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On-Line

Clinical Research Training

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OUR ONLINE TRAINING SYSTEM IS CURRENTLY UNDERGOING A MAJOR UPGRADE AND UNFORTUNATELY IS NOT AVAILABLE.

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No time or travel budget to attend one of our Public Training Classes ?

 

Looking for the latest Skills and Knowledge to advance your career?

 

Need training you can complete any time of the day, week, or weekend?

 

Need audio, visual, and hands-on elements to maximize training effectiveness?

 

Then the  Norton Training Institute On-Line Training  may be what you are looking for:

  • Developed by Former FDA Investigators and Current Industry Auditors, Instructors and Consultants
  • On-Line Internet-Based Subscription Training
  • Available 24/7 during your Subscription
  • Start, Pause, Restart and Repeat Training as often as you like
  • Training Includes Audio, Visual and Hands-On Content:
    • Instructor Narration over Graphical Text
    • Digital Library of Reference Materials
    • Terms Glossary
    • Frequently Asked Questions
    • Area to Record your Personal Training Notes
    • Pass/Fail Quizzes to Ensure Learning
    • Personal Training Certificate
  • Simple and User-Friendly Interface.  Try our free Learner Demonstration or CAPA On-Line Training
  • The same Elements of our other Training Offerings
    • Focus on Teaching Usable Skills
    • Applicable Laws, Regulation, GCP and ICH References
    • Real World Experience-Based Case Studies
  • Generally 1 to 4 Hours in Length 

 

 "I have completed the NT20 Clinical Research Associate Program. It was very interesting and an glad I took the course. The information was presented clearly and was made understandable. Again, thnak you for your dedication to Clinical Research!" Janice; CRA Program On-Line Student, July, 2012



 

 

 

"I highly enjoyed these courses and if I get the opportunity to take additional training, I definitely want to complete the audit program.  Thank you again!" Robert; CRA and On-Line Student, March, 2012



  

Modules Available Now :

  • Technical Writing Skills and Clinical Audit Reports
    • The first industry training program developed to specifically address skills for writing clinical research audit reports.
    • Module 1: The Purpose, Style and Prose of Audit Reporting
    • Module 2: Establishing a Framework for Technical Clinical Audit Reports
    • Module 3: Methods for Technical Clinical Audit Reports and Summation Technique®
    • Module 4: Examining Case Studies
  • Introduction to Clinical Reserach Monitoring
    • Learn the History of Clinical Investigations
    • Understand the Complete Drug Development Process
    • Explains the Purpose and Objectives of Monitoring Clinical Trials
    • Presents the Requirements for Monitoring Established by Regulations and Federal Law
  • Conducting a Clinical Investigator Qualification Visit
    • Identifying Compliance Concerns Upfront, before Research is Conducted
    • Teaches the Systematic Skills for Inspecting a Clinical Investigator, Including:
      • Interviewing, Human Research Protection
      • Quality Systems, Training, Form FDA 1572
      • Equipment, Staff and Regulation Knowledge
  • Noncompliance Causalities and Securing Compliance at the Clinical Investigator
    • Presents the Key Quality Systems for Investigators

    • Major trends of Clinical Investigator Noncompliance

    • Examine why Noncompliance occurs within Clinical Trials

    • Implementing Corrective and Preventative Actions  (CAPA)

    • Four Hours of Core Content plus Research Assignments

    • For Auditors, Monitors, Coordinators, Investigators and Site Staff

  • Issue Resolution Techniques: R.E.S.E.A.R.C.H. Skills
    • An 8 Step Process for Examining and Determining Follow-Up to Noncompliance

    • A Framework for Issue Resolution and Case Development

    • Case Studies on a CRO, Phase I Facility Inspection and Phase III Clinic Data Audit

    • Provides Step-by-Step Skills for Handling Suspect Data and Scientific Misconduct 

    • Four Hours of Core Content plus Quizzes, Digital Library and Glossary

    • For Auditors, Monitors and Investigators

 

 "I love the whole course style, interface, visuals, and the audio. I like your program better than my online Masters Program." Ronjula; CRA Program On-Line Student, June, 2009



 

  • Sensitivity to Clinical Research Fraud and Misconduct
    • Famous Cases
    • Legal, FDA and ICH Definitions
    • Detection, Prevention and Causation
    • Who is Blamed for and Who Commits
    • Whistleblower and False Claims Laws
    • Umbrella of Protection to Prevent and Detect
    • FDA Process for Responding to Claims and Complaints
    • How to Document, Burden of Proof and Elements to Prove
    • Responsibilities of Sponsors, CROs, IRBs, and Investigators
  • Legal Training for Determining Qualifications of Clinical Investigators 
    • Build regulatory and legal skills
    • Understanding of binding and legal agreements between:
      • FDA
      • Sponsor
      • IRB
      • Clinical Investigator
      • Study Team
    • Learn laws governing the investigator's necessary qualifications for:
      • Receiving investigational drugs
      • Conducting clinical research
    • Examine laws as related to determining investigator's qualifications to receive and treat with investigational drugs:
      • 21 Title CFR 312
      • FDA's Compliance Policy Program 7248.811
      • Form FDA-1572
      • International Conference on Harmonisation (ICH)

   

Complete Training Programs Available Now:  

Clinical Research Associate

  • 20 Individual Training Modules totaling approximately 40 hours of training content
  • For the Entry-Level Clinical Research Associate/Monitor or Experienced Monitor that Needs Formal Training
  • Training Modules Cover:
    • Good Clinical Practices, Medical Ethics, Terminology
    • Drug and Device Development Process, Investigator Brochures
    • US FDA 21 CFR, International ICH and other Industry Regulations and Regulatory Documents, Protocols and FDA Form 1572
    • Institutional Review Boards, Clinical Investigator Qualification Visits, Drug and Device Accountability
    • Human Subject Rights, Safety and Protection
    • Monitoring Visit Process, Site Initiation, Data Management, Report Writing Skills, Close-Out Meetings
    • Adverse Event and Effects Handling
    • Fraud and Misconduct Sensitivity   

Clinical Research Coordinator

    • 12 Individual Training Modules totaling approximately 6 hours of training content
    • For the Entry-Level Clinical Research Coordinator or Experienced Coordinator that Needs Formal Training

 

 

"I had a VERY non-compliant site and using your methods and ideas, I was able to bring them back into compliance (and exceed the ICH/GCP). They just had an audit and the person conducting the audit was very impressed with our hard work. Norton Training has been a God send!" Marti; Senior CRA and On-Line Student, May, 2007

For more information or Assistance in Course Registration, please contact us.

 


"Your on-line demo is great.  It gave me the confidence in what I was paying for and we really like the fact that each module is narrated."   Jen; CRO Owner and On-Line CRA Program Customer, February, 2006

 
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