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 ObjectivesUpon 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.
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.