Pre-Departure Clinical Review

□ Review participant’s complete medical record
□ Check recent adverse events or SAEs
□ Verify current medications and doses
□ Review last visit’s findings and issues
□ Consult with medical monitor if needed
□ Prepare participant-specific questions
□ Review any new safety alerts
□ Check for protocol updates

Clinical Equipment Verification

□ Blood pressure cuff (multiple sizes)
□ Digital thermometer with covers
□ Pulse oximeter with new batteries
□ Stethoscope (cleaned and functioning)
□ Penlight for assessments
□ Measuring tape for wound/edema
□ Weight scale (calibrated)
□ Emergency medical supplies

Medication Assessment & Management

□ Review study drug accountability
□ Count remaining medication
□ Check storage conditions at home
□ Assess compliance/adherence
□ Review administration technique
□ Check for side effects
□ Document concomitant medications
□ Provide medication education

Comprehensive Health Assessment

□ Obtain complete vital signs
□ Perform targeted physical exam
□ Assess cardiovascular status
□ Check respiratory function
□ Evaluate neurological status
□ Examine skin integrity
□ Assess pain levels
□ Review systems comprehensively

Laboratory Specimen Procedures

□ Verify fasting requirements met
□ Confirm participant hydration status
□ Use proper venipuncture technique
□ Collect specimens in correct order
□ Label immediately at bedside
□ Store at appropriate temperature
□ Document collection details
□ Arrange laboratory transport

Adverse Event Assessment

□ Review any new symptoms
□ Assess severity and relationship
□ Document onset and duration
□ Evaluate need for medical care
□ Determine if SAE criteria met
□ Complete AE forms thoroughly
□ Report SAEs within timeline
□ Provide symptom management

Participant Education Topics

□ Review study procedures
□ Reinforce medication instructions
□ Discuss warning signs to report
□ Provide dietary guidance if needed
□ Review activity restrictions
□ Educate on symptom management
□ Confirm emergency procedures
□ Answer all questions thoroughly

Home Environment Assessment

□ Evaluate medication storage area
□ Check for safety hazards
□ Assess fall risk factors
□ Review emergency access
□ Verify refrigeration if needed
□ Check lighting adequacy
□ Evaluate workspace for procedures
□ Document environmental concerns

Clinical Documentation Requirements

□ Complete all CRFs accurately
□ Document vital signs immediately
□ Record physical exam findings
□ Note any protocol deviations
□ Complete medication logs
□ Document participant education
□ Sign and date all entries
□ Ensure source documentation

Emergency Preparedness

□ Know participant’s emergency plan
□ Have MD contact readily available
□ Carry emergency medications
□ Know route to nearest hospital
□ Have CPR certification current
□ Bring emergency contact list
□ Test communication device
□ Review emergency procedures

Quality Clinical Care

□ Maintain sterile technique
□ Follow universal precautions
□ Ensure participant comfort
□ Protect participant privacy
□ Use therapeutic communication
□ Demonstrate cultural sensitivity
□ Maintain professional boundaries
□ Advocate for participant needs

Post-Visit Clinical Follow-up

□ Review findings with study team
□ Report critical values immediately
□ Update medical monitor on concerns
□ Schedule follow-up if needed
□ Send specimens to laboratory
□ Complete clinical notes
□ Update participant’s care plan
□ Document in regulatory binder