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
Group Pricing Structure:
$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 email@example.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.
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
- Investigator Selection Guidelines
- Qualifications and Agreements
- Adequate Resources
- Medical Care of Trial Subjects
Module 2: Protocol and GCP Compliance
- Comply with Protocol
- 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
- Special Considerations
- Illiterate Subject
- Pediatric/Cognitively Impaired Subjects
- Emergency Research
Module 4: Investigational Product Management
- Investigator Responsibilities
- Handling and Storage
Module 5: Adequate and Accurate Records
- Essential Document Definition
- Essential Documents
- Before the Clinical Trial
- During the Clinical Trial
- After the Clinical Trial
- Investigator Records Retention Requirements
- Good Documentation
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.