Seven Monitoring Tips for Interim Monitoring Visits

Introduction

• Addressed to clinical research professionals (CRAs) preparing for on-site visits.
• Focus on interim monitoring visits, which occur between Site Initiation Visit (SIV) and Closeout Visit.
• Encouragement for community interaction through comments.

Tip 1: Confirm Visit with Site Staff

• Coordinate and confirm dates with site staff via email.
• Use warm, friendly communication; remember you are part of a team.
• Offer multiple date options, preferably Monday-Wednesday.
• Lock in the agreed date by sending a calendar invite to all relevant parties (PI, study coordinator, manager, study lead).

Tip 2: Arrange Travel Logistics

• Schedule flight, hotel, and rental car in advance.
• Prefer staying close to the hospital/site to avoid morning traffic.
• Explore the city the day before; prefer leaving the city right after the visit.
• Plan site visits for 8-9 AM and aim to leave by 1-2 PM.
• Prep thoroughly the night before for a swift visit.

Tip 3: Review Monitoring Plan

• Re-read the monitoring plan before each visit.
• Highlight important sections relevant to the visit.
• Create a personalized checklist even if the company provides one.
• Ensure all necessary documents are easily accessible offline.

Tip 4: Review Previous Reports

• Conduct thorough reviews of the previous monitoring reports.
• Treat site as new regardless of previous monitor's proficiency.
• Prepare specific questions based on prior reports for site staff.

Tip 5: Run and Review Reports

• Run safety, training, EDC, query, drug, and TMF site-level inventory reports.
• Conduct an in-depth review to identify any outstanding items.
• Offer site staff tips for improving recurring issues.

Tip 6: Start Trip Report on Site

• Begin the visit report while on site to ensure accuracy.
• Copy and paste unchanged sections from previous reports to save time.
• Avoid starting the report too early to prevent complications from schedule changes.

Tip 7: Answer Questions in Real Time

• Complete report questions during the visit to retain accuracy and detail.
• Prevent memory lapses by documenting observations immediately.

Conclusion

• Engagement: Encourage sharing of additional tips and community learning.
• Future Content: Plans for creating videos on entering clinical research, particularly for coordinators or newcomers.
• Encouragement to like, comment, and subscribe for more content.