New Investigator Training

Last revised: 
07/15/2013

Guidance and Resources for New Investigators - Courses & Descriptions 

Complete 5 CITI Good Clinical Practice Modules described below - http://www.citiprogram.org

  • CITI: FDA Regulated Research and ICH for Investigators - Addresses responsibilities of investigators, IRBs, and sponsors when they participate in a study of an FDA-regulated product.
  • CITI: Conducting Investigator-Initiated Studies According to FDA Regulations and GCP - Describes the role of sponsor-investigator, help determine whether an IND or IDE is required for your study, and indicate what documentation is required by the FDA.
     
  • CITI: Investigator Obligations in FDA-Regulated Clinical Research - Describes the commitments and obligations that investigators assume when participating in clinical investigations; to subjects, IRB, sponsor organization, and the FDA
     
  • CITI: Managing Investigational Agents According to GCP Requirements - Describes the responsibilities of investigators when using investigational products according to GCP standards.
     
  • CITI: Overview of U.S.FDA Regulations for Medical Devices - Describes the differences of research regulatory requirements for various classes and categories of devices.
     
  • CITI: Reporting Serious Adverse Events - Identify criteria for reporting serious adverse events (SAEs) to regulatory agencies and defines serious and unexpected events which require immediate reporting.
     
  • CITI: Audits and Inspections in Clinical Trials - Identifies different entities that can inspect or audit a clinical trial investigator and factors that determine whether an investigator will be audited
  • US Food and Drug Administration (FDA) clinical Investigator course 2012: Co-sponsored by FDA's CDER, Office of medical Policy and the Duke University School of Medicine.
     

    1. Good Clinical Practice (GCP) Key Topics by Jean Toth-Allen, PhD
      FDA Office of Good Clinical Practice-
      Investigator Responsibilities
      Clinical Investigator Financial Disclosures
      Expanded access to and charging for investigational drugs and devices 
      http://www.fda.gov/downloads/Training/ClinicalInvestigatorTrainingCourse/UCM337269.pdf
    2. Investigator Responsibilities-Regulation and Clinical Trials by Cynthia F. Kleppinger, M.D.
      Division of Good Clinical Practice Compliance
      Federal regulations covering clinical research and clinical investigator obligations
      Discuss specific problems seen during FDA inspections at clinical sites
      Discuss various methods that can be used to ensure compliance with federal regulations and study protocol 
      http://www.fda.gov/downloads/Training/ClinicalInvestigatorTrainingCourse/UCM337271.pdf
    3. Safety assessment in Clinical Trials and Beyond by Yuliya Yasinskaya, MD, Medical Officer, Center for Drug Evaluation and Research 
      Sources of safety information 
      Sources of safety information 
      Safety monitoring/ AE ascertainment· 
      AE Coding
      Safety Reporting
      Post-marketing safety (MedWatch) reporting
      http://www.fda.gov/downloads/Training/ClinicalInvestigatorTrainingCourse/UCM337224.pdf