InvestigatorandStudyCoordinatorResponsibilitiesAFocus.pptVIP

Investigator and Study Coordinator Responsibilities: A Focus on FDAs Final Guidance ;FDA Responsibilities;Investigator Responsibilities for FDA Regulated Research;FDA Final Guidance on Investigator Responsibilities;Subject’s Health, Safety, and Welfare;PI Responsibilities For Ensuring Human Subjects Protections;Providing Reasonable Medical Care;Incidental Findings In Research;Providing Reasonable Access to Medical Care ;Adhering to the Protocol ;Ensuring clinical investigation is conducted according to ;Following Good Clinical Practice (GCP);Following Investigational Plan;Adhering to Statement of Investigator;Small Print of the 1572;Supervision of Delegated Tasks: FDA Warning Letters;Noncompliance With GCP;PI Delegation;FDA Focus in Assessing Adequacy of Supervision;Delegation of Study-Related Tasks;Protocol Requirements;Inappropriate Delegation: FDA Warning Letters;Goals of Adequate Training;Adequate Training Documentation;Adequate Supervision of the Conduct of an Ongoing Clinical Trial;Adequate Supervision: Warning Signs;Investigator’s Responsibilities for Oversight of Third Parties ;FDA Warning Letters;Richard Borison, PhD and Bruce Diamond, MD Case;Wall Street Journal Headlines;Inappropriate Delegation to Study Coordinators;Inappropriate Supervision of Coordinators;Results of FDA Investigation;Robert Fiddes, MD Case;Inexperienced Study Coorindators;Inappropriate Actions of Study Coordinators with Delegated Duties;Dr. Fiddes Defense;Who’s Responsible;Inadequate Government and Sponsor Monitoring? ;FDA Timeline for Dr. Fiddes;FDA Inspections- Triggered by Investigator Action;Final Advice;Questions?