- Legal review of research-related contracts/agreements
- Financial review of study budgets, as applicable
- Medicare Coverage Analysis, as indicated
- Regulatory preparation, and coordination of IRB submission including required training in human subject protections by all key personnel
- Screening, recruiting, and enrolling study subjects
- Manage subject visits
- Perform study procedures
- Manage subject data reporting
- Identification and reporting of adverse events
- Participate in audits and study monitor visits
- Build studies in Epic linking study visits to the subject in the EHR
- Ongoing study finance management
Research Electronic Data Capture (REDCap) is available to research clinicians throughout CommonSpirit, including health professionals within and affiliated with a CommonSpirit entity. REDCap, created by Vanderbilt University in 2014, is supported by the REDCap Consortium to primarily facilitate Institutional Review Board-approved (IRB) clinical research.
The web application is licensed to CommonSpirit and is a go-to method for supporting both single and multi-site research studies. REDCap is utilized for building and managing online surveys and databases. The features include:
- Secure full user authentication, user rights, data validation, secure data storage, de-identification and audit trail ability.
- Data downloads to common statistical application (SPSS, SAS, Strata and .csv) formats. Users may also import data through Microsoft Excel.
- Advanced features include file uploading, auto-validation, branching logic, calculated fields, signature, Dynamic Query (SQL).
There may be projects not research related where REDCap is an appropriate platform for data acquisition and management.