Data Management

Research IT provides full database development and support using Mount Sinai's own Rapid Database Generator Toolkit© (RDG). RDG is a Web-based interactive toolkit that allows Research IT to collaborate with investigators to quickly develop and deliver custom databases for single and multi-site longitudinal studies. Delivery of databases through Mount Sinai's secure Web-based Electronic Research Application Portal© (eRAP) gives investigators access to their research data when and where they need it. eRAP's Role-Based Access Control security and audit capability ensures that the investigator's research data is protected from unauthorized access, modification, and exposure.

Key features of RDG include:

  • User-defined field creation with data validation, business rules, algorithms, and calculations
  • Ability to create dynamic forms to facilitate accurate data entry
  • Record lock to support quality assurance and data monitoring
  • Electronic Signature
  • PDF document creation within application using MSSQL reporting services
  • File upload and management
  • Data viewing across projects for same master patient

Other key features of our data management capability include:

Multi-site Studies

  • Databases can be created to allow data entry from multiple locations. Each site can have separate pool of data as required by the study
  • Data views can be customized by site, if necessary
  • The study Data Coordinating Center can view all sites
  • Security can be modified to limit access to identifiers for any research subject, whether human or non-human
  • Data sets can be extracted per site or per study

User-defined fields (UDFs) support all field types:

  • Text Field
    • Character
    • Date (include Date Picker - Calendar)
    • Number
    • Currency
  • Memo Field
  • Multi Select Checkbox
  • Single Select Dropdown Code List
  • Single Select Radio Buttons
  • Yes/No Option
  • Label (HTML-enabled message field)
  • Table Fields

UDF Business Logic

  • Text Field
    • Calculations
    • Algorithms to score forms and support data entry flow
    • Data Range (for Number and Date)
  • Single/Multi Select, Yes/No
    • Show/Hide fields based on data entry
  • Field mapping to pre-populate data

File Upload Service

Reporting and Data Extract

  • Ability to create reports on any UDFs
  • Versatile filter function on any or multiple UDFs
  • Ability to export data to Excel or flat text file for easy import into SAS or other statistical packages
  • Ability to customize report/filters by user roles
  • Ability to link to MSSSQL reporting services

Integration with Medical Center Systems

  • EDR/Cerner for patient lookup
  • LIMS and caTISSUE Suite for specimen management
  • SCC clinical lab system for orders and results
  • Data Warehouse for associated clinical data on research subjects

Data Security

  • Portal security is based on the industry standards for Role-Based Access Control (American National Standard for Information Technology - Role Based Access Control. Technical Report INCITS 359--2004, American National Standards Institute, Inc., 3 February 2004)
  • Portal is approved by Mount Sinai IT Security and HIPAA
  • Secured data transfer via HTTPS protocol
  • High-end servers located in the Secured Mount Sinai Data Center
  • All data is backed up daily
  • Access to database controlled by policies requiring investigator or database owner to authorize user and user roles
  • Quick-view audit service allows authorized user to see who accessed records for view or edit
  • Detailed audit service including data field level changes, who changed, when, old value, new value