Registration with CTRI [Regulatives / Guidelines]

posted by drgunasakaran1  – 2021-06-02 11:39 (395 d 04:22 ago) – Posting: # 22388
Views: 673

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 S Gunasakaran MBBS MD
Disclaimer: The replies/posts are my personal opinions and it does not represent my company views on the same.

Complete thread:

UA Flag
Activity
 Admin contact
22,181 posts in 4,647 threads, 1,572 registered users;
online 3 (0 registered, 3 guests [including 2 identified bots]).
Forum time: Saturday 16:01 CEST (Europe/Vienna)

Reach for the stars,
even if you have to stand on a cactus.    Susan Longacre

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