What’s New in the BIMO Manual? Inclusivity

One small but significant change in the BIMO Compliance Program Manual for Sponsors and CROs is the replacement of the possessive pronouns “his/her” with “their.”

For example,

Determine if the sponsor obtained financial disclosure information from each investigator before his/her participation in the clinical trial…

has been replaced with

Determine if the sponsor obtained financial disclosure information from each investigator before their participation in the clinical trial…

And

The investigator should immediately notify his/her supervisor…

is now

The ORA investigator should immediately report to their supervisor…

It’s nice to see the FDA on board with inclusive language.