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vivekanand ☆ India, 2013-04-29 16:35 (4395 d 12:32 ago) Posting: # 10502 Views: 7,679 |
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Hello I like to share that if the BMI range in protocol was not follwed what shall be the impact. As per protocol certain range has given as BMI for the study. we do screening is general screening, on the the day of check-in we select the volunterrs based on medical screening record and protocol requirment. Couple of subjects were selected into the study where the BMI range is not as per protocol. What shall be the impact? Can we proceed by raising protocol deviation or by a Note to file for the study. Regards Vivekanand Edit: Category changed. [Helmut] |
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jag009 ★★★ NJ, 2013-04-29 17:17 (4395 d 11:50 ago) @ vivekanand Posting: # 10503 Views: 6,599 |
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Hi. Did you get sponsor's approval to allow those subjects to be enrolled into the study? I placed some studies in the past and have encountered this. The CRO would inform me, ask me to decide and sign a note to file. John |
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Ohlbe ★★★ France, 2013-04-29 18:45 (4395 d 10:22 ago) @ jag009 Posting: # 10505 Views: 6,670 |
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Dear John, ❝ Did you get sponsor's approval to allow those subjects to be enrolled into the study? I placed some studies in the past and have encountered this. The CRO would inform me, ask me to decide and sign a note to file. This would not be acceptable for studies for EU submission. See the Q&A published by EMA's GCP inspectors working group. The protocol is not just something between the sponsor and the investigator: it is also approved by the IEC / IRB, and depending on the local regulations, by the regulatory authorities. — Regards Ohlbe |
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Helmut ★★★   Vienna, Austria, 2013-04-29 17:20 (4395 d 11:48 ago) @ vivekanand Posting: # 10504 Views: 6,908 |
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Hi Vivekanand! ❝ Couple of subjects were selected into the study where the BMI range is not as per protocol. ❝ ❝ Can we proceed by raising protocol deviation or by a Note to file for the study. The former. See ICH E3 Section 10.2 Protocol Deviations All important deviations related to study inclusion or exclusion criteria, conduct of the trial, patient management or patient assessment should be described.
 I casts a damning light on your procedures not complying with the protocol. Expect in the worst case that an assessor wants you to perform the BE assessment excluding these subjects.— Dif-tor heh smusma 🖖🏼 Довге життя Україна! ![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png) Helmut Schütz ![[image]](https://static.bebac.at/img/CC by.png) The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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Dr_Dan ★★ Germany, 2013-04-29 18:54 (4395 d 10:14 ago) @ Helmut Posting: # 10506 Views: 6,564 |
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Hi Helmut You are thinking of a cross over design (within subject comparison), but what would you do in case of a parallel design study? Then it could make sense to perform the BE assessment excluding these subjects.... However, I agree that these deviations increase doubts on the CRO's procedures not complying with the protocol. They should be prepared for an inspection if this is a pivotal study to be submitted to regulatory authorities. Kind regards Dan — Kind regards and have a nice day Dr_Dan |
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Helmut ★★★ Vienna, Austria, 2013-04-29 19:26 (4395 d 09:41 ago) @ Dr_Dan Posting: # 10507 Views: 6,526 |
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Dear Dan! ❝ You are thinking of a cross over design (within subject comparison), but what would you do in case of a parallel design study? Then it could make sense to perform the BE assessment excluding these subjects.... You are perfectly right! — Dif-tor heh smusma 🖖🏼 Довге життя Україна! Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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sarada06884 ☆ India, 2013-04-30 14:34 (4394 d 14:33 ago) @ vivekanand Posting: # 10508 Views: 6,562 |
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Hello ❝ I like to share that if the BMI range in protocol was not follwed what shall be the impact. The impact should be evaluated by the investigator and this should be intimited to the ethics committee. Further this protocol deviation should be reported in the study report. In the worse scenario as suggested by Helmut the regulatory inspectors may reveiw the results of the stusy including these subjects and also excluding the subjects. So assesment in both ways may be needed. ❝ As per protocol certain range has given as BMI for the study. Yes every protocol has it's own set of guidelines and there is a reason as to why the protocol was framed keeping the specified BMI in veiw. If the BMI is too low the drug may have some possible adverse effects and if the BMI of the subjects is too high the drug may not be effective at the given dosage. ❝ we do screening is general screening, on the the day of check-in we select the volunterrs based on medical screening record and protocol requirment. whatever the selection procedure may be but the selected subject should meet the requirements of the protocol. ❝ Couple of subjects were selected into the study where the BMI range is not as per protocol. This should be intimated to the ethics committee and a protocol deviation be raised for the same. If necessary the sponsor should also be informed regarding the same. ❝ What shall be the impact? As already discussed the results of the study should be acessed by including the subjects as well as excluding the subjects. Or else a proper scientific Evaluation/ justification is required. ❝ Can we proceed by raising protocol deviation or by a Note to file for the study. Since this is a deviation to the protocol a protocol deviation should be filed for the same evaluating the impact. A note ot file may not suffice this case as a note to file is only to capture extra information regarding a study. Regards Srinivas Edit: Standard quotes restored. [Helmut] |
Ing. Helmut Schütz