Bioequivalence and Bioavailability Forum

❝ I am not sure whether I understand your question.

❝ Are you asking whether the investigator should read (=review/assess) the record before signing it - or not?

Dear Jaime,

I am sorry for not clearly mentioning the question, but i think u r thinking in right direction. Let me elaborate the case.

The very first document is Medical Screening Record (MSR) of subjects which mentions all screening results including lab assessment, radiology assessment, ECG review, etc. This document is completed by the screening physician. Now, the principal investigator of the study declares the subject suitability for participation in the study based on these records obviosly after reviewing the same.

But, the exact question here is whether, to provide the evidence that the PI has reviewed this document prior declaring suitability of subject, PI's sign on this document (MSR) is required or PI's declaration regarding subjects suitability on saperate document itself is an evidence that the PI had reviewed screening results. To summarise, whether the PI should sign in the Medicals Screening Records as an evidence that the subect suitability was systematically given after proper review of screenign status or a mere statement by the PI suffice this purpose.

I hope the question is clear now.

Regards,

kapil.