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Norton Audits Completes 5 Year Sepsis Study Auditing Contract
18 Audits Conducted from 2011 through 2017
Norton Audits Completes Investigator Systems Consulting
Focus in Quality and Marketing Leads to New Business Model


Clinical Research Training

from the










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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