As per GSR 53(E) – 30-Jan-2013
1. Essential elements of
ICD have been amended to include statements that –
- in the event of injury to
the clinical trial subject, such subject shall be provided free medical
management as long as required
- in case of trial related
injury or death, sponsor or his representative (whosoever has obtained
permission for conduct of clinical trial) shall provide financial
compensation for the injury or death
Above highlighted sentence was criticized
and Indian regulatory updated as follow
in GSR 292(E) – 24-Apr- 2014
- in the event of injury to
the clinical trial subject, such subject shall be provided free medical management as long as required or till
such time it is established that the injury is not related to the clinical
trial, whichever is earlier
2. The Format of ICF
have been amended to include-
- address,
- qualification,
- occupation (Student/Self -employed/Service/House
wife/others),
- annual income of the subject
and
- name & address of his
nominee and his relation to the subject
3. At the end of ICF
following should be documented on ICF:
Copy of Patient Information Sheet and
Duly filled Informed Consent Form shall be handed over to the subject or
his/her attendant
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