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