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sparsh ☆ India, 2013-10-01 08:49 (4648 d 18:26 ago) Posting: # 11578 Views: 2,243 |
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I have planned a BE study, protocol and its appendices having version 01 now I want to bit changes in ICD (appendix), My question is that shall I have to change and version the ICD and make it 02 or is there need to version the protocol also. Regards, Sparsh |
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Dr_Dan ★★ Germany, 2013-10-02 12:35 (4647 d 14:40 ago) @ sparsh Posting: # 11589 Views: 1,773 |
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Dear Sparsh For future studies: You could avoid this problem if you do not attach the ICD as an appendix to the protocol. The ICD is a stand alone document which can be revised without preparing a new protocol version  . Please be advised that each new ICD version needs to be approved by the ethis committee. Therefore I would suggest to prepare a file note explaining (not only for the ethics committee but also for possible inspectors) that ICD version 02 refers to protocol version 01 and make sure that the ethics approval also contains this information.IMHO it would make no sense to prepare a version 02 of the protocol if there are no changes. Otherwise an amendment needs to be filed and this of course would justify a version 02. I hope this helps Kind regards Dan — Kind regards and have a nice day Dr_Dan |
Ing. Helmut Schütz