Log in
Register|
suchit_bhavsar ★ India, 2015-03-23 08:37 (3320 d 04:27 ago) Posting: # 14587 Views: 3,414 |
|
|
Hello to all, Hope all are fine I am having a query regarding the version changed ICF approved by IEC. Due to some major changes (i.e time point, blood loss, compensation)ICF version has been revised (i.e version 01 from version 00) Version 00 was already approved by IEC earlier (with 7 members approval) now in version 01,is it require to approve by IEC with 7 members or minimum 3 members are enough ? Kindly give valuable inputs Thanks and regards, Suchit Bhavsar |
|
Dr_Dan ★★ Germany, 2015-03-23 10:12 (3320 d 02:53 ago) @ suchit_bhavsar Posting: # 14590 Views: 2,724 |
|
|
Dear Suchit Bhavsar Apart from national law and/or regulation you should consider ICH Topic E 6 (R1) Guideline for Good Clinical Practice (CPMP/ICH/135/95) 3.2 Composition, Functions and Operations 3.2.2 The IRB/IEC should perform its functions according to written operating procedures, should maintain written records of its activities and minutes of its meetings, and should comply with GCP and with the applicable regulatory requirement(s). If the written operating procedures require a 7 members approval for amendments you will need 7 members. If the written operating procedures require a minimum of 3 members approval for amendments 3 members are enough. If there are no written operating procedures covering this topic you have a Problem and the IRB/IEC does not work according to ICH-GCP. I hope this helps Kind regards Dr_Dan — Kind regards and have a nice day Dr_Dan |
|
Ohlbe ★★★ France, 2015-03-23 10:39 (3320 d 02:26 ago) @ Dr_Dan Posting: # 14595 Views: 2,718 |
|
|
Dear Suchit, ❝ If there are no written operating procedures covering this topic you have a Problem and the IRB/IEC does not work according to ICH-GCP.  In addition to what Dan already said, the following should also be covered in the IEC's SOPs according to ICH GCP: § 3.2.3: An IRB/IEC should make its decisions at announced meetings at which at least a quorum, as stipulated in its written operating procedures, is present. § 3.3.5 (on 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. — Regards Ohlbe |
|
krish85 ☆ India, 2015-03-23 10:35 (3320 d 02:30 ago) @ suchit_bhavsar Posting: # 14594 Views: 2,731 |
|
|
You have revised your ICF because your protocol has been revised which includes major changes. You are going to take APPROVAL from DCGI for version 02 of protocol and ICF. (Not only intimation). Hence you can consider this as fresh application. For for this, you have to follow your ethics requirement for fresh application. (i.e all members) |
Ing. Helmut Schütz