Course Description:

The many regulatory agencies charged with oversight of Clinical Research have exacting requirements to ensure the protection of study participants; and while there is overlap in goals there are differences in expectations and standards. The complex regulatory environment can be difficult to navigate, but understanding it is a necessity for all clinical research professionals. Compliance with all of the various regulatory requirements ensures safety of patients, quality of data and timeliness and efficiency of study completion. Historically clinical research has been carried out as a secondary interest of physicians, often by coordinators with little or no experience. Today, the standards for the professionalization of clinical research roles continues to grow through the certification of research professionals. Robust educational programs, such as this seminar form a solid foundation of principles needed for success as a research professional.

Learning Objectives:

  • Differentiate between the regulations that apply to FDA-regulated studies and those that apply to federally- funded studies
  • Define research with human subjects
  • Describe the typical activities and flow of a study
  • Describe different types of human subjects research
  • Define research misconduct
  • Describe the standard items addressed in a clinical trial agreement (CTA)
  • Describe Conflict of Interest (COI)
  • Identify key components of good documentation practices
  • Outline various safeguards for ensuring data integrity
  • Summarize the IRB scope of responsibilities and authority
  • Demonstrate the principles of confidentiality and privacy in all clinical research operations
  • Apply the key regulatory requirements and good clinical practices that apply in the protection of human subjects during the informed consent process
  • Apply the applicable regulations in the clinical research professional's role of identification, documentation, and reporting of Adverse Events and Unanticipated Problems
  • Recognize and take appropriate action when noncompliance is suspected or observed
  • Describe the compliant process for evaluating study billing

Seminar Fee Includes:

AM-PM Tea/Coffee
Seminar Material
USB with seminar presentation
Hard copy of presentation
Attendance Certificate
$100 Gift Cert for next seminar

Who will Benefit:

  • Healthcare providers interested in exploring the field of Clinical Research
  • New Clinical Research Coordinators (1-2 years)
  • New Principal Investigators
  • Administrative managers in charge of Clinical Research
  • Regulatory Compliance Associates and Managers

Course Outline:

Day 1 (8:30 AM – 4:30 PM) Day 2 (8:30 AM – 4:30 PM)
  • 8:30 – 9:00 AM: Registration
  • 9:00 AM: Session Start Time
  • Overview and Introductions
  • Understanding Federal Regulations and ICH GCP (International Conference on Harmonization- Good Clinical Practice)
    • Determining when an Activity Qualifies as Human Subjects Research
    • Types of Human Subjects Research
    • Comparing Drug and Device Development
  • Understanding the Lifecycle of Clinical Research
    • Start Up
    • Study Conduct
    • Close out
  • Understanding Roles and Responsibilities and Ensuring Compliance
    • Regulatory Requirements
    • Conflict of Interest
    • Research Misconduct
    • Noncompliance
    • Audits and Inspections
  • Understanding the Approval Process
    • Document Preparation
    • Working with IRBs (Institutional Review Boards)
  • Understanding Study Conduct, Documentation and Reporting
    • Source Documents
    • Regulatory Files
    • Informed Consent
    • Adverse Events
    • Privacy, Confidentiality and HIPAA
  • Understanding Agreements: CDA, CTAs, Grants
    • Terms
    • Cost Planning and Budgeting
  • Understanding Clinical Research Billing
    • The NCD (National Coverage Decision) and Third Party Payers
    • Charge Assignment Grids

Meet Your Instructor

Jennifer Holcomb,
Clinical Research Expert

Jennifer Holcomb,MA, CCRC, is a clinical research professional with 20 years of experience in the field. Currently employed by UCHealth, she provides guidance and leadership in the establishment and development of policies in the conduct and management of clinical research. Key areas of expertise include clinical trial budgeting and contract negotiations as well as regulatory knowledge including international ICH GCP standards. Jennifer has extensive experience in training and education and served as Vice Chair of the ACRP Professional Development Committee for 4 years ending in December 2013.

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Local Attractions

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