Interim Monitoring Visits

1. Interim Monitoring Visit
Week 5
Narrated by Dan Sfera
Refer to Interim Monitor Letters in Intralinks VIA

2. Interim Monitoring Visit
IMV
Also referred to as Routine Monitoring Visit
(RMV)
CRA’s visit their sites every 4-6 weeks on average

3. Different Monitoring Strategies
Traditional Monitoring
Remote Monitoring
Risk Based Monitoring

4. Confirmation Letter
Sent 1-2 weeks before monitoring visit
Date(s) and time of monitoring visit
Outlines what will be reviewed
Existing action items from previous monitoring visit
How long CRA will need to meet with PI

5. Day Of IMV
Arrive on time and meet with study coordinator
Sign into Monitoring Visit Log in reg binder
Review Outstanding Action Items From previous
visit
100% SDV or follow Risk Based Monitoring Plan

6. IP Accountability
Review new activity since previous monitoring visit
Site recruitment plan
Look for protocol deviations
Document any necessary training in training log
Ensure EDC is up to date
Regulatory maintenance

7. Recruitment
Site’s enrollment goal/cap
Site’s current status (screening hold or enrolling)
Screen Fails
Randomized
Early Terminations or Lost to Follow Up

8. Deviations
Protocol deviations
IRB reportable or not
Retraining of study staff must be documented
Corrective action plans
Revision or retraining of Site’s SOP’s?
ICF Issues

9. Data Collection
Ensure source documents contain all data points as per protocol
Ensure subject medical history is obtained
Ensure I/E criteria has been met
Ensure AE’s, SAE’s, Con Meds, and Med history is
documented
Discrepancies between source and EDC need resolution
Ensure PI oversight and GCP adherance

10. Regulatory
Reg binder revisions and new filings need maintenance
Protocol Amendments
IRB Approvals
New study staff
Updated GCP, IATA Certifications
CLIA or CLIA waivers

11. Medical Equipment Calibrations
SOP revisions
SUSARS
Continuing Review Reports
Delegation of Duties Log
Site Training Log

12. New Action Items
Added to any prior outstanding action items
Need to be communicated to the PI
Summarized at end of monitoring visit with SC and PI
Source documentation to meet ALCOA standards
PI oversight (lab results, ecg reports, ae and con meds)
IP accountability

13. Follow Up Letter
Sent 1-2 weeks after IMV
Summarizes the most recent monitoring visit
Action items
Findings
Screening Status
Monitoring Status
Was PI available in person or by phone?
Next tentatively scheduled monitoring visit
Sent to Site and also filed in the TMF