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bserve ● 2006-04-12 10:45 (6581 d 15:45 ago) Posting: # 85 Views: 7,315 |
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a small query regarding dispensing. after receiving Ip's from sponsor, we are identifying retention samples and storing in original container. Then we proceed to dispense as per the randomization schedule. The IP's are placed in plastic pouch. the pouch is labelled and an additional copy of the label is placed along with the IP. This additional label is pasted on the subject CRF for linkage at time of dosing. After dosing these pouches are destroyed with appropriate documentation. Is this in violation of any regulations? |
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H_Rotter ★ Germany, 2006-04-12 17:40 (6581 d 08:50 ago) @ bserve Posting: # 86 Views: 5,785 |
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Hi bserve! I do not see any violation of regulations, as long as you have your SOP/documentation system for drug accountability up and running  I once come across one sponsor who wanted not only return of unused medications, but also of all empty blisters... All the best, Hermann |
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bserve ● 2006-04-13 10:22 (6580 d 16:08 ago) @ H_Rotter Posting: # 87 Views: 5,704 |
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Yes, unfortunately we are also dealing with such a sponsor who wants blisters and evrything else that comes into contact with IP's. None of the regulations deal with how to deal with ignorant and stubborn sponsors. |
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Sumanta Goswami ☆ India, 2006-08-29 17:43 (6442 d 08:46 ago) @ bserve Posting: # 242 Views: 5,747 |
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Dear bserve, ❝ Yes, unfortunately we are also dealing with such a sponsor who wants blisters and evrything else that comes into contact with IP's. None of the regulations deal with how to deal with ignorant and stubborn sponsors. There is a chance of reaction between medicine and its container,and subsequently subjects taking medicine may suffer from adverse event. In such cases regulatory bodies may ask for medicine container. So some sponcors and CRO prefer to preserve the medicine containers till audits / as specified in their SOP. In case CRO preserve medicine container for sponcer it can ask for extra money. In future you can tackle such issues easily as follows. I suppose in your SOP you have mentioned to destroy medicine container after study is over.Before conducting study ask your sponcers whether they need medicine container / pouches. If yes, mention the same thing in protocol and after study hand over the containers to sponcer. As protocol everwrites SOP there should be any problem. Regards, Sumanta. |
Ing. Helmut Schütz