Key System Features for Research Projects:
- Variety of input options (fax using optical character recognition, scan, web entry)
- Powerful and flexible data dictionary and subsequent ongoing query generation
- Real-time access to study data
- Real-time query generation and resolution
- Real-time audit trail
- Comprehensive reports for effective study management
Key System Benefits:
- Eliminates delays in identifying missing data
- Eliminates delays in cleaning data
- Real-time reports enable more efficient workflow
- Allows monitoring of study progress in real-time
- Rapid database lock
Study Database
A study database typically consists of multiple tables for actual data collection plus a number of standard supporting tables. The standard supporting tables include:
- Audit trail of changes to the database
- Rejected forms listing
- Clinic identifier information
- User comments associated with queries
- Data dictionary for within form queries
- Data dictionary for complex within form and cross form queries
- Query listing
- Variable Formats
- Form Descriptions
- User logons
System Security
All study data are housed in our data centers, where physical and digital security is a constant priority and access is monitored closely.
Remote access to the system is restricted (at both UCSF and the clinical sites) to approved personnel only. A log of all personnel with access is kept and updated in real time by our systems monitoring. All personnel are trained in security policies and said training is documented in a security training log.
Data sent over the Internet between the DEB web servers and the clinical sites is 256-bit SSL encrypted. UCSF Communication on the internal network between any client machine and SQL is encrypted at the 256-bit level. Once a user accesses the system they are only permitted to view data received from their site, and a number of aggregate reports. Users are not permitted to view or alter another clinic's data.
System Backup
Study data are backed up four times nightly. This includes sending the data off-site. All servers are backed-up in full nightly.
Additionally, specific procedures to fully restore the system in the event of partial or complete system failure (e.g. building destroyed) are outlined in validation documentation as dictated by UCSF DEB Standard Operating Procedures.
Site Hardware Requirements
The only hardware required for remote clinical centers is a PC workstation equipped with an Internet browser. Centers which choose to submit their data collection forms via fax or scanning will need to have hardware to do this. Minimum specifications for workstations and fax machines are distributed to clinical centers prior to the start of the study.