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Individual Courses
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Good Clinical Practice

This course provides an introduction to the main tenets of good clinical practice as well as a history of clinical research and the importance of research standards. The FAIR Shake Method is included to give learners a tool for applying critical thinking skills to difficult compliance questions.

Objectives:
Learners will be able to recall significant events in history that influenced clinical research, match significant advances in regulation to what caused them, and explain the continued importance of research regulations.

Learners will be able to define and explain Good Clinical Practice, identify the various guidelines and standards that comprise GCP, and describe the principles of the Belmont Report.

Learners will be able to recall the elements of the FAIR Shake Method, apply the method to potential compliance concerns, and understand the importance of supporting recommendations with the FAIR Shake Method.

Upon successful completion of this course, learners will receive 1.75 continuing education contact hours.

Sessions Included:
    1.     The History of Clinical Research - (60 minutes)
    2.     Introduction to Good Clinical Practice - (40 minutes)
    3.     The FAIR Shake(TM) Method - (35 minutes)

USD $88.00
Introduction to the US FDA Regulations

This course covers the US FDA regulations pertaining to research in Title 21 of the Code of Federal Regulations. The parts covered include 312, 812, 50, 54, 56, and 11. This course also includes a comparison between parts 312 and 812 for drug and device studies regulations.

Objectives:
Learners will understand regulation of investigational new drugs and investigational devices by the FDA, and explain the responsibilities of Sponsors and Investigators in Investigational New Drug and Investigational Device Exemption studies. 

Learners will understand the role of informed consent in ensuring human subject protection, the required elements of and documentation process for informed consent, the requirements for IRB composition, operation and compliance, the goals of disclosing financial interest, and required controls for electronic records and signatures.

Learners will review the key requirements of 21 CFR Parts 312 and 812, identify the primary similarities and differences, and understand the development pathways of new drugs and new devices.

The approximate time to complete each session and quiz is noted next to each topic.

Upon successful completion of this course, learners will receive 2.00 continuing education contact hours.


Sessions Included:
    1.     Introduction to the US FDA Regulations Part I: 21 CFR Parts 312 and 812 - (55 minutes)
    2.     Introduction to the US FDA Regulations Part II: 21 CFR Parts 50, 54, 56, and 11 - (40 minutes)
    3.     Comparing 21 CFR Part 312 and 21 CFR Part 812 - (55 minutes)

USD $100.00
FDA Inspections
This course provides learners with information about why, when, and how FDA inspections of clinical investigation sites and sponsors occur. Learners will gain a detailed understanding of the FDA’s compliance program guidance manual, the items assessed by FDA inspectors, and best practices to help research teams prepare for and host inspections.

Objectives:
Learners will understand how to prepare for and host an FDA inspection, comprehend potential inspection outcomes for investigators, describe key topics assessed in the FDA’s BIMO Guidelines for Site inspections and connect these with examples of evidence the FDA will review, and understand the guideline as a foundation for quality assurance activities.

The approximate time to complete each session and quiz is noted next to each topic.

Upon successful completion of this course, learners will be eligible to receive 2 continuing education contact hours.

Sessions Included:
    1.     FDA Inspections 101 - (55 minutes)
    2.     FDA Inspections 102 - (55 minutes)

USD $100.00
Human Subjects Protection
This course examines human subjects protection in more detail, with an in-depth look at 21 CFR Part 50 as well as an introduction to the HIPAA and HITECH regulations. Learners will gain a thorough understanding of the important role of informed consent and privacy protections in clinical research.

Objectives:
Learners will be able to describe the steps required for obtaining proper informed consent according to the regulations, list the requirements for documentation of the informed consent process, and recall the basic and additional elements of informed consent.

Learners will be able to describe HIPAA and HITECH legislative acts, list individually identifiable data elements that are protected under HIPAA and HITECH, and explain the impact that HIPAA and HITECH have on clinical research.

The approximate time to complete each session and quiz is noted next to each topic.

Upon successful completion of this course, learners will be eligible to receive 1 continuing education contact hour.


Sessions Included:
    1.     Human Subjects Protection: Drilling Down 21 CFR Part 50 - (40 minutes)
    2.     Introduction to HIPAA and HITECH - (40 minutes)

USD $50.00
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