Pre-Visit Clinical Preparation

□ Review participant’s complete medical history
□ Check recent lab results and vital signs trends
□ Verify current medications and allergies
□ Review study protocol inclusion/exclusion criteria
□ Consult with principal investigator on specific concerns
□ Prepare participant-specific care plan
□ Check for any protocol amendments
□ Review adverse event reporting procedures

Medical Equipment & Supplies

□ Blood pressure monitor (calibrated)
□ Thermometer and probe covers
□ Pulse oximeter
□ Glucometer and test strips (if needed)
□ Stethoscope
□ Weight scale (portable if required)
□ Specimen collection supplies (tubes, labels, bags)
□ Sharps container
□ Medical waste disposal bags

Clinical Documentation Preparation

□ Case report forms (CRFs)
□ Adverse event forms
□ Concomitant medication logs
□ Vital signs recording sheets
□ Lab requisition forms
□ Source documentation templates
□ Protocol deviation forms
□ Participant diary/questionnaires

Medication Management

□ Verify study drug accountability
□ Check medication storage requirements
□ Prepare drug dispensing logs
□ Review medication administration schedule
□ Confirm participant’s adherence tracking
□ Check for drug interactions
□ Prepare education materials on study medication
□ Plan for medication returns/destruction

Safety & Emergency Preparedness

□ Verify emergency contact numbers
□ Locate nearest hospital/emergency services
□ Pack emergency medical supplies
□ Review participant’s emergency action plan
□ Ensure cell phone is fully charged
□ Carry basic first aid kit
□ Review anaphylaxis protocol if applicable
□ Confirm transportation plan for emergencies

Clinical Assessment Procedures

□ Perform comprehensive health assessment
□ Measure and record all vital signs
□ Conduct physical examination per protocol
□ Assess for adverse events or SAEs
□ Review symptom diary with participant
□ Evaluate medication compliance
□ Check injection sites if applicable
□ Perform protocol-specific assessments

Specimen Collection & Handling

□ Verify fasting status if required
□ Label all specimens correctly
□ Follow chain of custody procedures
□ Use appropriate collection techniques
□ Store specimens at correct temperature
□ Complete lab requisition forms
□ Arrange specimen transportation
□ Document collection time and conditions

Participant Education & Support

□ Review study procedures and timeline
□ Educate on medication administration
□ Discuss adverse event reporting
□ Provide symptom management strategies
□ Review diary completion instructions
□ Answer clinical questions
□ Assess participant understanding
□ Provide 24/7 contact information

Regulatory Compliance

□ Ensure GCP compliance throughout visit
□ Maintain participant confidentiality
□ Complete source documentation in real-time
□ Report protocol deviations immediately
□ Document all clinical decisions
□ Ensure informed consent is current
□ Follow institutional review board guidelines
□ Maintain regulatory binder updates

Quality Assurance

□ Double-check all data entries
□ Verify CRF completion
□ Cross-reference source documents
□ Confirm specimen labeling accuracy
□ Review medication accountability
□ Check equipment calibration logs
□ Validate data against protocol requirements
□ Prepare for potential monitoring visits

Post-Visit Clinical Tasks

□ Enter data into EDC system within 24 hours
□ Report any SAEs immediately
□ Update participant’s medical record
□ Coordinate with study team on findings
□ Schedule follow-up as needed
□ Process and ship specimens
□ Complete visit payment documentation
□ File all source documents appropriately