Recommended ACRP eLearning Modules

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Recommended ACRP eLearning Modules
Recommended ACRP
Module
Review
UC Davis CRC 2.0 Module
Ethics and Human Subject
Protection
Covers history, fraud and misconduct,
ethical tension, unethical behavior
Form 1572
Interactive portion and a quiz
Lots of helpful information even for
experienced CRCs
Entertaining game format. Excellent
overview of GCP and ICH.
Progressively harder series of quizzes. Test
your knowledge of relevant ICH Guidelines
(E2 Safety Management, E6 GCP, E8
General Considerations, and E9 Statistics)
Provides a comparison of risk-based
monitoring with the traditional approach,
the impact on CRC data management
activities and implications to sites.
Advanced course reviewing proactive
approaches to site quality management
based on the adult learning theory. Dense
informational content
Based on ICH E8, provides considerations
for drug development plan/process and
individual clinical studies. Includes
contextual scenarios
Discusses levels of inspections, responses
to inspection findings, GCP compliance with
inspections
Implementing IRB regulations
(submissions, reporting,
deviations, AE/SAE)
Implementing IRB regulations
(submissions, reporting,
deviations, AE/SAE)
Introduction to GCP
GCP Test Out Challenge
ICH Gap Analysis Tool
Risk-Based Monitoring: The
essentials for CRCs
Site Quality Management
Tools: SOPs, Metrics and
Training
The Drug Development
Process: Improving Trial
Feasibility and Exploring
Your Growth Potential
Inspection Readiness: Best
Practices for Managing
Clinical Trial Inspections
Managing Billing
Compliance Risks:
Navigating Medicare in
Clinical Trials
Interactive through quizzes and a “dialog”
between a CRC and a Medicare expert.
Excellent overview of Medicare Coverage,
qualification of trials, claims and
compliance risk
Mastering Budgeting at Your Explains concepts, details and example for
Site: Building and
budget preparation and negotiation.
Negotiating Clinical Trial
Feasibility assessment forms. Explains
Budgets That Make Sense
hidden costs, hospital and clinic charges.
Provides negotiation tips
Introduction to GCP
Quality of Data and
Documentation (monitoring,
FDA readiness, study
management)
Quality of Data and
Documentation (monitoring,
FDA readiness, study
management)
Study Feasibility and Start up
Quality of Data and
Documentation (monitoring,
FDA readiness, study
management)
Companion to the CTSC
eModule: Orientation to
Clinical Research Billing (LMS#
09155)
Budgets for Industry Studies
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