution level to monitor adverse events occurring in a clinical trial. It is the ...

In addition to obtaining written informed consent, audio-visual recording of the consent taking process is a must, especially for the vulnerable population be done, confidentiality must be ...

Simultaneously, the clinical trial protocol must be registered at the ICMR Clinical Trial Registry www.ctri.in . It is mandatory to have CTRI registration for the trial to be granted operative ...

It is mandatory to seek and obtain approval for any new clinical trial from the CDSCO (DCGI office). Proposal for new clinical trial has to be submitted to the CDSCO, which is then reviewed by a ...

Guidelines for conducting ‘clinical trials’ relate to the following: Obtaining permission to start a clinical trial Registration of trial Obtaining consent of a trial participant ...