Clinical Research Monitoring/ Quality

Penn Clinical Research Monitoring Onboarding

Training Resource: Monitoring Onboarding Training 

Frequency: Before starting monitoring/ quality responsibilities 

Applies to anyone who is: Designated by his or her department to serve in a monitoring, quality role that requires use of PennVault/ SiteVault training i.e. managing site files or electronic regulatory binders in PennVault  

This recommended program for clinical research monitors includes:  Clinical Trial Monitoring Basics , Building Quality Management Systems for Sites and Sponsors , FDA Form 1572 , eResearch Managing Clinical Trials in an Electronic Environment. In addition, we recommend departmental shadowing 

Tools and Templates to support monitoring tasks:

• Monitoring visit report consists of two documents (coming soon):

  • Monitoring Findings

  • Monitoring Visit Summary

• Data Safety Monitoring Plan (DSMP) 

• Monitoring Log  (coming soon)

• Monitoring analysis  

• Close out visit checklist- investigator   (coming soon)