Are you a Compliant Principal Investigator? What you Must Know and Do to Ensure Trial Compliance (Clinical Training)
Venue: Online Event
|Event Date/Time: Aug 11, 2011||End Date/Time: Aug 11, 2011|
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. The responsibilities are clearly described / outlined in The ICH GCP Guidelines of E6 (4.1 to 4.13).
This training, by a 20-year industry veteran, will cover the regulations and the PI's responsibilities for both drug and device clinical research in a user friendly way.
Areas Covered in the Seminar:
- ICH guidelines and Good Clinical Practice (GCP).
- The legal language of the FDA form 1572.
- Role and Responsibility of the Principal Investigator.
- Why investigator needs to sign and date documents? What documents?
- Research Team management.
- Key aspects of the role and key players involved in a trial.
- Activities that are common to most trials.
- Why is Financial Disclosure information important?