Click here for information about our Principal Investigator Training

Our Clinical Research Education Program was designed specifically to introduce the concepts and requirements of clinical research and to educate and prepare individuals to work in various roles within the clinical research industry.  These fields include: clinical research coordinators, clinical research associates, research nurses, regulatory coordinators and/or data coordinators. The course can also serve to sharpen the skills of the research professionals within your organization.

Course length: approximately 1 ½ days






Sample Agenda

 

9:00-9:15: Introductions

9:15-10:00: The Drug Development Process
  • Types of Research
  • Clinical Research: How Do We Accomplish this Goal?
  • Phases of Clinical Research
  • Common Obstacles

10:00-10:30: Principal Investigator Responsibilities
  • What is a Principal Investigator (PI)?
  • FDA Form 1572
  • GCP Guidelines for Investigators



10:30-10:45: BREAK

10:45-12:00: FDA Regulations in Clinical Research

  • Title 21 CRF – Food and Drug Administration

Reviewed Parts
  1. CFR Part 11: Electronic Records; Electronic Signatures
  2. CFR Part 50: Protection of Human Subjects
  3. CFR Part 54: Financial Disclosure by Clinical Investigators
  4. CFR Part 56: Institutional Review Boards
  5. CFR Part 312: Investigational New Drug Application
  6. CFR Part 812: Investigational Device Exemptions
  7. CFR Part 814: Premarket Approval of Medical Devices
  8. HIPAA: Guidelines and Requirements

Parts Not Reviewed
  1. CFR Part 314: Application for FDA Approval to Market A New Drug
  2. CRF Part 320: Bioavailability and Bioequivalence Requirements
  3. CFR Part 601: Licensing

12:00-12:15: ICH Guidelines for Good Clinical Practice
  • What Is GCP and How Do They Differ from FDA Regulations?

12:15-1:00: Informed Consent
  • What is Informed Consent?
  • FDA Requirements (Sample ICF Review)
  • Developing an Informed Consent Form



1:00-2:00: LUNCH

2:00-2:45: The Clinical Research Protocol
  • FDA/GCP Requirements
  • Working with the Clinical Research Protocol
  • Protocol Deviations
  • Protocol Compliance
  • Creating Tools that Aid in Protocol Adherence

2:45-3:15: Understanding Adverse Events
  • What is an Adverse Event?
  • What is a Serious Adverse Event?
  • Documenting and Reporting Adverse Events

3:15-3:30: Source Documentation
  • What are Source Documents?
  • Examples of Source Documents Used in Clinical Research
  • How to Maintain Adequate Source Documentation
  • What are Sponsor Companies Looking For?



3:30-3:45: BREAK

3:45-4:00: Essential Documents
  • What are Essential Documents?
  • FDA/GCP Regulatory Requirements
  • Maintaining Essential Documents
  • Communicating and Corresponding with the IRB

3:45-4:00: Addressing Protocol Deviations
  • What are protocol deviations?
  • How should they be addressed?
  • How to minimize protocol deviations and maximize protocol adherence

4:00-4:30: Non-Compliance, Fraud and FDA Suspension

4:30-5:00: The Role of the Clinical Research/Data Coordinator

5:00: Questions, Discussion

—————- Day Two ———————

8:00-9:00: Completing the Case Report Form/Data Collection
  • General Requirements
  • Case Report Form Guidelines
  • Case Report Form Review
  • Checks and Balances

9:00-10:00: Audits


Call or contact us online for course availability and pricing information. Fee includes handbook of materials presented, FDA regulations, Basic Good Clinical Practices


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