With the increasing surveillance / auditing by the investigative wing of the FDA / OHRP it behooves Physician and dentist Investigators to become familiar and knowledgeable regarding their responsibilities. To 'think' you know the rules of Clinical Research is not enough these days.
When the PI signs the FDA form 1572 (for IND studies) or the "Statement of the Investigator (for IDE studies), she / he is signing a legally binding document committing themselves to follow all of the appropriate regulations.
When the PI signs the FDA form 1572 (for IND studies) or the "Statement of the Investigator (for IDE studies), she / he is signing a legally binding document committing themselves to follow all of the appropriate regulations.
