Bioequivalence and Bioavailability Forum • individual icf video capturing and its importance

individual icf video capturing and its importance [Regulatives / Guidelines]

posted by drgunasakaran1 – 2012-01-01 18:49 (5290 d 21:39 ago) – Posting: # 7844
Views: 5,609

Dear Mr.Kaushik,

Recently, DCGI issue the following statement in the BE NOC letter for most of the submitted applications.

"You should ensure that, during informed consent process, information to the subjects is provided individually and not in a group."

We never encountered a statement that the ICF process need to be both audio and video captured. Even if DCGI insists to do audio and video recording, it will give additional protection to the CROs that the ICF process are given as per the GCP and ICMR guidelines.

—
Dr Gunasakaran Sambandan MD
Disclaimer: The replies/posts are my personal opinions, and they do not represent my company's views on the same. LinkedIn

Complete thread:

individual icf video capturing and its importance kaushik089 2011-12-31 07:43
- individual icf video capturing and its importancedrgunasakaran1 2012-01-01 17:49
  - individual icf video capturing and its importance kaushik089 2012-01-02 08:39
    - individual icf video capturing and its importance drgunasakaran1 2012-02-06 14:08
      - individual icf video capturing and its importance kaushik089 2012-02-10 16:08
        
        thank u for ur valuable info Helmut 2012-02-10 17:38
        individual icf video capturing and its importance drgunasakaran1 2012-02-11 05:46
        
        individual icf video capturing and its importance akinapally 2013-11-21 11:46
        
        CDSCO: Draft guidelines Ohlbe 2014-01-10 12:49
        
        CDSCO: Draft guidelines drgunasakaran1 2014-01-13 05:48