Streamlining Site Monitoring in Clinical Trials - Mickie Speers' Approach

Mickie Speers, a Site Manager/Monitor at SIREN CCC, University of Michigan, shared insights on enhancing quality data production in clinical trials. The approach focuses on ensuring subject safety, providing education and feedback, and fostering collaboration to optimize the ICECAP trial. Topics include monitoring visits, scope of monitoring, pre-visit checklist, PI responsibilities, and streamlining monitoring with remote source data verification.

• Clinical Trials
• Site Monitoring
• Data Quality
• Collaboration
• Remote Verification

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1. Site Monitoring Mickie Speers Investigator Kick-off Meeting January 30-31, Clearwater, Florida

2. ICECAP INFLUENCE OF COOLING DURATION ON EFFICACY IN CARDIAC ARREST PATIENTS Site Monitoring Mickie Speers ICECAP Site Manager/Monitor SIREN CCC, University of Michigan

3. Agenda Goals Site Monitoring Visits Scope of Monitoring Pre-Visit Checklist PI Responsibilities Remote Source Data Verification

4. Goal The monitor s approach to a visit is to ensure subject safety, provide education and good feedback and foster a collaborative spirit to produce the best quality data in the ICECAP trial.

5. Site Monitoring Visits Initial Visit Routine & Interim Monitoring Visits Close-Out Visit

6. Scope of Monitoring Regulatory Study Team changes Facilities Informed Consent CRFs and source document verification

7. Pre-Visit Checklist Organized study files Data entered and reviewed All visits scheduled Coordinator is available eHR access confirmed

8. Principal Investigator Responsibilities Available to the PSC Good team communications Prompt review and signatures Post monitoring meeting

9. Streamlining Monitoring with Remote Source Data Verification (RSDV) To work toward this capability at your site Ask other study coordinators Contact eMR system administrator, HIM, Privacy office Identify a champion to help navigate the process

10. Questions? Mickie Speers 734-232-3474 lraes@med.umich.edu