Bioequivalence and Bioavailability Forum • Responsibility of IEC

Responsibility of IEC [GxP / QC / QA]

posted by Helmut – Vienna, Austria, 2010-02-26 16:33 (5952 d 10:47 ago) – Posting: # 4827
Views: 7,633

Dear drmunkundz & Ohlbe,

❝ ❝ Also, make sure to have your IEC invited during any of the ICF presentation and let them document the same with a precise point that you gave a copy of the ICD to the volunteer.

❝

❝ Where did you see this to be required ?

Right! I'm a little bit concerned about the phrases "your IEC" and "let them document...".
"Your IEC" doesn't sound independent (well, to be honest it rings my alarm-bell). I can't imagine a situation where the IEC (or some members) visit the CRO and document ongoing activities there. That's not their job - but the job of the internal QAU and/or of the external monitor.

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz

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Complete thread:

Copy of informed consent to volunteer esreddy 2010-02-22 07:09
- Copy of informed consent to volunteer dixit 2010-02-22 07:55
- Copy of informed consent to volunteer Ohlbe 2010-02-22 09:51
- Copy of informed consent to volunteer raghu 2010-02-22 12:24
- Copy of informed consent to volunteer drmukundz 2010-02-26 02:13
  - Copy of informed consent to volunteer Ohlbe 2010-02-26 13:27
    - Responsibility of IECHelmut 2010-02-26 15:33