Rocky...IMO this is not a concern: Two , the di
Post# of 72444
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Posted On: 08/22/2021 10:52:36 AM
Re: rockyracoon #70169
Rocky...IMO this is not a concern:
It is my understanding the RAW results of the trials in Russia and the U.S. (blood samples, etc)...data is assembled and scrubbed at the CRO/Lab level outside Russia...like EU lab engaged by CRO, and that information off-site is entered by FDA approved Data Computer company, which enters the data and generates computer data for analysis...not a function of Clinical Trial site...
Trial sites take the raw information of the patient and forward it on to CRO/Lab controlled by CRO and pass on Data Entry and Analysis company (FDA Approved) chosen by CRO in consultation with the company. No need to fret...there is no "Russian computer system" involved...the Trials sites are delivery boys to U.S. CRO...that's it.
Quote:
Two , the differences between computer systems between Russian and English systems plus any differences in reporting forms and field comparisons may be an issue that requires reconciliation. For example, we know what data the FDA is requiring, how is that match out to the Russian systems? In all likelihood, the majority of these issues are worked out. But there’s always somebody that didn’t get the memo.
It is my understanding the RAW results of the trials in Russia and the U.S. (blood samples, etc)...data is assembled and scrubbed at the CRO/Lab level outside Russia...like EU lab engaged by CRO, and that information off-site is entered by FDA approved Data Computer company, which enters the data and generates computer data for analysis...not a function of Clinical Trial site...
Trial sites take the raw information of the patient and forward it on to CRO/Lab controlled by CRO and pass on Data Entry and Analysis company (FDA Approved) chosen by CRO in consultation with the company. No need to fret...there is no "Russian computer system" involved...the Trials sites are delivery boys to U.S. CRO...that's it.
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