Arulsingh Jayaraman

2006-04-06 14:54
(6618 d 00:45 ago)

Posting: # 83
Views: 9,566

 IEC [Regulatives / Guidelines]

If a study is approved by IEC and later found that the non-scientific member was not present, will a written approval from this non-scientific member and his consent to the discussions documented in the meeting minutes of that meeting will be considered as corrective action by an auditor
Kartikeyan V S

2006-04-06 15:18
(6618 d 00:21 ago)

@ Arulsingh Jayaraman
Posting: # 84
Views: 7,352


Ethics committe is combination of scientific and non-scientific members. This type of constitution is made in order to balance the scientific and non-scientific issues during the study approval.

if a study is approved without the non-scientific group then such approval is not valid.

Getting a post approval from non-scientific group is not advisable.

Vienna, Austria,
2006-05-08 21:41
(6585 d 17:58 ago)

@ Kartikeyan V S
Posting: # 118
Views: 7,434


Hi Kartikeyan,

are you talking to yourself? :surprised:

Helmut (Forum Moderator)
UA Flag
 Admin contact
23,029 posts in 4,834 threads, 1,644 registered users;
30 visitors (0 registered, 30 guests [including 6 identified bots]).
Forum time: 15:40 CEST (Europe/Vienna)

We must be careful not to confuse data with the abstractions
we use to analyze them.    William James

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