Clinical Research Associate (CRA) Training Monitoring Foundations
What a monitor actually does: site feasibility and qualification, start-up and activation, the regulatory file, monitoring visits and their reports, and oversight of data, documentation and trial supplies. It assumes no prior course and no prior knowledge.
30 lessons, about 167 minutes. Free, in your language.
Foundations for the Monitor
The Protocol as the CRA's Rulebook
Site Identification and Feasibility
Evaluating and Qualifying a Site
Start-Up, Contracts and Activation
Regulatory Documents and the Site File
Monitoring Visits
Monitoring Approaches and Reporting
Site Performance, Recruitment and Compliance
Data, Documentation and Trial Supplies
Free courses Clinical Research in One Lesson GCP, ICH E6(R3) and the Regulators What a CRA Actually Does What Is in a Protocol, and Why The Sections a CRA Lives In Amendments and Version Control Why Site Selection Decides the Trial The Criteria Used to Judge a Site Feasibility Questionnaires and Validating What Sites Claim The Pre-Study Visit Scoring Risk and Recommending a Site Deliverables, Handover and Common Mistakes What a Clinical Trial Agreement Contains The Contract Clauses That Shape Your Monitoring Why Negotiations Stall, and Getting a Site Activated Investigator, Staff and Ethics Documents Sponsor, Pharmacy, Laboratory and Safety Records Collecting, Filing and Staying Inspection-Ready The Types of Monitoring Visit and What Each Is For Preparing for a Monitoring Visit Conducting the Visit: SDV, IP, Documents and the Closing Meeting On-Site and Remote Monitoring Risk-Based Monitoring and Centralized Oversight The Monitoring Visit Report and Follow-Up Overseeing Recruitment and Enrollment Protocol Compliance and the Deviations You Will See Most Classifying, Escalating and Corrective Action The Systems Trial Data Move Through Documentation That Holds Up to Inspection Trial Supplies, IP Accountability and the Supply Chain All clinical research training