Clinical Research Coordinator Training

The clinical research coordinator training is a one and one-half day course designed for any individual who will be working and assuming working responsibilities as a clinical research coordinator.

Upon completion of the clinical research coordinator training course, participants will be competent and possess the valuable skills needed in order to conduct a well organized and controlled clinical research study within their institution.

Fee: Call or contact us on line for course availability and pricing information. Fee includes handbook of all materials presented, FDA Regulations, ICH Guidelines and Good Clinical Practices.

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Principal Investigator 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
	10:00-10:30: Principal Investigator Responsibilities
1. 2. 3.	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. 2. 3. 4. 5. 6. 7. 8.	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 812: Investigational Device Exemptions CFR Part 814: Premarket Approval of Medical Devices HIPAA: Guidelines and Requirements
	Parts Not Reviewed
1. 2. 3.	CFR Part 314: Application for FDA Approval to Market A New Drug CRF Part 320: Bioavailability and Bioequivalence Requirements CFR Part 601: Licensing
	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. 5.	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
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
	3:45-4:00: Addressing Protocol Deviations
1. 2. 3.	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
1. 2. 3. 4.	General Requirements Case Report Form Guidelines Case Report Form Review Checks and Balances
	9:00-10:00: Audits

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To enroll in our clinical research coordinator 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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