Protocol Training Module

□ Read entire protocol thoroughly
□ Attend protocol training session
□ Review protocol synopsis
□ Understand inclusion/exclusion criteria
□ Learn visit schedule and procedures
□ Review primary and secondary endpoints
□ Understand safety monitoring plan
□ Complete protocol knowledge assessment
□ Training Date: ____________
□ Trainer: ____________
□ Score: ____________

Good Clinical Practice (GCP)

□ Complete GCP certification course
□ Review ICH-GCP guidelines
□ Understand FDA regulations (21 CFR)
□ Learn about research ethics
□ Review informed consent process
□ Understand participant rights
□ Learn documentation standards
□ Pass GCP examination
□ Certificate Date: ____________
□ Expiration: ____________

Regulatory Training

□ Review IRB/EC requirements
□ Understand consent form process
□ Learn about protocol deviations
□ Review adverse event reporting
□ Understand privacy regulations (HIPAA)
□ Learn document retention requirements
□ Review audit preparation
□ Complete regulatory quiz
□ Completion Date: ____________

Safety Training

□ Review safety monitoring plan
□ Learn SAE identification and reporting
□ Understand AE grading scales
□ Practice safety event documentation
□ Review emergency procedures
□ Learn unblinding procedures (if applicable)
□ Understand SUSAR reporting
□ Complete safety assessment
□ Training Hours: ____________

System Training

□ Complete EDC system training
□ Practice data entry scenarios
□ Learn query resolution process
□ Understand CTMS navigation
□ Review document management system
□ Learn randomization system (IWRS/IXRS)
□ Practice drug accountability system
□ Obtain system access credentials
□ Systems Trained: ____________

Laboratory Training

□ Review lab manual
□ Learn specimen collection procedures
□ Understand processing requirements
□ Review shipping procedures
□ Practice labeling requirements
□ Learn centrifuge operation
□ Understand temperature requirements
□ Complete lab competency assessment
□ Lab Certification: ____________

Study Procedures Training

□ Practice informed consent discussion
□ Learn screening procedures
□ Review enrollment process
□ Practice visit procedures
□ Learn physical exam requirements
□ Review questionnaire administration
□ Practice device operation
□ Demonstrate procedure competency
□ Procedures Mastered: ____________

Documentation Training

□ Learn source documentation standards
□ Practice ALCOA-C principles
□ Review note-to-file procedures
□ Understand correction procedures
□ Learn filing system
□ Practice CRF completion
□ Review query response process
□ Complete documentation exercise
□ Exercise Score: ____________

Drug/Device Training

□ Review investigational product handling
□ Learn storage requirements
□ Understand dispensing procedures
□ Practice accountability documentation
□ Review administration techniques
□ Learn about side effects
□ Understand return/destruction process
□ Complete IP handling assessment
□ Assessment Date: ____________

Site-Specific Training

□ Review site SOPs
□ Tour facility and locate supplies
□ Meet team members
□ Learn emergency procedures
□ Review site-specific forms
□ Understand workflow processes
□ Learn equipment location
□ Complete site orientation checklist
□ Orientation Date: ____________

Communication Training

□ Review communication plan
□ Learn escalation procedures
□ Understand meeting schedules
□ Review email/phone etiquette
□ Learn report timelines
□ Practice participant communication
□ Review team communication tools
□ Complete communication exercise

Financial Training

□ Understand study budget
□ Learn about participant payments
□ Review expense reporting
□ Understand invoicing process
□ Learn about financial compliance
□ Review cost tracking procedures
□ Understand budget limitations
□ Complete financial overview

Monitoring Preparation

□ Understand monitoring visit process
□ Learn about source data verification
□ Review document availability
□ Practice monitor interaction
□ Understand CAPA process
□ Learn follow-up letter response
□ Review metrics and KPIs
□ Complete monitoring readiness check

Competency Assessment

□ Complete written examination
□ Demonstrate practical skills
□ Pass role-specific assessment
□ Receive supervisor sign-off
□ Document training completion
□ File training records
□ Schedule refresher training
□ Receive study delegation
□ Final Score: ____________
□ Delegation Date: ____________