Date
New Clinical Project Manager (CPM) or Clinical Research Associates (CRA)
Orientation - Training
Step 1 - GETTING TO KNOW XXXXX
Corporate Orientation – (person conducting)
▪ Sponsor Origins, Mission, Culture
▪ Provision of an Sponsor Org Chart
▪ HR –Benefits,
▪ Travel policy, Expenses
▪ Virtual/Physical walk around if in office start
Information Technology (IT) Training – (person conducting)
▪ File access, email setup ,
▪ Remote access (how to log into the system when you're on the road, replication,
troubleshooting)
▪ Meeting set-up
▪ Instant messaging system
Introduction to Sponsor Quality System (1 hour) – (person conducting)
▪ Quality Policy
▪ Training Matrix
▪ Required Training
▪ SharePoint access – SOPs, controlled forms, Qualified Vendors list
Introduction to the Clinical Research Department – (person conducting)
▪ Overview of organizational chart and reporting structures
▪ Buddy System
▪ Clinical Operations
▪ Clinical Medical/Science/PVG
▪ Data Management
▪ Medical Writing
▪ Department Milestones and Corporate Objectives
▪ Clinical Systems access (clinical folders, DocuSign, EDC, TMF)
Step 2 – CLINICAL TRAINING
Clinical Operations Systems/Connections – (person conducting)
▪ Budgets and Contracting
▪ Clinical filing system and study files
Current Investigational Products (~1.5 hrs.)- (CMO)
▪ Development of the drug (s)
▪ Pharmacology of the drug (s)
▪ Therapeutic use and administration
▪ Review of the Clinical Investigator's Brochure
Step 3 - STUDY/PROJECT SPECIFICS
Assigned Study Specifics - CPM or designee
▪ Study History and current status
▪ Study Team
▪ Regulatory Status
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Vendors
Timelines, Milestones, Budget, Invoicing
SIV slide review
FAQs
Protocol, IB, ICF
▪ Amendment history (if applicable)
Management / Monitoring Processes, Practices and Guidelines as appropriate
▪ Clinical Monitoring/Remote monitoring
▪ Reporting requirements
▪ Source verification (degree of verification)
▪ Study tools and forms
▪ Monitoring tools
▪ Preparing a site visit (PSV, SIV, IMV, COV)
Introduction to EDC Monitoring Processes – (person conducting)
▪ eCRF Completion Guidelines
▪ Reviewing and verifying Data
▪ Data queries at site/Edit checks
▪ Process maps
▪ Reports
Safety Reporting – (CMO)
▪ Adverse event reporting
▪ SAE reporting Process
Clinical Operations Process Flow
▪ eTMF/eISF
▪ Clinical Trial Agreements/Budget/Invoice process- review, approval, signoff
▪ Protocol Amendments and Approvals
Step 4 – SITE INTERACTIONS
Site management
▪ Communications and correspondence (emails/phone calls)
▪ Standards of conduct and behaviour
CPM Co-monitoring Visits for CRAs (expected duration - min. 2 visits)
▪ Preparing for the visit
▪ Conducting the visit
▪ Visit Report
▪ Follow-up
Step 5 - ADVANCED TRAINING
To be completed as necessary or if relevant:
Remote and Secondary Monitoring Activities
Database Close Activities
▪ Data listings review
▪ Data Clarification Requests
Conducting Trend Analyses
▪ Safety trending
▪ Protocol Deviations Review
▪ Fraud and misconduct
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