Study Start Up Training Checklist For Research Staff

Proper research staff training is the foundation of study quality and regulatory compliance. This comprehensive training checklist covers 14 essential modules that transform new coordinators into competent research staff in 2-4 weeks. Includes protocol training, Good Clinical Practice certification, regulatory requirements, safety reporting, system training, laboratory procedures, study procedures, documentation standards, investigational product handling, site-specific orientation, communication protocols, financial procedures, monitoring preparation, and competency assessment. Each module includes learning objectives, assessment criteria, and sign-off requirements. Meets FDA, ICH-GCP, and sponsor requirements for staff qualification and delegation.

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: ____________

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: ____________

How the Study Start Up Training Checklist For Research Staff works

Begin with protocol training by reading the full protocol, attending the training session, and completing a knowledge assessment. Complete online GCP certification through an accredited provider (typically 4-8 hours). Review regulatory requirements including IRB processes, consent procedures, and deviation reporting. Complete safety training on adverse event identification, grading, and reporting timelines. Get hands-on system training for EDC, CTMS, IWRS, and document management platforms. Practice laboratory procedures until you demonstrate competency in specimen collection, processing, and shipping. Master study procedures through supervised practice and competency demonstration. Document training completion dates, scores, and trainer signatures throughout.

Inadequately trained staff cause 60% of protocol deviations and 45% of FDA inspection findings. Each major deviation requires investigation, CAPA plans, and potential regulatory reporting. Training failures cost studies $30,000-150,000 in delays, rework, and quality issues. Proper training reduces deviations by 70% and improves data quality query rates by 50%. FDA requires documented evidence that staff are qualified to perform delegated tasks before they conduct study procedures. This checklist ensures systematic training that meets regulatory requirements. Sites with structured training programs score 40% higher on sponsor audits and experience 65% fewer monitoring findings. You’ll build competent staff who execute studies correctly from day one.

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