Bioequivalence and Bioavailability Forum

Dear Preet,

As Helmut often says: there can only be one...

I would consider the copy you make for your stats department as a working copy, not as a source document. I wouldn't be shocked if the copies were destroyed after use (if no note was taken on them at the stats department, which would then become source data), and only the original was kept in the study documentation. I wouldn't be shocked either if the stats department was provided with the original CRF pages, and returned them for archiving after use. This would also avoid possible problems with poorly legible copies. That's even why the ICH GCP guideline recommends that the original CRF be sent to the sponsor, and only a copy be kept by the investigator: in Phase II-III trials, data management is done by the sponsor, and it's easier to do it with the original CRF.

You don't need to have separate archives at each department of the CRO for the same study. It is much simpler to keep all essential documents of the study (as defined in ICH GCP, §8) centrally. There is no need then to have multiple copies of the same document.

Regards
Ohlbe