Bioequivalence and Bioavailability Forum • Expedited Review from IEC in case of change in study design

Expedited Review from IEC in case of change in study design [Regulatives / Guidelines]

posted by amatewadi – Pune, 2012-01-11 06:31 (5269 d 10:52 ago) – Posting: # 7895
Views: 3,463
(edited on 2012-01-11 10:38)

Dear Ohlbe,

I want to confirm that for each new trial;
Is it required to take full IEC review? irrespective of the changes?

Edit: Full quote removed. Please delete anything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Ohlbe]

Complete thread:

Expedited Review from IEC in case of change in study design amatewadi 2012-01-09 12:46 [Regulatives / Guidelines]
- Expedited Review from IEC in case of change in study design Ohlbe 2012-01-09 15:54
  - Expedited Review from IEC in case of change in study designamatewadi 2012-01-11 05:31
    - New trial = new opinion Ohlbe 2012-01-11 10:40
- Sample size: parallel ≠ 2× cross-over! Helmut 2012-01-09 16:22
- Expedited Review from IEC in case of change in study design drgunasakaran1 2012-01-13 17:51
  - Expedited Review from IEC in case of change in study design amatewadi 2012-01-22 14:26