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. This talk, by a certified physician investigator, will go over the regulations in a user friendly way. In the FDA form 1572, the Investigator signs an agreement that has 9 statements, 7 of which begin with “I agree”.
Protocol Deviations and Violations are one of the most common problems identified by FDA Investigators and is a main reason for the rejection of clinical data from a particular site or even a study. Forewarned is forearmed.
Enjoys making presentations and Webinars on a variety of GCP subjects such as Investigator Responsibility in Clinical Research, The Role of Adverse Event Determination and Reporting in Drug Safety, Data and Safety Monitoring Board set-up and use, Importance of Conflict of Interest Avoidance, What is "GCP", How to Document to have a good FDA Inspection, How to prepare for an FDA BIMO Inspection, The Importance of effective Pharmacovigilance.