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Clinical Research Coordinator Training

Clinical Research Coordinator Training Agenda

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

Clinical Research Coordinator Training agenda
  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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