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anky1212 ☆ India, 2013-05-30 16:21 (4779 d 08:41 ago) Posting: # 10685 Views: 3,162 |
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Dear All, I had carried out a cross over study for Health Canada regulatory. After completion of the study, I had reconciled remaining IPs and stored the same in storage cabinets after sponsor approval. After few months sponsor sent me another shipment of IPs of same batch/ lot and asked me to merge this samples with retention samples of previous study. This is all to carry out steady state study for Health canada regulatory. After few months, due to some reasons, study was not performed and IPs got expired. My question is what should i do with this IPs. 1. Return all IPs to sponsor. 2. Remain All the samples after seeking approval from sponsor to consider all IPs as a retention sample for previous study I will choose second option. Please reply. Regards, anky1212 |
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Dr_Dan ★★ Germany, 2013-05-31 13:25 (4778 d 11:37 ago) @ anky1212 Posting: # 10693 Views: 2,636 |
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Dear anky1212 If you merged the retention samples of the first study with the samples of the second shipment, how do you know which samples were sent first? If it is not possible to differentiate between both shipments you (or better the sponsor) have a problem since you can not exclude that the conditions before and during the first and second shipment were exactly the same. However, retention samples are sponsorś responsibility, so you need to request advice from the sponsor. Kind regards Dan — Kind regards and have a nice day Dr_Dan |
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anky1212 ☆ India, 2013-05-31 15:01 (4778 d 10:00 ago) @ Dr_Dan Posting: # 10695 Views: 2,609 |
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Dear Dr. Dan, Thanks for your reply. I had same question in my mind. Hence, at the time of combining both shipments, i had made two envelope. One indicating retention sample of previous study and another indicating separately sent shipment. Hence, I already asked sponsor for his approval to store both shipment in storage cabinet. Regards, anky1212 |
Ing. Helmut Schütz