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Virendra Patel ● 2007-03-22 06:23 (6628 d 17:50 ago) Posting: # 594 Views: 5,520 |
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Dear All Can anybody give me the reference or guidance on below mentioned issue: Our QA division is received the original IRB approved protocol from IRB member secretary and affix the QA original copy stamp on each page of the original IRB approved protocol. I have objection that nobody allow to tamper the original IRB approved protocol. Can you guys give me the suggestion whether m i right or wrong. Regards NK |
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Jaime_R ★★ Barcelona, 2007-03-22 15:35 (6628 d 08:38 ago) @ Virendra Patel Posting: # 595 Views: 4,627 |
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Dear Virendra! ❝ Can anybody give me the reference or guidance on below mentioned issue: Just my personal opinion. ❝ Our QA division is received the original IRB approved protocol from IRB ❝ member secretary and affix the QA original copy stamp on each page of the ❝ original IRB approved protocol. Why, to keep the QA personnel busy? The entire protocol must have been already reviewed and released by the QA before submission to the IRB. It's an uncommon procedure that the IRB sends the protocol back (normally they keep it). Anyhow, the receipt should be documented and only this (the receipt) should be checked by the QA. I don't see the point, why they stamp every page. ❝ I have objection that nobody allow to tamper the original IRB approved ❝ protocol. Full ACK! — Regards, Jaime |
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H_Rotter ★ Germany, 2007-03-22 16:12 (6628 d 08:02 ago) @ Jaime_R Posting: # 596 Views: 4,656 |
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Hello Jaime! ❝ Why, to keep the QA personnel busy? Nice reading you again - tartly as ever  I would strongly support your point of view. There are three possible outcomes from the IRB:
#2 and #3 will call - if possible - for corrective measures. Stamping pages is just fiddling about and a waste of time (assuring what?). Regards, Hermann |
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Ohlbe ★★★ France, 2007-03-26 15:57 (6624 d 09:16 ago) @ H_Rotter Posting: # 599 Views: 4,648 |
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Dear all, Well, if the IRB/IEC wants to send a stamped original back, why not. At least it is possible to check which version of the protocol was submitted for approval, which unfortunately is not always clear from the approval letter itself. But then, why should it go to QA and not straight into the Trial Master File, with the IEC/IRB documentation ? Now if they want to take a copy of it for QA's own records and loose their time stamping it with their nice stamp, that's their own business  .HS, I take the opportunity of this first post to thank and congratulate you for your web site and forum, which I have only come across recently. Regards Ohlbe |
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Helmut ★★★   Vienna, Austria, 2007-04-02 00:46 (6618 d 00:28 ago) @ Ohlbe Posting: # 611 Views: 4,622 |
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Dear Ohlbe! ❝ HS, I take the opportunity of this first post to thank and congratulate you for your web site and forum, which I have only come across recently. You are mostly welcome! I'm eager for your input, since our colleagues from France are notoriously underrepresented at international meetings and we all do need open discussions.  — Dif-tor heh smusma 🖖🏼 Довге життя Україна! ![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png) Helmut Schütz ![[image]](https://static.bebac.at/img/CC by.png) The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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Dr.Tarak Parikh ☆ India, 2007-04-05 11:51 (6614 d 13:22 ago) @ Virendra Patel Posting: # 631 Views: 4,601 |
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Dear virendra, In my opinion , once original protocol is been approved and IRB doesnt have any problems then there is no need to put stamp on each page of protocol by QA. only IRB stamp is require on each page then approved protocol should go to Trial master file.that reciept should be kept with QA. AS before sending to IRB protocol is reviewed by QA. I think ICF is the document which should be controled by QA and IRB both. you are right.. Regards Dr.Tarak Parikh MD |
Ing. Helmut Schütz