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jag009 ★★★ NJ, 2018-07-11 23:27 (2494 d 22:43 ago) Posting: # 19034 Views: 4,615 |
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Hi all, Sort of a strange question but what are considered as enrolled subjects? Should standby subjects, the ones who are present at dosing to replace the original "panel" subjects in case they are dropped/withdrew prior to dosing in period 1, be included in the enrolled subject demographic table? Note that these standby subjects will not be dosed (and leave the clinic) if all original subjects get dosed in period 1. A few CROs said the standbys should be included in the "enrolled subject demographic table" Thanks John |
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Ohlbe ★★★ France, 2018-07-12 02:07 (2494 d 20:03 ago) @ jag009 Posting: # 19035 Views: 3,785 |
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Hi John, ❝ A few CROs said the standbys should be included in the "enrolled subject demographic table" IMHO they should be listed on the inclusion log in the TMF, but I don't see the point in adding their data to the demographics table. They were not dosed and their data are not used in any way to assess BE. — Regards Ohlbe |
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jag009 ★★★ NJ, 2018-07-17 08:36 (2489 d 13:34 ago) @ Ohlbe Posting: # 19075 Views: 3,735 |
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Thanks Ohlbe ❝ IMHO they should be listed on the inclusion log in the TMF, but I don't see the point in adding their data to the demographics table. They were not dosed and their data are not used in any way to assess BE. That's my thinking as well. I asked the CRO and their reply was "That's how our clinic has been doing it"  John |
Ing. Helmut Schütz