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On-Demand Good Clinical Practice for Investigators - $199.00


Barnetts On-Demand GCP Training for Investigators

Barnett’s On-Demand Good Clinical Practice for Investigators scenario-based eLearning course is designed with the busy Principal Investigator in mind.  Based on real-life scenarios encountered by investigative site teams, this highly focused 7-module GCP training is designed to ensure comprehensive understanding of the key components of GCP. The structure of the course allows clinical research investigators to achieve GCP certification via a multistage approach.  For the more experienced,  a rigorous pre assessment is provided, giving those who are able to score 100% the opportunity to “test-out” of the course. For others, key components of GCP are covered through focused, situation-based problem solving exercises.  The course concludes with a post-assessment challenge, on which an 80% “passing score” must be achieved prior to achieving certification.

 

Course Learning Objectives
Upon completion of this scenario-based course, participants will be able to:

  • Describe Investigator responsibilities in the context of study protocol oversight and GCP compliance.
  • Recognize critical elements of human subject protection.
  • Discuss the requirements for investigational product management and maintenance of adequate and accurate records for research trials.
  • Recognize key requirements for patient safety management and regulatory reporting.
  • Discuss mandatory critical interactions with Institutional Review Boards (IRBs) or Ethics Committees (ECs).

View Course Demo

GCP for Investigators 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 

Pre-Assessment: a 10-question challenge assessment is provided at the beginning of the course. If 100% is scored, participants may proceed to the completion screen and print their certificate. If 100% is not achieved, participants are directed to the start of the course.

Course Outline:

Module 1: Investigator Responsibilities

  • Good Clinical Practice Components
    • Local Regulations and IRB/EC Policies
    • International Conference on Harmonization (ICH GCP)
    • Standard of Care
    • Hospital or Institutional Policies
    • Standard Operating Procedures (SOPs)
    • Government Regulations
  • Ethical Principles
    • ICH GCP E6 and the Belmont Report
  • Principles of ICH GCP
    • 13 Principles of ICH GCP
  • Investigator Selection Guidelines
    • Qualifications and Agreements
    • Adequate Resources
    • Medical Care of Trial Subjects

Module 2: Protocol and GCP Compliance

  • Comply with Protocol
    • Deviation
    • Violation
    • Misconduct
  • Failure to Comply – Possible Consequences
  • Top 10 EMA Categories of Inspection Findings
  • Top 5 FDA Inspection Findings for Various Roles
    • Insight Question: Why do you think the top 5 FDA inspection deficiencies for Investigators have not significantly changed in recent years?
  • Investigator Audits
    • Study-oriented (routine) audits
    • Directed (for cause) audits
    • Division pilot program audits

Module 3: Human Subject Protection

  • Informed Consent
    • Process
    • Language
    • Ethics
  • Special Considerations
    • Illiterate Subject
    • Pediatric/Cognitively Impaired Subjects
    • Emergency Research

Module 4: Investigational Product Management

  • Investigator Responsibilities
    • Return
    • Accountability
    • Handling and Storage
    • Responsibilities

Module 5: Adequate and Accurate Records

  • Essential Document Definition
    • Investigator
    • Sponsor
    • CRO
    • IRB/IEC
  •  Essential Documents
    • Before the Clinical Trial
    • During the Clinical Trial
    • After the Clinical Trial
  • Investigator Records Retention Requirements
  • Good Documentation
    • ALCOA-CCEA principles

Module 6: Patient Safety Management

  • Safety Event Management
    • Responsibilities for both investigators and sponsors in this arena

Module 7: IRB/EC Interactions

  • IRB/EC Review and Approval Process
    • Regulatory inspections often reveal inadequate reporting to these committees or a lack of sufficient EC documentation and records.

Summary: Bottom Line on GCP

  • Good Clinical Practice has its foundation in the International Conference of Harmonization guidelines as a standard for every step and process in the conduct of clinical trials.
    • GCP Compliance
      • Protects safety, rights and well-being of subjects
      • Produces reliable and accurate data and results
      • Develops quality product for patients in need

Post-Assessment: A 10-question post-assessment challenge is provided at the end of the course. A passing score of 80% must be achieved to advance to the completion screen, where a certificate may be printed.  If the assessment is not passed, participants may make two additional attempts to pass the assessment before being returned to the start of the course.

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On-Demand GCP Refresher Training 

Too busy to attend a course? Our newly-released GCP eLearning course may be your solution!
For details on our scenario-based practical GCP application on-demand course, click here.


GCP for Investigators
 

Barnett’s scenario-based eLearning course is designed with the busy Principal Investigator in mind.  Based on real-life scenarios encountered by investigative site teams, this highly focused 7-module GCP training is designed to ensure comprehensive understanding of the key components of GCP.

For more details on this scenario-based eGCP program for investigators please click here. 


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Informed Consent Content & Process Requirements for Biobanking Studies 

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Web SeminarWEB SEMINARS

10-Week CRA & CRC Beginner Program  

Trial Master File (TMF) for Sponsors: Set-Up and Maintenance 

Use of Notes to File in Clinical Trial Essential Documentation 

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PublicationsPUBLICATIONS

2012 GCP Question & Answer Guide Print Edition 

2012 Good Clinical Practice Question & Answer Guide Electronic Edition 

CFR/ICH GCP Reference Guide 2012 (Spiral Bound) 

CFR/ICH GCP Reference Guide 2012 (Perfect Bound) 

PAREXEL's Bio/Pharma R&D Statistical Sourcebook 2012/2013 (Hard Copy)