Registration with CTRI [Regulatives / Guidelines]

posted by drgunasakaran1  – 2021-06-02 13:39 (1498 d 13:36 ago) – Posting: # 22388
Views: 2,096

Dear Mr Suraj,

❝ Will Institutional Review Board approval and CTRI registration alone will be suffice to initiate the clinical trial.


Stem cell proposals should be reviewed and approved by the institutional committee for stem cell research (IC-SCR) before being submitted to the EC for consideration, in accordance with the National Guidelines for Stem Cell Research (2017).

Since Human Embryonic Stem Cells falls under the Category of Restricted Research, approval from National Apex Committee for Stem Cell Research and Therapy (NAC-SCRT) also required along with DCGI approval & CTRI Registration before initiation of clinical trials.

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:

UA Flag
Activity
 Admin contact
23,428 posts in 4,929 threads, 1,689 registered users;
56 visitors (0 registered, 56 guests [including 22 identified bots]).
Forum time: 03:16 CEST (Europe/Vienna)

To know that we know what we know,
and to know that we do not know what we do not know,
that is true knowledge.    Nicolaus Copernicus

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5