Log in
Register|
vivekanand ☆ India, 2013-10-19 09:15 (4630 d 16:42 ago) Posting: # 11707 Views: 2,660 |
|
|
Dear All What is the time period of Ethics committee reconstitution once the existing committee has completed 2-3 years from the date of formation. Is this mandatory to change/replace the existing members. Is their any reference documents regarding duration and time period for ethics committee functionality. Regards vivekanand |
|
riteshsrmc ☆ India, 2013-10-23 14:58 (4626 d 10:59 ago) @ vivekanand Posting: # 11733 Views: 1,988 |
|
|
Hi Vivek! Point 1 : If EC keep reconstitution time: Does it add value? Evaluate it? You will get your answer. Point 2. : If EC memeber is complying well with , I mean align with the procedure. You no need to change/ replace existing memeber.Neverthless What EC does Vivek if non-compliance (repeated serious non-compliance and require termination of individual) observed pertaining to individual? I mean EC should have, but EC need to describe in the operating procedure under which circumtances EC memeber can be replaced. Point 3. see this.. 2.4.2.3. Terms of Reference (Indian GCP). The IEC members should be made aware of their role and responsibilities as committee members. Any change in the regulatory requirements should be brought to their attention and they should be kept abreast of all national and international developments in this regard. The Terms of References should also include a statement on Terms of Appointment with reference to the duration of the term of membership, the policy for removal, replacement and resignation procedure etc. Each Committee should have its own operating procedures available with each member. Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Dr_Dan] |
Ing. Helmut Schütz