Data and Safety Monitoring
What
The IRB ensures that every research protocol has an adequate monitoring plan in place to assure the safety of research subjects [45 CFR 46.111(a)(6) and 21 CFR 56.111(a)(6)]. The type and degree of monitoring required is related to the degree of risk involved, nature, size, and complexity of the research study.
How
To learn more about the monitoring plan requirements, see Data Safety Monitoring Plans.
Data Collection and Management
eRAP
The eRAP Rapid Database Generator (eRAP RDG) is a 21 CFR Part 11 compliant web-based interactive tool for data entry and reporting. eRap can be used to develop custom databases for longitudinal single and multi-site studies. Services include:
- Reporting tools
- Randomization engine
- Data upload
- File upload
REDCap (Research Electronic Data Capture)
REDCap is a secure, self-service, web based electronic data capture system that can be used to build and manage surveys and databases.
Some features of REDCap include:
- Fast and flexible
- Customizable
- Send files securely
- Export data to Excel and statistical packages (SAS, SPSS, R, Stata)
- REDCap API
- Import data
- HIPAA and 21 CFR Part 11 Compliant
Research 411 Portal
Still Need Help?