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UPCOMING LIVE SEMINARS
 
Auditing Techniques for Clinical Research Professionals
October 23-24, 2014
San Francisco, CA
Monitoring Clinical Drug Studies: Advanced
November 13-14, 2014
San Francisco, CA






Good Clinical Practice for Clinical Trials Online Refresher Course - $199.00


On-Demand Refresher Training for Sponsors and CROs

Barnett’s on-demand GCP refresher training  focuses on the ICH Guideline for Good Clinical Practice, as it is the internationally recognized foundation for the conduct of clinical trials. Designed for those working in sponsor companies and CROs, Barnett’s content is based on a series of “challenge” scenarios, including real-life situations that are encountered at clinical research sites. As participants move through the scenarios,  comprehensive core content, including ICH references, is available for detailed self-study. The course also  includes an application-based post exam that covers the core content contained in the course.  Participant scores are provided at the end of the course, and once successfully completed, participants are eligible to print a Barnett certificate which documents their completion of the 90 minute training module. Formal CEU certificates can also be obtained, if desired.

View Course Demo Here 

On-Demand GCP Refresher Training Demo 

Group Pricing Structure: 

 

1-10 Users
11-20 Users
21-30 Users
31-40 Users
41-50 Users
 

$199 per user
$179 per user
$169 per user
$159 per user
$149 per user
 

 

For more information please contact Naila Ganatra at 215-413-2471 or nganatra@barnettinternational.com  


Course Learning Objectives:
 

  • Practice the application of GCP principles to real-world clinical research situations through the use of warning letters, scenarios, and simulations.
  • Ensure participants are consistently trained on International Conference on Harmonisation Good Clinical Practice (ICH GCP) to achieve:
    • Consistent global interpretation of GCP
    • Increased focus on patient safety and
    • Consistent delivery of quality data
     
 

Course Introduction: 

Why is understanding and applying GCP important? This introductory content is designed to immediately engage the learner in understanding why the course is important, while requiring participation and interaction on the part of the learner.

Introductory Content includes:  

  • Explain the consequences of non-compliance
  • Avoid the most common Global Inspection Deficiencies (includes top 5 inspection findings for Sponsors/CROs and Clinical Investigators)
 

Module 1:  GCP ReferencesEthical Principles – Declaration of Helsinki, Nuremberg, Belmont Report, etc.

ICH Guidelines – emphasis on E6

  • History and Rationale
  • Highlights of 13 GCP Principles [ICH E6 Section 2]
 

Other country-specific GCP standards

  • US Code of Federal Regulations, Title 21
  • EU Clinical Trials Directive 2001/20/EU
 

Module 2:  The Clinical Trial Protocol 

SIMULATION EXERCISE: Protocol Template Review
Core Content: Definitions and Required Elements [ICH E6 Section 6]

Module 3:  Selecting Investigators 

SCENARIO EXERCISE: Determining if an Investigator is Appropriate
Core Content: Qualifications and Responsibilities [ICH E6 Sections 4 and 5.6]

Module 4:  IRB/IEC Review and Approvals 

SIMULATION EXERCISE: IP Documentation Review and Approval
Core Content: Responsibilities, Composition, Function, and Operations [ICH E6 Sections 3, 4.4, and 5.11]

Module 5:  Managing Investigational Product 

SCENARIO EXERCISE: Warning Letter-Based Dispensing/Dosing Error Analysis
Core Content: Investigator’s Brochure - Key Sections and Updates [ICH E6 Section 7]
SCENARIO EXERCISE - “Physician Calls re: AE – Is It Expected?”
Core Content: Investigational Product Accountability [ICH E6 Sections 4.6, 4.7, 5.12-5.14]

Module 6:  Recruiting and Enrolling Subjects 

SCENARIO EXERCISE: Patient Enrollment Scenario
Core Content: Vulnerable populations [ICH E6 Section 4.8.9]
SIMULATION EXERCISE: Patient Recruitment Advertisement Review
Core Content: Advertisement and Compensation Guidelines [ICH E6 Section 3.1]
SCENARIO EXERCISE: Patient Enrollment Decision-Making
Core Content: Informed Consent [ICH E6 Section 4.8]

Module 7:  Managing Clinical Trial Conduct 

WARNING LETTER REVIEW EXERCISE:  Oversight of CRO Scenario
Core Content: Sponsor Responsibilities [ICH E6 Section 5]

Module 8:  Clinical Trial Documentation 

SIMULATION EXERCISE: Sponsor Documentation Example and Problem-Solving

Core Content:

  • Records Retention [ICH E6 Sections 4.9.5, 5.5.7, 5.5.8, 5.5.11, and 5.5.12]
  • Required Documents in Different Study Phases [ICH E6 section 8.0]
 

Module 9:  Monitoring and Managing Sites 

SCENARIO EXERCISE: Investigator Oversight and Protocol Deviations Challenge
Core Content: Monitor qualifications, planning, and documentation [ICH E6 Section 5.18]

Module 10:  Managing Safety Events in a Clinical Trial 

SCENARIO EXERCISE: Determine if a Medical Event is an SAE

Core Content:

  • IND Safety Reports [ICH E6 Sections 5.16 and 5.17]
  • Adverse event and SAEs – Collection, Documentation, and Reporting [ICH E6 Sections 3.3.8 and 4.11]
 

Module 11:  Managing Clinical Trial Data [ICH E6 Section 5.5] 

SIMULATION EXERCISE:  Case History Review Challenge
Core Content: Good Documentation Practices (ALCOA)
SCENARIO EXERCISE:  EDC Compliance Analysis
Core Content: Data Collection and Review

Module 12:  Compliance: Audits and Inspections 

SCENARIO EXERCISE:  Investigator Delegation Challenge

Core Content:

  • Regulatory Authority Inspections [ICH E6 Sections 3.4, 4.1.4, and 5.1.2]
  • Quality Assurance Audits [ICH E6 Section 5.19]
  • Managing Investigator Non-Compliance [ICH E6 Section 5.20]

Course Post-Exam and Certification 


TransCelerate This ICH E6 GCP Investigator Site Training meets the Minimum Criteria for ICH GCP Investigator Site Personnel Training identified by TransCelerate BioPharma as necessary to enable mutual recognition of GCP training among trial sponsors.