Checklist Preparing For Clinical Research Visits At Home

Initial Planning Phase (2-4 Weeks Before)

□ Review study protocol thoroughly
□ Identify all visit requirements and procedures
□ Create visit-specific checklist from protocol
□ Coordinate with study team members
□ Review budget and resource allocation
□ Assess staffing needs for visit
□ Plan visit schedule and timeline
□ Identify potential challenges or barriers

Participant Preparation (1-2 Weeks Before)

□ Contact participant to schedule visit
□ Send pre-visit instructions and requirements
□ Confirm participant’s home address and directions
□ Verify participant has necessary space for visit
□ Discuss any special accommodations needed
□ Remind about fasting or other preparations
□ Confirm participant availability for full visit duration
□ Arrange for caregiver presence if required

Regulatory Preparation

□ Ensure current IRB approval
□ Verify informed consent is up-to-date
□ Check for any protocol amendments
□ Review HIPAA and privacy requirements
□ Prepare confidentiality measures
□ Update regulatory binders
□ Confirm insurance and liability coverage
□ Review institutional policies for home visits

Supply Inventory & Organization

□ Create master supply list from protocol
□ Inventory all supplies and equipment
□ Order any missing items
□ Organize supplies by procedure
□ Label all containers and bags
□ Prepare backup supplies
□ Check expiration dates
□ Create supply tracking sheet

Equipment Preparation & Testing

□ Test all electronic equipment
□ Calibrate measurement devices
□ Charge all batteries
□ Prepare backup equipment
□ Clean and sanitize equipment
□ Pack equipment securely
□ Create equipment checklist
□ Prepare troubleshooting guide

Documentation Preparation

□ Print all necessary forms (multiple copies)
□ Prepare electronic data capture access
□ Create source document templates
□ Organize forms by visit procedure
□ Prepare participant handouts
□ Include extra blank forms
□ Waterproof important documents
□ Create documentation tracking log

Team Coordination

□ Assign team member responsibilities
□ Schedule pre-visit team meeting
□ Review visit procedures with team
□ Discuss contingency plans
□ Confirm team member availability
□ Share emergency contact information
□ Plan communication during visit
□ Designate point person for issues

Logistics Planning

□ Plan travel route and alternatives
□ Arrange transportation/parking
□ Check weather forecast
□ Prepare for different scenarios
□ Plan visit timeline with buffers
□ Coordinate specimen pickup/delivery
□ Arrange for interpreter if needed
□ Plan for pet management

Risk Management Planning

□ Conduct risk assessment for home visit
□ Develop safety protocols
□ Create emergency response plan
□ Identify nearest medical facilities
□ Prepare incident report forms
□ Review liability insurance
□ Plan for adverse events
□ Establish check-in procedures

Week of Visit Preparation

□ Confirm visit with participant (48 hours before)
□ Check all equipment functionality
□ Review participant’s recent data
□ Pack all materials systematically
□ Prepare day-of contact list
□ Review weather and traffic
□ Confirm team member readiness
□ Send reminder to participant (24 hours before)

Day Before Visit

□ Final equipment check
□ Charge all devices overnight
□ Pack vehicle with supplies
□ Review protocol one more time
□ Prepare paperwork packet
□ Check emergency supplies
□ Confirm with team members
□ Set multiple alarms

Day of Visit Final Checks

□ Review checklist one final time
□ Confirm participant is ready
□ Check traffic and weather
□ Ensure all supplies are loaded
□ Verify documentation is complete
□ Test communication devices
□ Brief team on day’s plan
□ Conduct final safety check