Bioequivalence and Bioavailability Forum

Source Document: certified copies [GxP / QC / QA]

posted by Ohlbe – France, 2009-03-20 11:48 (5954 d 07:17 ago) – Posting: # 3383
Views: 7,128

Dear Preet,

❝ we are getting courier copy or fax copy form outstation/other site❝

❝ (here for CRO wewill be treating this copy as a source document! isn't it).

Dear Preet,

The situation is a bit more complex here. I would still consider the original document to be the source document, to be archived by the other CRO. I would not require a signature from the other CRO on the copy you get or on the fax. However this time I would recommend you to archive your copy in your study documentation.

The easiest would be to get a list of sampling time deviations (or whatever information you need) from the first CRO, not just copies of the CRF pages

Regards
Ohlbe

Complete thread:

• Source Document: certified copies Preet 2009-03-19 08:22 
  • Source Document: certified copies Ohlbe 2009-03-19 13:43
    • Source Document: certified copies Preet 2009-03-20 06:41
      • Source Document: certified copiesOhlbe 2009-03-20 10:48
        • Source Document: certified copies Preet 2009-03-20 12:33
          • Source Document: certified copies Ohlbe 2009-03-20 15:43
            • Source Document: certified copies Preet 2009-03-21 05:06