In our country,the procedure of approval for clinical trials
is in compliance with "drugs and cosmetics rules" .
Recently,government has notified rules for grant of compensation
in case of serious adverse events (SAEs) like death and injuries
on account of participation in clinical trial of drugs including
biologicals and medical devices.
Ethics Committee of the medical institute conducting the trial,
the sponsor of trial and its principal investigator
will have to report the injury or death within 24 hours and
submit their separate reports to the independent
expert committee set up by the DCGI to review the case.
is in compliance with "drugs and cosmetics rules" .
- what is the recent development regarding grant of compensation?
Recently,government has notified rules for grant of compensation
in case of serious adverse events (SAEs) like death and injuries
on account of participation in clinical trial of drugs including
biologicals and medical devices.
- what is the procedure to get compensation?
Ethics Committee of the medical institute conducting the trial,
the sponsor of trial and its principal investigator
will have to report the injury or death within 24 hours and
submit their separate reports to the independent
expert committee set up by the DCGI to review the case.
Comments
Post a Comment