Study Monitoring
Study Monitoring
The CTSI can provide assistance with clinical research monitoring on investigator-initiated trials.
This is a service under the CTSI Trial-CORE. These services are available to staff at both Ohio State and Nationwide Children's Hospital. At Nationwide Children's Hospital the CRC provides study monitoring services.
- Templates and Guidance- If you have a research team we can provide Study Monitoring templates, monitoring plans and guidance on how to ensure you have a strong data quality assessment.
- Staffing of Study Monitoring- An independent experienced staff member can be budgeted to provide regulatory oversight and source data verification paying special attention to the following items:
- Adverse Events
- Protocol Deviations
- Protocol specified Outcome Measures
- Regulatory Document Review
- Training Documentation
- Consent Process Documentations
- Inclusion/Exclusion Criteria Review
Contact Us
To learn more or to request a consultation, contact Amy Bartlett.
Amy Bartlett, BA, CCRC
Associate Director of Clinical Research Development
CLINICAL SERVICES CORE
Phone
