Online Clinical Research Coordinator Training / Education

This program is designed for clinical research coordinators assuming coordinating responsibilities for
clinical trials.

Upon completion of this course, coordinators 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: $1,100
Fee includes FDA Regulations, ICH Guidelines and Good Clinical Practices.

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Online Clinical Research Principal Investigator Training


		Module 1: The Drug Development Process
1. 2. 3. 4. 5.		The Goal of Clinical Research Preclinical and Clinical Research Phases of Clinical Research The Process of Developing a Drug through Clinical Research Common Obstacles

		Module 2: The Role of the Principal Investigator
1. 2. 3. 4.		What is a Principal Investigator (PI)? FDA Form 1572 Principal Investigator Responsibilities GCP Guidelines for Investigators

		Module 3: Informed Consent
1. 2. 3.		What is Informed Consent? FDA Requirements (Sample ICF Review) Developing and Informed Consent Form

		Module 4: 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

		Module 5: Understanding Adverse Events
1. 2. 3. 4.		What is an Adverse Event What is a Serious Adverse Event Documenting and Reporting Adverse Events IND Safety Reports

		Module 6: 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?

		Module 7: Essential Documents
1. 2. 3. 4.		What are Essential Documents? GCP Guidelines for Essential Documents Maintaining Essential Documents Communicating and Corresponding with the IRB

		Module 8: Audits
1. 2. 3. 4. 5.		Audits in General Quality Assurance (QA)/Sponsor Audits History of FDA Auditing Program FDA Audits Surviving QA/Sponsor and FDA Audits

		Module 9: Non-Compliance, Fraud and FDA Suspension
1. 2. 3. 4. 5. 6.		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

		Module 10: Completing the Case Report Form/Data Collection
1. 2. 3. 4.		What is a Case Report Form? Case Report Form Guidelines How to Complete a Case Report Form Checks and Balances

		Appendix 1:
			FDA Regulations in Clinical Research Title 21 CRF – Food and Drug Administration
1. 2. 3. 4. 5. 6. 7. 8. 9. 10.			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

		Appendix 2:
			Guidance for Industry E6 Good Clinical Practice Consolidated Guidance ICH 1996
1. 2. 3. 4. 5. 6. 7. 8. 9.			Introduction Glossary The Principles of ICH GCP IRB/IEC Investigator Sponsor Clinical Trial Protocol Investigator’s Brochure Essential Documents
		Appendix 3:
			Sample Informed Consent Form

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

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