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Training Packages
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Foundation Package
For: Sponsor organizations and their project managers, sales professionals, research coordinators, monitors and anyone else involved in the clinical research process

Objectives: Provide a solid knowledge base for conducting clinical research with human subjects.  Includes two introductory courses on the FDA regulations. One session covers 21 CFR Parts 312 and 812, and the other covers 21 CFR Parts 50, 56, 54, and 11.  It also includes a course comparing 21 CFR Parts 312 and 812. Additionally, the Foundation Package includes good clinical practice with an overview of the history of clinical research.  The Human Subjects Protection course reviews 21 CFR Part 50 in more detail as well as HIPAA in research. The Package also includes a course on 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. 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 4.75 continuing education contact hours.

Courses:

a.    An Introduction to the U.S. FDA Regulations                                  
             
           i.    Part I: 21 CFR Part 312 and 812  - (55 minutes)
             
           ii.   Part II: 21 CFR Parts 50, 56, 54, and 11  - (40 minutes)                                   
             
           iii.  Comparing 21 CFR Parts 312 and 812  - (55 minutes)

b.    Good Clinical Practice

           i. The History of Clinical Research - (60 minutes)

           ii. Introduction to Good Clinical Practice - (40 minutes)

           iii. The FAIR Shake Method (35 minutes)

c .    Human Subjects Protection
 
           i. Human Subject Protection: Drilling Down 21 CFR Part 50 (40 minutes)

           ii. Introduction to HIPAA/HITECH (40 minutes)



USD $215.00
Monitoring 101 Package
For: New monitors or monitors who need to review regulations

Objectives: Provide the learner with an overview of what it means to be a clinical research monitor. Understand the four traditional types of monitoring visits: Site Assessment, Site Initiation, Periodic, and Close-Out.  Learn what to do between visits to help a clinical trial progress.

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 2.5 continuing education contact hours.

Courses:

a.    Site Assessment Visits - (55 minutes)

b.    Site Initiation Visits - (45 minutes)

c.    Periodic Monitoring Visits - (45 minutes)

d.    Close-Out Visits - (30 minutes)

e.    Site Management - (30 minutes)

USD $115.00
Monitoring 102 Package
For: New monitors who have taken Monitoring 101 or experienced monitors who want to dive deeper into the requirements for informed consent, documents review, source data verification and more.

Objectives: Increase competency on and off site. Be able to think critically and spot potential errors before they become violations.

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 2.5 continuing education contact hours.

Courses:

a.    How to Review Informed Consent - (35 minutes)

b.    How to Review Essential Documents - (40 minutes)

c.    How to Verify Source Data  - (45 minutes)

d.    How to Conduct Product Accountability - (40 minutes)

e.    Risk-Based Monitoring Overview - (45 minutes)
USD $115.00
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