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 Ohlbe – France, 2012-01-09 16:54 (5268 d 11:43 ago) – Posting: # 7882
Views: 3,617

Dear Prashant,

❝ Can IEC give expedited approval for protocol in case "change in study design (crossover to parallel) on basis of previously approved and conducted study with increasing the sample size two times" ?

The only reference to expedited approval in ICH GCP is in § 3.3.5 on IRB/IEC SOPs:
Providing, according to the applicable regulatory requirements, expedited review and approval/favourable opinion of minor change(s) in ongoing trials that have the approval/favourable opinion of the IRB/IEC.

I would not consider a switch from cross-over to parallel and doubling the sampling size to be a "minor change"... And if it is for a new, unapproved trial, based on a previously conducted study, it won't be considered as an "ongoing trial" either.

Regards
Ohlbe

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Regards
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 designOhlbe 2012-01-09 15:54
  - Expedited Review from IEC in case of change in study design amatewadi 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