Answer Happy

1 The investigational new drug regulations are in full effect during the conduct of a behavioral research study OA TRUE OB FALSE 2 The holder of the IND application, usually the company, institution or investigator who submitted the application, is called the ___ of the IND. O A Sponsor OB Monitor OC Study Physician OD Partner 3 A study conducted in a small number of participants, with a specific disease and investigating a number of doses of a drug to assess safety, is usually considered a study O A Phase 1 OB Phase 2 OC. Phase 3 OD. Phase 4

In the US Food and Drug Administration (FDA) regulations, an investigational new drug is: OA No substance seeking FDA approval OB Any substance (such as, a drug, vaccine or biological product) for which FDA approval is being sought OC Generic of a branded drug OD. All of the above 5 An Investigator participating in a clinical trial is responsible for protecting the rights, safety, and welfare of trial participants. Part of this responsibility is: O A Ensuring all subjects are consented appropriately and documented using the IRB approved informed Consent form OB. Making sure that target enrollment goals are met OC Enrolling subjects into the study who meet the exclusion criteria OD. Ensuring that the names of all subjects participating in the study are available to the general public