Visit Authorization & Compliance

□ Verify IRB approval for home visits
□ Confirm protocol allows home visits
□ Check participant eligibility for home visit
□ Ensure informed consent covers home procedures
□ Verify insurance coverage for off-site visits
□ Document medical necessity if required
□ Obtain supervisor approval
□ Review institutional home visit policy

Pre-Visit Risk Assessment

□ Review participant’s home environment history
□ Assess neighborhood safety factors
□ Check for environmental hazards
□ Evaluate accessibility requirements
□ Consider participant’s medical stability
□ Review emergency response capabilities
□ Assess need for second team member
□ Document risk mitigation strategies

Essential Contact Information

□ Participant’s primary phone number
□ Alternative contact number
□ Emergency contact person and number
□ Principal investigator contact
□ Study coordinator contact
□ Medical monitor number (if applicable)
□ Local emergency services number
□ Nearest hospital information

Core Documentation Package

□ Study protocol (abbreviated version)
□ Informed consent forms
□ Visit-specific CRFs
□ Source document worksheets
□ Adverse event forms
□ Protocol deviation forms
□ Visit completion checklist
□ Reimbursement forms

Standard Operating Procedures

□ Review home visit SOPs
□ Follow specimen collection SOPs
□ Implement safety SOPs
□ Apply infection control procedures
□ Follow equipment maintenance SOPs
□ Implement data security protocols
□ Apply emergency response procedures
□ Follow communication protocols

Medical Supplies Inventory

□ Vital signs equipment
□ Phlebotomy supplies
□ Specimen containers
□ PPE (masks, gloves, gowns)
□ Sanitization supplies
□ Bandages and gauze
□ Alcohol swabs
□ Sharps container

Technology Requirements

□ Laptop/tablet with study database access
□ Mobile phone with full battery
□ Portable scanner/camera for documents
□ GPS device or smartphone navigation
□ Backup paper forms
□ Portable printer (if needed)
□ Secure file storage device
□ Hotspot for internet access

Visit Execution Protocol

□ Arrive within scheduled window
□ Verify participant identity
□ Confirm consent and willingness
□ Set up clean workspace
□ Follow visit procedure sequence
□ Maintain professional boundaries
□ Document start and stop times
□ Complete all required assessments

Data Quality Measures

□ Complete forms in real-time
□ Review for missing data
□ Verify accuracy of entries
□ Cross-check source documents
□ Ensure legible handwriting
□ Use only approved corrections
□ Initial and date all entries
□ Obtain required signatures

Specimen Management

□ Verify specimen requirements
□ Label before collection
□ Follow collection procedures
□ Document collection times
□ Store at proper temperature
□ Arrange timely transport
□ Complete chain of custody
□ Track specimen status

Participant Engagement

□ Maintain professional demeanor
□ Respect participant’s home
□ Address concerns promptly
□ Provide clear instructions
□ Ensure understanding of procedures
□ Thank participant for participation
□ Schedule next visit if applicable
□ Provide study team contact information

Post-Visit Requirements

□ Complete data entry within timeline
□ Submit specimens to lab
□ Report any incidents/AEs
□ File documentation appropriately
□ Clean and restock supplies
□ Update visit tracking log
□ Communicate with study team
□ Prepare for next visit