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Role-Based Training
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Monitor Role-Based Package

For: New monitors and those who need to review the fundamentals of clinical research regulations

Objectives:
Provide an understanding of clinical research procedures and requirements that is based in regulations. Help monitors prioritize tasks during site visits and help the trial progress while off site. Understand what FDA inspectors need to know and be able to provide them with information as requested. Gain the confidence to answer questions or challenges regarding research procedures.

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

Upon successful completion of this course package, learners will receive 10.5 continuing education contact hours.


Courses:

a.    Monitoring Overview - (40 minutes)

b.    Foundation Package                            
    i.    An Introduction to the U.S. FDA Regulations
        1.     Part I: 21 CFR Part 312 and 812 - (55 minutes)
        2.     Part II: 21 CFR Parts 50, 56, 54, and 11 - (40 minutes)
        3.     Comparing 21 CFR Parts 312 and 812 - (55 minutes)
                                       
    ii.    Good Clinical Practice
        1.     The History of Clinical Research - (60 minutes)
        2.     Introduction to Good Clinical Practice - (40 minutes)
        3.     The FAIR Shake(TM) Method  - (35 minutes)
                                
    iii.    Human Subjects Protection
        1.     Human Subjects Protection: Drilling Down 21 CFR Part 50 - (40 minutes)
        2.     Introduction to HIPAA/HITECH - (40 minutes)

c.    Monitoring 101 Package
    i.    Site Assessment Visits - (55 minutes)
    ii.   Site Initiation Visits - (45 minutes)
    iii.  Periodic Monitoring Visits - (45 minutes)
    iv.  Close-Out Visits - (30 minutes)
    v.   Site Management - (30 minutes)

d.    Monitoring 102 Package
    i.     How to Review Informed Consent - (35 minutes)    
    ii.    How to Review Essential Documents - (40 minutes)
    iii.   How to Verify Source Data - (45 minutes)
    iv.   How to Conduct Product Accountability - (40 minutes)
    v.    Risk-Based Monitoring Overview - (45 minutes)
USD $425.00
Advanced Monitor Package
FOR:
Experienced monitors looking to expand their knowledge and skills.

OBJECTIVES:
Apply the quality assurance techniques of auditors to monitoring. List six core critical thinking skills and identify active processes for applying critical thinking skills in research studies. Understand risk-based monitoring approaches and best practices for developing plans. Explain approaches for effectively dealing with challenging research sites to maintain compliance.

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

Upon successful completion of this course package, learners will receive 4.5 continuing education contact hours.

COURSES:
a. Monitoring with an Auditing Perspective - (45 minutes)
b. Critical Thinking in Clinical Research - (60 minutes)
c. Risk-Based Monitoring (RBM) Overview - (45 minutes
d. Developing a RBM Plan - (60 minutes)
e. Adverse Event Reporting and Classification - (45 minutes)
f. Dealing With Difficult Sites - (45 minutes)

USD $210.00
Research Coordinator Role-Based Package

For: New research coordinators and those who need to review the fundamentals of clinical research regulations

Objectives:
Introduce new or aspiring research coordinators to their roles and responsibilities within a clinical trial and provide a thorough understanding of the regulations they rely on to perform their duties. Understand how to protect research subjects and how and when to report adverse events.

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

Upon successful completion of this course package, learners will receive 5.75 continuing education contact hours.

Courses:

a.    Research Coordinator Overview

b.     Foundation Package 
         i.     An Introduction to the U.S. FDA Regulations
             1.     Part I: 21 CFR Part 312 and 812 - (55 minutes)
             2.     Part II: 21 CFR Parts 50, 56, 54, and 11 - (40 minutes)
             3.     Comparing 21 CFR Parts 312 and 812 - (55 minutes)
 
         ii.     Good Clinical Practice
             1.     The History of Clinical Research - (60 minutes)
             2.     Introduction to Good Clinical Practice - (40 minutes)
             3.     The FAIR Shake(TM) Method  - (35 minutes)
 
         iii.     Human Subjects Protection
             1.     Human Subjects Protection: Drilling Down 21 CFR Part 50 - (40 minutes)
             2.     Introduction to HIPAA/HITECH - (40 minutes)

c.    Adverse Event Classification and Reporting - (45 minutes)

USD $250.00
Principal Investigator Role-Based Package

For: New and experienced Investigators who need training on their research responsibilities. The Foundation Package is included to provide a solid knowledge base for conducting clinical research with human subjects.

Objectives:
Learners will be able to describe the responsibilities of a principal investigator, understand the requirements they must follow when conducting a clinical study, understand how responsibilities may be delegated to other study personnel with proper oversight, and recall common warning letter findings. The Foundation Package includes two introductory courses on the FDA regulations, a good clinical practice course with an overview of the history of clinical research, a course in human subjects protection, and our signature FAIR Shake(TM) technique, which teaches the learner to take an otherwise complicated maze of requirements and break them down into four simple areas that can be applied to solving clinical research questions.  Understand how to protect research subjects and how and when to report adverse events. 

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

Upon successful completion of this course package, learners will receive 8 continuing education contact hours.


Courses:

a.    Principal Investigator Overview - (50 minutes)

b.    Foundation Package                            
    i.    An Introduction to the U.S. FDA Regulations
        1.     Part I: 21 CFR Part 312 and 812 - (55 minutes)
        2.     Part II: 21 CFR Parts 50, 56, 54, and 11 - (40 minutes)
        3.     Comparing 21 CFR Parts 312 and 812 - (55 minutes)
                                       
    ii.    Good Clinical Practice
        1.     The History of Clinical Research - (60 minutes)
        2.     Introduction to Good Clinical Practice - (40 minutes)
        3.     The FAIR Shake(TM) Method  - (35 minutes)
                                
    iii.    Human Subjects Protection
        1.     Human Subjects Protection: Drilling Down 21 CFR Part 50 - (40 minutes)
        2.     Introduction to HIPAA/HITECH - (40 minutes)

c.    Adverse Event Classification and Reporting - (45 minutes)
USD $300.00
Project Manager Package
Project Manager Package

For: New clinical research Project Managers or those without formal training looking to review important concepts in running compliant studies and demonstrate understanding.

Objectives: Compare and contrast the key roles in a research study including the Project Manager, Monitor, Investigator, and Research Coordinator.

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

Upon successful completion of this course package, learners will receive 8 continuing education contact hours.


Courses:

Project Manager Overview - (45 minutes)
Monitor Overview - (35 minutes)
PI Overview - (50 minutes)
RC Overview - (30 minutes)
The FAIR Shake Method - (35 minutes)
FDA Inspectional Findings - (55 minutes)
Maintaining the Sponsor TMF - (55 minutes)
RBM Overview - (45 minutes)
Developing a RBM Plan - (60 minutes)
Dealing With Difficult Sites - (45 minutes)
Critical Thinking in Clinical Research - (60 minutes)
USD $375.00
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