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anky1212 ☆ India, 2013-07-12 08:49 (4731 d 17:49 ago) Posting: # 10972 Views: 3,996 |
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Dear All, We had conducted one BABE study for USFDA regulatory. Sponsor had provided sufficient samples including retention samples. After sending of samples, sponsor had requested to return remaining IPs above retention sample quantity (Except returned unused IPs once study is completed. i.e. retention samples to be retained + returned unused dispensed IPs to be retained and remaining unused IPs to be return to sponsor. Kindly give your views for the same. As per guideline, is it possible to return the IPs to sponsor?? Thank you. |
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jag009 ★★★ NJ, 2013-07-14 23:04 (4729 d 03:33 ago) (edited on 2013-07-15 16:41) @ anky1212 Posting: # 10973 Views: 3,376 |
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❝ We had conducted one BABE study for USFDA regulatory. ❝ ❝ Sponsor had provided sufficient samples including retention samples. After sending of samples, sponsor had requested to return remaining IPs above retention sample quantity (Except returned unused IPs once study is completed. The sponsor intends to submit the study? If not then he can have them all back, I.e., failed study. I used to ask for products to be return later if the study fails. Why? The clinic charges us for sample disposal after a while. John |
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Ohlbe ★★★ France, 2013-07-15 13:44 (4728 d 12:54 ago) @ jag009 Posting: # 10974 Views: 3,282 |
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Dear John, What if for some obscure reason the sponsor sent the CRO more test article that would be needed to run the study + the retention samples. Would they be able to ask the CRO to send them back the excess test article, and just keep the amount needed as retention samples ? I don't see a reason why this wouldn't be accepted, as long as the sponsor do not select themselves which bottle has to be sent back and which should be kept as retention sample. — Regards Ohlbe |
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jag009 ★★★ NJ, 2013-07-15 18:14 (4728 d 08:24 ago) @ Ohlbe Posting: # 10978 Views: 3,267 |
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❝ What if for some obscure reason the sponsor sent the CRO more test article that would be needed to run the study + the retention samples. Would they be able to ask the CRO to send them back the excess test article, and just keep the amount needed as retention samples ? I don't see a reason why this wouldn't be accepted, as long as the sponsor do not select themselves which bottle has to be sent back and which should be kept as retention sample. Yes that should be fine as long as there are paper trails (memo) documenting the request and action. John |
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