Bioequivalence and Bioavailability Forum

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]