CDSCO ON 31ST JULY 2015 HAS RELEASED GAZETTE NOTIFICATION.
IMPORTANT POINTS :
- Audio-Visual Recording of Informed Consent Process shall only bemandatory for cases where vulnerable population is involved & the trial is of New Chemical Entity or New Molecular Entity.
- And it shall contain procedure of providing information to the subject and his understanding on such a consent.
- It shall be maintained by the investigator for record.
- For clinical trials of Anti-HIV and anti-Leprosy drugs, only audio recording of the informed consent process shall be mandatory.
- This rule is applicable from immediate effect.
Click here for Gazette copy of the same.