Overview
Routine monitoring visits are essential for maintaining trial quality, ensuring participant safety, and verifying regulatory compliance throughout the study. This checklist provides a systematic framework for Clinical Research Associates to conduct thorough, consistent monitoring visits that meet ICH GCP requirements and sponsor expectations.
Before the visit, review previous monitoring reports, any outstanding action items, and recent subject enrollment and data entry status. Use this checklist during the visit to ensure all critical areas are addressed, and document findings in your monitoring report.
Pre-Visit Preparation
- Previous monitoring visit report reviewed
- Outstanding action items from previous visits identified
- Current enrollment status and visit schedule reviewed
- Recent data queries and resolution status reviewed
- Safety reports and SAE status reviewed
- Correspondence since last visit reviewed
- Visit agenda prepared and shared with site
- Site contacts confirmed and meeting scheduled
- Access to EDC and other trial systems verified
- Required documents and forms prepared
Regulatory Document Review
- Site regulatory binder organization reviewed
- IRB/IEC approval current and on file (including amendments)
- Protocol signature page current version signed by PI
- FDA Form 1572 current and accurate (US sites)
- Investigator and sub-investigator CVs current
- Medical licenses current for all listed investigators
- GCP training certificates current for all staff
- Protocol-specific training documentation complete
- Delegation of Authority Log current and appropriately completed
- Signature and Initials Log complete and current
- Financial disclosure forms on file and current
- Laboratory certifications and normal ranges current
- Equipment calibration and maintenance logs current
- All protocol amendments filed with IRB approval documentation
- IB updates filed with acknowledgment documentation
- Serious adverse event reports filed with required documentation
- Subject screening and enrollment log current
- Subject identification log accurate and complete
Informed Consent Review
- Current IRB-approved ICF version in use
- ICF version control log maintained accurately
- Consent process documentation adequate for all subjects
- All required signatures and dates present and correct
- Consent obtained prior to any study procedures
- Re-consent documentation complete for protocol amendments
- Consent by legally authorized representatives documented appropriately
- Assent documentation present where required
- Subject questions and comprehension documented
- Copies provided to subjects as documented
- HIPAA authorization forms complete (US sites)
Source Document Verification
- Source documents identified for selected subjects
- Eligibility criteria verified against source documents
- Visit dates verified against source and CRF
- Adverse events verified against source documentation
- Concomitant medications verified against source
- Medical history verified against source
- Physical examination findings verified
- Vital signs data verified against source
- Laboratory data verified against source and reports
- Protocol deviation identification confirmed
- Efficacy endpoints verified against source (as applicable)
- Subject diary data reviewed and verified (if applicable)
- Query resolution verified against source documents
CRF/EDC Data Review
- Data entry current and timely
- Outstanding queries reviewed and addressed with site
- Query resolution quality and timeliness assessed
- Missing pages or data identified
- Inconsistencies between CRF pages identified
- Correction procedures followed appropriately
- Edit checks and validation rules functioning
- ePRO/eCOA data completeness verified (if applicable)
Investigational Product Accountability
- IP receipt documentation complete and accurate
- IP storage conditions verified and within range
- Temperature logs reviewed and no excursions
- IP inventory accurate and reconciled
- IP dispensing records complete and accurate
- Subject compliance assessed and documented
- Returned IP properly documented
- IP destruction records complete (if applicable)
- Expired or damaged IP handled appropriately
- IP accountability log current and accurate
- Randomization/IWRS logs reviewed and reconciled
Safety Reporting Review
- All AEs properly documented in source and CRF
- AE severity and relationship assessments complete
- SAE reporting timelines met
- SAE follow-up information provided as required
- Safety reporting procedures followed correctly
- Medical monitor notifications documented (if applicable)
- IRB/IEC safety reporting requirements met
- Sponsor safety reports filed at site
- Subject safety follow-up adequate
Laboratory and Specimen Management
- Lab requisitions completed correctly
- Specimen collection procedures followed
- Specimen labeling accurate
- Specimen storage conditions appropriate
- Specimen shipping documentation complete
- Central lab results received and reviewed
- Out-of-range values followed up appropriately
- Local lab values documented as required
Site Operations Assessment
- Staff availability and workload appropriate
- New staff identified and training verified
- Staff delegation appropriate for qualifications
- Communication with sponsor adequate
- Recruitment status reviewed and on track
- Retention strategies in place and effective
- Protocol deviation trends assessed
- Corrective actions from previous visits implemented
- Site questions and concerns addressed
Visit Closeout Activities
- Action items discussed and agreed with site
- Timelines for action item resolution established
- Monitoring visit follow-up letter requirements discussed
- Next visit date tentatively scheduled
- Site staff thanked and any immediate concerns addressed
- Monitoring visit report completed within required timeframe
Visit Summary
Subjects Reviewed: _________________
Key Findings: Document significant findings requiring follow-up
Action Items Generated: _________________
Overall Site Assessment: _________________
Monitor: _________________ Date: _________________
