Responsibility of Investigators (updated as per Rule 122 DAB)

Responsibility of Investigators (updated as per Rule 122 DAB)

Investigator shall report SAEs to the DCG (I),Sponsor and Ethics Committee within 24 hr.

The report of SAE of death, after due analysis shall be forwarded within ten calendar days to:

• Chairman of the EC
• Chairman of the independent Expert Committee with a copy to DCG(I)
• Head of the Institution where the trial has beenconducted.

The report of SAE other than death, after due analysis shall be forwarded within ten calendar days to:

• Chairman of the EC
• DCG(I)
• Head of the Institution where the trial has been conducted

The Investigator shall provide information through informed consent process to the subject about

• Essential elements of the clinical trial as per Appendix-V
• Right to claim compensation in case of trial related injury or death.
• Right to contact the applicant for the purpose of making claims in the case of trial related injury or death.