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Dr.Pravin ☆ Ahmedabad, 2009-02-12 11:25 (5545 d 10:00 ago) Posting: # 3227 Views: 5,722 |
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Dear HS, I just want to know that From which point of time we can consider protocol deviation. Case: One subject was enrolled in study, he was checked in and on the dosing he was consume water within pre dose water restriction time, he was discontinue from the trial based on protocol non complience, whether it should be consider as Protocol Deviation or not. — Dr.Pravin Ahir Co-Investigator, Accutest Research Pvt.Lab.(I), Ltd. Ahmedabad |
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Prashanth ☆ 2009-02-12 13:08 (5545 d 08:17 ago) @ Dr.Pravin Posting: # 3229 Views: 4,859 |
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Dear Pravin, as per the information available: based on the In house SOP title protocol deviation, the criticality should be mentioned in the SOP based upon the design and the process separately in the study. To the mentioned case, Are you speaking with respect to P1 or P2, type of study, type of drug, type of release of drug,A DME of the drug, amount of water consumed and what time before the predose. Does the protocol defines the protocol deviation to what extent? Based on the criticality withrespect to the process related error,it can be considered as protocol deviation and can be included in the study(Keeping the ethical issues with respect to the volunteer) on discussion with PK department and PI. If any clarification kinldy let me know. — Best Regards, Prashanth |
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Dr.Pravin ☆ Ahmedabad, 2009-02-12 13:54 (5545 d 07:31 ago) @ Prashanth Posting: # 3230 Views: 4,738 |
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Dear Prashant, thanks for reply, the case is for the prior to dosing of P1, if protocol specify that No water except the 240 ± 02 mL given with drug administration will be allowed from 01 hour before to 01 hour after dose administration. so what to do in such case, consider as protocol deviation or protocol non complience. — Dr.Pravin Ahir Co-Investigator, Accutest Research Pvt.Lab.(I), Ltd. Ahmedabad |
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babun14 ☆ 2009-03-05 13:42 (5524 d 07:43 ago) @ Prashanth Posting: # 3321 Views: 4,573 |
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Hi Prashant Based on your in house SOP the decision should be taken . In general, as non compliance is the reason for dropping out the subject and if there is any provision in your system for addressing non compliance, relevant form to be filled up. Protocol deviation generally be done when subject still allowed for the study and to assure the regulatory that deviation has not affected the outcome in a significant way. Again, it can vary for different organization. The main concern to be reporting of the non compliance. Other suggestion is welcome . Thanks Bani -- Edit: Full quote removed. Please see this post! [Ohlbe] |
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Prashanth ☆ 2009-03-05 14:15 (5524 d 07:10 ago) @ babun14 Posting: # 3322 Views: 4,708 |
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Hi Bani. In general there are two types of deviation, project specific deviation and SOP deviation. When both protocols and SOPs are available for a procedure, the protocol takes precedence over the SOPs and any deviation from the SOPs will not be recorded as an SOP deviation if the study is in accordance with the protocol. We need to specify the impact on quality of the deviation in the forms and CAPA can be applied for the deviation incoordination with the departmental heads. Still further clarifications, kindly let me know. Regards Prashanth |
Ing. Helmut Schütz