Quality Services:

• Websites
• Customized to meet our clients' needs
• For all studies in which we provide data management support, an extranet website is provided to share project documentation, reports/updates and data (i.e., data can be entered into the website or data files can be uploaded to the website)
• Secure Data transfer features (SSL)
• Restricted Access (authorization required) and user level access assigned to specific modules of the website
• Tracking Systems
• One-to-one correspondence with the study protocol
• Subject identification information is encrypted to ensure confidentiality
• Three types of reports to facilitate appropriate subject follow-up:
• Action: Subjects due for a specific follow-up contact
• Information: Subject information to initiate contact
• Summary: Enrollment status, follow-up completion rates, etc.
• Scheduled system back-ups are uploaded to the website to cross-check data from multiple sources and to provide overall project recruitment and follow-up information
• Adverse events are flagged and reported
• Data Entry Systems
• Customized systems are developed for use at DM-STAT, off-site and the website
• Each system has restricted access and quality control features (e.g., range and logic checks)
• Reporting features include, but are not limited to, listing of subject and corresponding items requiring data clarification, status reports (number of forms entered, double entered, etc.), data entry error rate by operator and customized reports for key items

Continuous Communication:

• We have staff that specialize in database architecture, programming and technical writing.
• Prior to software implementation, all specifications and systems are reviewed, tested and approved by the client.
• Initial testing is performed by DM-STAT staff and the client, at which time, training and documentation are provided.
• Once testing is complete the client will have a pilot-testing period in which modifications will be made (if required).
• DM-STAT will remain available to the client for trouble shooting, modifying or updating the system during the lifetime of the project.

Extensive Documentation:

• User manuals accompany each system and describe all aspects of the system. Manuals include prints of each screen and functionality of each object (e.g., button) on a given form
• Data dictionaries provide item coding and data entry information
• Updates to documentation are available via the project website