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Welcome
to the Norton Training Institute for Clinical Research Excellence
A Service of Norton Audits, Inc.
A Clinical Research Auditing, Training, Consulting and Publications Company
Learn more about us at www.nortonaudits.com
Contact us at:
onlinetrain@nortonaudits.com
803-233-4809 or toll free at 866-552-8832
Learn more about our live Public Training classes including GCP Auditing Forum here.
We offer you the most effective, accessible and complete on-line clinical research training in the industry. Our courses provide you immediately usable clinical research skills that are rooted in the legal and regulatory basis of compliance, and prepared by highly experienced and currently active field auditors, trainers and consultants.
We understand that Adult Learners need Verbal, Visual and Hands-On Training Content that is inspiring and challenging, yet simple to navigate. You will find that here.
Each program is formatted with:
• Instructor-Narrated Audio (verbal)
• Coinciding Graphical Slides (visual)
• Digital Library of Examples (hands-on)
• On-Line Graded Quizzes to ensure Understanding
• Training Certificates upon Completion of each Class
• Searchable Glossary of Terms
• Student-Specific Stored Learner Notes
• Instructor Chat
• Complete Technical Support
• High-Speed Internet Access with Audio is Required
The Instructors that have developed this On-Line Training are former FDA Investigators who know Regulations and Industry Good Clinical Practices, as well as highly experienced Industry Research Personnel that know the real world skills needed to conduct research on a daily basis at a Sponsor, CRO, IRB, Investigator or other research organization. This combination of regulation knowledge and real world case studies, skills, and experience is brought to life for you the student here with visual, audio, and hands-on education.
Our course offering continues to grow, so check back frequently for updates.
Please select your Individual Course or complete Training Program from the list to the right or from our complete Course Catalog link at bottom right.
If you have previously registered, please log in using the Username and Password displayed in your registration confirmation message.
"I love the whole course style, interface, visuals, and the audio. I like your program better than my online Masters Program." Ronjula; Current CRA Program Student, June, 2009
"I thought it was an excellent course and I learned so much more than
I could have thought to have known." Bryan; CRA and On-Line Student, January, 2008
"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 "I just finished the Noncompliance Causalities class and I loved it. I love what Norton Training has to offer. It lights a fire under me and pushes me to work harder and further educate my Study Coordinators and PI." Martha; Pharmaceutical CRA and On-Line Customer, March, 2007 "Enjoying the course. Its really great. Better than class room training. Really! I am really impressed with your immediate answers for queries and continuous evaluation of students and follow up." Samir; Pharmacist and Current On-Line Student from the country of Oman, May, 2007 "I have attached my test and FDA letter that I have selected for this test. This course is excellent. I am having a wonderful time learning about clinical research." Samina; On-Line CRA Program Student, June, 2007 "I have been a Coordinator for over 5 years and know GCPs quite well, yet your Intro to Monitoring Course still taught me things I didn't know and required me to look at the provided reference material in order to pass the test." Donna; Coordinator and Current CRA Program Student, January, 2007 "I am new to Norton training and just completed the online course 'Sensitivity to Clinical Research Fraud and Misconduct'. I enjoyed the ease of use of the online format and learned at lot." Linda; On-Line Student, June, 2006 "We own a small CRO and I have been searching for a good, high quality on-line CRA training program. Your on-line demo is great. It gave me confidence in what I was paying for and we really like the fact that each module is narrated." Jen; CRO Owner and On-Line Customer, February, 2006 "I have to say that I learned a lot. Going thru the FDA site's warning and NIDPOE letters was very interesting. Good and tough questions on the test. It made you really research things. Your web site is very easy to navigate and laid out well." Martha; Current On-Line Student, February, 2006 "I've completed the RESEARCH and now into the Causalities Class. I wish I had taken these months ago. I would have been better informed and more confident." Rita; On-Line Student, January, 2006 "I feel like there is somebody there and it is not just a class on the web. The opportunity for a chat was great. My overall impression is one of Norton Audits being a serious professional company. The class is easy to access and run." Michelle; On-Line Student, October, 2005 "Tongue nor heart to express my thirst to absorb clinical research monitoring." Nkeedu Ebong; On-Line Student from Africa, January, 2007 Individual courses are subscribed and sold for individual and not group use. Group sales are available by contacting us at onlinetrain@nortonaudits.com. All course content is copyright protected and not available for copy, download, or other use outside of this on-line training environment, excluding any library items which are accessible for printing. 
The University of South CarolinaAcademic Enrichment and Conferences at the University of South Carolina issues Continuing Education Units (CEUs) to those approved as successfully completing Norton Audits courses and seminars. CEUs permanently document your professional development and training experience and may be used to satisfy re-licensing or job recertification requirements. (c) 2009 Norton Audits, Inc. All Rights Reserved
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Course Catalogclick above
Complete Training Programs
Auditing Classes
Learn auditing from an auditing company, Norton Audits, a national and international clinical research auditing company. Various courses in auditing clinical research processes such as clinical investigations. Learn the regulations, skills and proven techniques to audit clinical research activities including
Report-Writing, detecting scientific misconduct and fraud, and addressing noncompliance. 5 Individual Training Classes Available Class prices range from $75 - 250 CEUs Available for additional cost
NT20: Clinical Research Associate Program
A complete Clinical Research Associate/Monitor Training Program for the new Monitor or experienced Monitor in need of formal training. Learn the regulations, skills and proven techniques to monitor clinical research trials from Investigator Qualification Visits, to Interim Monitoring, to Close-Out Visits, and everything in-between.
20 Training Modules Covering 40 hours of Training
$800.00
Pay-as-You-Go Programs Available
CEUs and Program Certificate Available
for additional cost
NT50: Clinical Investigator and Coordinator Operations GCP and ICH Training Series
Individual GCP and ICH Training Modules for the Entry-Level or Current Clinical Research Professional, Investigator and Coordinator. Purchase individually (see Course Catalog) or the entire Series (click title here). Each module provides a detailed description of the legal and regulatory requirements defined by Good Clinical Pratices for investigational research. A GCP and ICH certificate is provided for each module completed.
12 Training Modules Covering 8 Hours of Training
$275.00
Sample of Individual Courses
See our Course Catalog for complete course listing.
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Click on the course name
NT89: Norton Methods: Technical Writing Skills and Clinical Audit Reports
The first industry training program developed to specifically address skills for writing clinical research audit reports. This program is focused on Technical Writing Skills for Clinical Audit Reports and our Summation Technique®. Our primary focus is how to report audit results of clinical investigator audits. This program will help you with various types of audit reports including vendor audits. Effective writing skills are paramount for ensuring audit results are communicated properly for decisions and actions to be made and for keeping your organization informed.
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
4 hours of Education for the Clinical Research Auditor, Monitor and Quality Assurance personnel.
4.0 Contact Hours or 0.4 CEUs
$250.00
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NT04: Noncompliance Causalities and Securing Compliance at the Clinical Investigator
This course provides an understanding of the major trends of noncompliance within Clinical Investigator operations and presents the concept of effective Quality Systems to prevent noncompliance. This course also introduces skills for implementing a Corrective and Preventative Action (CAPA) program at the Clinical Investigator that addresses current noncompliance.
4 hours of Education for Clinical Trial Auditors, Monitors, Coordinators and Site Staff.
4 Contact Hours or 0.4 CEUs
$175.00
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NT03: Issue Resolution Techniques: R.E.S.E.A.R.C.H. Skills
The Norton Method R.E.S.E.A.R.C.H.™ Skills Program is an eight step process of field-proven techniques for answering, examining and determining the follow-up to noncompliance issues through a framework for ensuring issue resolution and establishing case development evidence for severe noncompliance, suspect data or reporting scientific misconduct. The program is structured to implement investigative skills, proper documentation and assessment such that occurrences can be objectively evaluated and reported without personal reactions and view points that may interfere with proper assessments of events. Step-by-step case studies are also examined in detail for a Contract Research Organization, Phase 1 Facility Inspection and Phase 3 Clinical Data Audit.
4 hours of Education for Clinical Trial Auditors, Monitors and Investigators.
4 Contact Hours or 0.4 CEUs
$175.00
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NT27: Sensitivity to Clinical Research Fraud and Misconduct
Gain a better understanding of and sensitivity for Clinical Research Fraud and Misconduct from a former award-winning FDA Investigator and current Research Auditor that has conducted 100s of audits and developed many fraud and misconduct cases. Elements include definitions, famous cases, how to handle, causes, detection, prevention and who is involved for Pharmaceutical, Device and Biologic Research Sponsors, CROs, IRBs and Investigators.
1 1/2 hours of Education for the entire Research Community including Monitors, Auditors, Coordinators, and Investigators.
1.5 Contact Hours or 0.2 CEUs
$75.00
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NT24: Legal Training for Determining Qualifications of Clinical Investigators
This program provides the Monitor, Coordinator, Investigator, Study Team, Auditors, Review Board Members, and other research professionals with the legal understanding of the requirements and agreements between the FDA, Sponsor/CRO, IRB and Clinical Investigator for determining the Investigator's necessary qualifications for receiving investigational drugs and conducting clinical research. This program examines 21 Title CFR (United States Code of Federal Regulations) 312 and other parts, FDA's Compliance Policy Program 7348.811 on Clinical Investigators, and International Conference on Harmonisation as related to determining investigator's qualifications to receive and treat with investigational drugs.
1 1/2 hours of Education for the entire Research Community including Investigators, Monitors, Auditors, Coordinators, and IRB Members.
1.5 Contact Hours or 0.2 CEUs
$95.00 | |
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NT23: Introduction to Clinical Research Monitoring
Explains the purpose and objectives of monitoring clinical trials including the requirements established by regulations and federal law. Students will learn the history of clinical investigations, the drug development process and the reasons for the need for close oversight by the Monitor of research trials.
2 1/2 hours of Education for the Clinical Research Monitor/CRA.
2.5 Contact Hours or 0.3 CEUs
$75.00 | |
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NT25: Norton Method: Auditing Skills for Monitors
Eliminate the Monitoring technique of simply 'Inventorying' Research Data and Documents by learning Auditing Skills for Monitors. This course provides skills for looking at the global picture of research data and how we must be able to demonstrate reconstruction of research events. All research data must have integrity and the Monitor will learn here how Macro and Micro Skills are utilized to see the broader picture of identifying noncompliance and securing compliance. The Overall Objective of this course is to teach you specific Data Analysis Techniques for looking at the global picture of compliance and non-compliance through an extensive amount of Actual Research Data Case Studies.
3 hours of Education for Monitors, Auditors, and Project Managers or the Investigator or Coordinator looking to advance their Research Skills.
3.0 Contact Hours or 0.3 CEUs
$250.00 | |
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NT21: Conducting A Clinical Investigator Qualification Visit
This course will increase the skills for identifying compliance concerns ‘upfront’ in the monitoring process to prevent noncompliance issues that can impact clinical objectives later, thus decreasing the incidents of selecting inappropriate Clinical Investigators for research. This course also provides tools to Investigators for assessing their readiness for research. Monitors have to be taught skills for understanding how to inspect an Investigator’s facility as well as how to increase their interviewing skills. The program is taught by Tamera Norton Smith, Ph.D., former award-winning FDA Investigator and current trainer of the FDA and the Research Industry on whole.
3 hours of Education for the Clinical Research Monitor/CRA, Auditor, Investigator, and Coordinator.
3 Contact Hours or 0.3 CEUs
$125.00 | |
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NT02: Free Learner Demonstration
See the Effectiveness and Ease of Use of our Instructor-Narrated Graphical Text, Hands-On Digital Library, Instructor Chat, Glossary, FAQ, Quizzes, Training Certificate and Personal Notes Section. Included is a presentation on the Six Primary Quality System Controls necessary for a Clinical Investigator. Please turn down your pop-up blocker and cookie control for proper display.
5 minutes in length
Free | |
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NT01: Free Clinical Operations GCP and ICH Training Series: Corrective and Preventative Actions Procedures
Corrective and Preventative Actions or CAPA, is a means of achieving the FDA's Policy of Voluntary Compliance. By implementing a CAPA Program you are demonstrating your commitment to Compliance and Continuous Improvement. No process is perfect and noncompliance may occur, but you must address this noncompliance through a CAPA process. Learn the full elements of CAPA, as well as reference to our Norton Audits-Specific CAPA Standard Operating Procedure. Our CAPA Moto; Assess to Measure, Measure to Correct, Correct to Prevent, Prevent to Achieve
Approximately 35 Minutes of Education for all Clinical Research Professionals
No Contact Hours or CEUs issued with this course
Free One-Day Access | |
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Course Catalog
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