On-Line

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
• CEUs Included with Every Course
• 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.  CEUs also available
• 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 

Modules Available Now :

• 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

Complete Training Programs Available Now:

Clinical Research Associate

• 10 - 15 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

Complete Training Programs Available Soon:

Clinical Research Coordinator

• • 10 - 15 Individual Training Modules totaling approximately 30 hours of training content
  • For the Entry-Level Clinical Research Coordinator or Experienced Coordinator that Needs Formal Training

Modules Available Soon Include :

Clinical Investigators and Research Coordinators

• Concepts of Delegation of Authority
• Corrective and Preventative Actions

Clinical Research Auditing 

• Trend Analysis Skills
• Auditing the Informed Consent Process
• Norton Methods: Skill-Based Auditing Techniques – Series One
• Norton Methods: Skill-Based Auditing Techniques – Series Two
• Norton Methods: Skill-Based Auditing Techniques – Series Three
• Examining Causality of Institutional Review Boards Noncompliance
• Examining Causality of Sponsor and Contract Research Organizations Noncompliance

Monitoring

• Inspecting Clinical Research Facilities
• Concepts of Quality Systems Methods of Monitoring
• Conducting Quality Systems Assessments of Clinical Investigators

Skills for All Clinical Research Professionals

• Complaint Management Skills
• Effective Regulatory Writing Skills
• Effective Professional Interviewing Skills
• Detection and Prevention of Fraud and Misconduct

Industry Basics and Trends

• Good Clinical Practice Law
• Expanding GCP to Incorporate ICH
• 2005 Clinical Research Noncompliance Trends

Standard Operating Procedures

• In Conjunction with our Offering of Standard Operating Procedures

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

• 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)