Fee for Service / OCR Monitoring

Fee For Service Research Cores:  

The following are fee for service cores that can assist researchers with specific aspects of clinical research work. Typically these may be most useful for sponsor investigators and/or those conducting investigator initiated research work.  

OCR Monitoring

The Office of Clinical Research provides fee for service monitoring for clinical research teams. A monitor will be assigned to your study and assist you will the following: 

• Core research document review- protocol, consent, CRFs 

• Create Data Safety Monitoring Plan (DSMP) for your study and detailed monitoring timeline and visit schedule   

• Train staff, along with sponsor team, at Site Initiation Visits  

• Conduct monitoring visits and generate monitoring visit reports  

• Final Study close out visit and assist with database lock 

The Office of Clinical Research has a core set of monitoring documents which can be found in the forms, tools and templates library. All clinical research should have some type of monitoring in place for ongoing quality assurance. The complexity and risk level of the study are some of the factors taken into account when trying to determine an appropriate monitoring plan.  

The following document templates exist to assist you with developing your own monitoring plan or materials.  

• Data Safety Monitoring Plan (DSMP) 

• Monitoring Visit Report Template 

• Monitoring Analysis Template 

• Monitoring Assessment Guidance Document  

• Sponsor Monitoring Plan Guide   

Contact Lori Conley, Associate Director, Clinical Research Monitoring  at conley@upenn.edu to explore monitoring options and develop a quote.