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Module 1: The Drug Development Process |
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The Goal of Clinical Research
Preclinical and Clinical Research
Phases of Clinical Research
The Process of Developing a Drug through Clinical Research
Common Obstacles |
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Module 2: The Role of the Principal Investigator |
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What is a Principal Investigator (PI)?
FDA Form 1572
Principal Investigator Responsibilities
GCP Guidelines for Investigators |
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Module 3: Informed Consent |
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What is Informed Consent?
FDA Requirements (Sample ICF Review)
Developing and Informed Consent Form |
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Module 4: The Clinical Research Protocol |
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FDA/GCP Requirements
Working with the Clinical Research Protocol
Protocol Deviations
Protocol Compliance
Creating Tools that Aid in Protocol Adherence |
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Module 5: Understanding Adverse Events |
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What is an Adverse Event
What is a Serious Adverse Event
Documenting and Reporting Adverse Events
IND Safety Reports |
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Module 6: Source Documentation |
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What are Source Documents?
Examples of Source Documents Used in Clinical Research
How to Maintain Adequate Source Documentation
What are Sponsor Companies Looking For? |
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Module 7: Essential Documents |
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What are Essential Documents?
GCP Guidelines for Essential Documents
Maintaining Essential Documents
Communicating and Corresponding with the IRB |
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Module 8: Non-Compliance, Fraud and FDA Suspension |
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What is Noncompliance?
What is Fraud?
Why the FDA may Disqualify an Investigator
4FDA Disqualification Process
An Example of an FDA Warning Letter
Clinical Investigator Inspection List, FDA Investigator Disqualification List, List of Assurances Accepted for Future Performance of Studies with Investigational Product |
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Appendix 1: |
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FDA Regulations in Clinical Research
Title 21 CRF – Food and Drug Administration |
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CFR Part 11: Electronic Records; Electronic Signatures
CFR Part 50: Protection of Human Subjects
CFR Part 54: Financial Disclosure by Clinical Investigators
CFR Part 56: Institutional Review Boards
CFR Part 312: Investigational New Drug Application
CFR Part 314: Application for FDA Approval to Market a New Drug
CFR Part 320: Bioavailability and Bioequivalence Requirements
CFR Part 601: Licensing
CFR Part 812: Investigational Device Exemptions
CFR Part 814: Premarket Approval of Medical Devices |
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Appendix 2: |
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Guidance for Industry E6
Good Clinical Practice Consolidated Guidance
ICH 1996 |
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Introduction
Glossary
The Principles of ich GCP
IRB/IEC
Investigator
Sponsor
Clinical Trial Protocol
Investigator’s Brochure
Essential Documents |
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Appendix 3: |
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Sample Informed Consent Form |
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Print This Agenda: Printer Friendly |
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