Bioequivalence and Bioavailability Forum

Dear Ratnakar,

❝ Reporting it as Medical event leads to the following queries:

❝ Should it be considered for analysis of events in study report e.g. 12.2.2 Display of AE and 12.2.3 Analysis of AE such other sections of 12.2?

It should reported seperately in the final report under the heading Medical event.

❝ Where to record the event and in what format?

You can prepare seperate format for medical event or name of the format should be AE/ME Form

❝ Should post study examination of the subject required to be performed?

Not required provided there shloud be statement in the protocol that "Subject dosed with atleast single dose of investigational product shold be consider for safety profile interpretation.

❝ Treatment can be given but should volunteer be paid full compensation?

No. Volunteer should be compensated accordingly to his extend of participation.

❝ Or simply mention it as an AE (provision to be made in the SOP) but relationship to the study drug can be “Not related”?

You have to prepare separate SOP "handling of medical event" and include all the possible ways to handle this situation.

Consider this case as ME only It will really make procedure very simple and easy to interpretate.


Regards,
Swapnil Kuche

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