Principal Investigator Training

This program is a one-day intensive course designed for clinicians who
will be assuming principal investigator responsibilities for clinical trials.

Upon completion of this course, clinicians will be competent and possess the valuable skills needed
in order to conduct a well organized
and controlled clinical research study within their institution and/or
private practices.

Fee: Call or contact us on line for course availability and pricing information. Fee includes handbook
of materials presented, FDA regulations, Good Clinical Practice.

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Clinical Research Coordinator Training


	9:00-9:15: Introductions
	9:15-10:00: The Drug Development Process:
1. 2. 3. 4.	Types of Research Clinical Research: How Do We Accomplish this Goal? Phases of Clinical Research Common Obstacles
	10:00-10:45: Principal Investigator Responsibilities
1. 2. 3.	What is a Principal Investigator (PI)? FDA Form 1572 GCP Guidelines for Investigators

	10:45-11:00: BREAK

	11:00-12:00: FDA Regulations in Clinical Research Title 21 CRF � Food and Drug Administration
	Reviewed Parts
1. 2. 3. 4. 5.	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
	Parts Not Reviewed
1. 2. 3. 4. 5.	CFR Part 314: Application for FDA Approval to Market A New Drug CRF Part 320: Bioavailability and Bioequivalence Requirements CFR Part 601: Licensing CFR Part 812: Investigational Device Exemptions CFR Part 814: Premarket Approval of Medical Devices
	12:00-12:15: ICH Guidelines for Good Clinical Practice
1.	What Is GCP and How Do They Differ from FDA Regulations?
	12:15-1:00: Informed Consent
1. 2. 3.	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
1. 2. 3. 4.	FDA/GCP Requirements Working with the Clinical Research Protocol Protocol Deviations Protocol Compliance
	2:45-3:15: Understanding Adverse Events
1. 2. 3.	What is an Adverse Event? What is a Serious Adverse Event? Documenting and Reporting Adverse Events
	3:15-3:30: Source Documentation
1. 2. 3. 4.	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
1. 2. 3. 4.	What are Essential Documents? FDA/GCP Regulatory Requirements Maintaining Essential Documents Communicating and Corresponding with the IRB
	4:00-4:30: Non-Compliance, Fraud and FDA Suspension
	4:30: Questions, Discussion

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To enroll in our principal investigator training program or to request more information please contact us at (508) 865-8907 or through our online form for specific service information and pricing. Other training programs are available through CRCI upon request.

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