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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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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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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
Cost: $175.00
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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
Cost: $175.00
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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-Visits, and everything in-between.
To date, 150 students have successfully completed our CRA Program since 2007.
Twenty (20) Training Modules or 40 hours for New or Experienced Monitors
$800.00
Pay as You Go Programs Available
Cost: $800.00
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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
Cost: $125.00
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NT22: Essential Regulatory Documents
A thorough review of Clinical Investigations documents and forms to comply with GCP and ICH requirements.
1 1/2 hours of Education for the entire Research Community including Investigators, Monitors, Auditors, Coordinators, Quality Assurance and IRB Members.
1.5 Contact Hours or 0.2 CEUs
$95.00
Cost: $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
Cost: $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
Cost: $95.00
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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
Cost: $250.00
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NT26: Reporting of Pre-Marketing Adverse Events
(click on link above for more course information)
The program covers the Reporting of Pre-Marketing Adverse Events (and Effects) detailing FDA and ICH requirements and guidances. The role of the monitor, coordinator and investigator is to ensure adverse events and experiences are reported promptly and appropriately. All products, pharmaceutics and medical devices, have known and unknown risks. The benefits over the risks have to be continually monitored during the investigational development stage. The proper reporting of adverse events can directly impact continuation of the IND and IDE as well as ultimate approval of the product. The student will complete a direct application test (available in the Digital Library) as they complete the audio program portion.
1.5 hours of Education for the Clinical Research Monitor, Coordinator, Investigator and Research Professional.
1.5 Contact Hours or 0.2 CEUs
$125.00
Cost: $125.00
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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
Cost: $75.00
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NT50: Clinical Investigator and Coordinator Operations GCP and ICH Training Series
Individual GCP and ICH Training Modules of Clinical Investigator Systems for the Entry-Level or Current Clinical Research Professional, Investigator and/or Coordinator. Purchase individually (Courses NT51 - NT62) or the entire Series (NT50). Each module provides a detailed description of the legal and regulatory requirements defined by Good Clinical Pratices for Clinical Investigator Research. A GCP and ICH training certificate is provided for each module completed.
To date, over 250 students have completed this Clinical Operations Program since 2008.
12 Training Modules Covering 8 Hours of Training
$275.00
Cost: $275.00
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NT51: Clinical Operations Introduction to Standard Operating Procedures
The Who, What, Why, When, and How of your SOPs.
Defining The "Product" of your Clinical Research.
Learn the importance of Managing Your Regulatory Risk.
You should take this module before taking any of the SOP-specific training modules.
20 Minutes of Education for the Clinical Research Investigator, Coordinator, Monitor/CRA, and Auditor.
CEUs Not Available, Training Certificate Included
$20.00
Cost: $20.00
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NT55: Clinical Operations GCP and ICH Training Series: Completion of Form FDA 1572
Form FDA 1572, Statement of Investigator, is a vital document completed by the Clinical Investigator Team at the beginning of a pharmaceutical research trial. Several key implications and commitments are made on this Form, which are detailed in this training along with formal instructions for how to prepare this Form properly.
20 Minutes of Education for the Clinical Research Investigator, Coordinator, Monitor/CRA, and Auditor.
CEUs Not Available, Training Certificate Included
$15.00
Cost: $15.00
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NT57: 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 25 Minutes of Education for all Clinical Research Professionals
No Contact Hours or CEUs issued with this course
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NT58: Clinical Operations GCP and ICH Training Series: Documenting Delegation of Authority
Delegation of Authority is a general theme throughout the Investigator regulations, which must not be taken lightly. It is a privilege to receive investigational products, but an Investigator may not delegate their general responsibility, but they can delegate specific tasks. Learn the key do's and don'ts of the Delegation of Authority process.
30 Minutes of Education for the Clinical Research Investigator, Coordinator, Monitor/CRA, and Auditor.
CEUs Not Available, Training Certificate Included
$25.00
Cost: $25.00
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NT60: Clinical Operations GCP and ICH Training Series: Monitoring Close-Out Visits
The legal and regulatory necessity of the Monitoring Close-Out or Termination Visit Process are reviewed along with the requirements for the Investigator Study Team in this training module. At this point, subjects have been treated with the test article, new information has been gained, and all research data has been submitted to the Sponsor or CRO. This training module includes discussion on the requirements, process, and conduct of a Monitoring Close-Out Visit.
20 Minutes of Education for the Clinical Research Investigator, Coordinator, Monitor/CRA, and Auditor.
CEUs Not Available, Training Certificate Included
$15.00
Cost: $15.00
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NT62: Clinical Operations GCP and ICH Training Series: Study Team Training
Training is necessary to meet the federal regulation and medical ethics requirements for education, training, experience, and medical qualifications for conducting clinical research. This module will focus on why and how these regulations require training and how to provide this training.
25 Minutes of Education for the Clinical Research Investigator, Coordinator, Monitor/CRA, and Auditor.
Cost: $20.00
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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
Cost: $250.00
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