FDA Regulatory Control of the Drug Development Process and Investigator Responsibility in the Process
October 23, 2012 - san francisco CA US
online compliance panel
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. In the FDA form 1572, the Investigator signs an agreement that has 9 statements, 7 of which begi n with "I agree".