About TrialDB

Open Source Solution

Yale TrialDB Team Solution

Features, Capabilities,
and Requirements

Technology Used

Publications

Third Party Resources

Contacts

Yale TrialDB Team

The Yale School of Medicine has its own TrialDB system managed by the TrialDB Team.  The team consists of TrialDB developers and study designers.  For most studies, contracting the Yale TrialDB Team is a better choice than the time, effort, and financial investment of the Open Source Solution.  Here are some of the benefits:

Experience

The Team has years of experience designing studies for a variety of situations.  The TrialDB developers and study designers work together with Principal Investigators and study staff to develop a customized clinical trial that collects and manages study data effectively and efficiently.

The team also attends workshops and conferences to keep abreast of new developments in the management of clinical trials.

Server Technology

The Technology Used section describes the servers, operating systems, and software we currently maintain. Using our technology means that there is no software or hardware to install, maintain and manage at a study location or a remote site.

Design

Study designers assist at every phase of a study:

• Developing paper Case Report Forms (CRFs) during the planning stage of the protocol so they closely match the electronic version in TrialDB; simplifying data entry and easing transition from the paper to the electronic format. 
• Creating study specific reports in addition to the standard reports
• Import existing data

Training

We provide customized, personal training for study staff on the use of TrialDB and specific study CRFs. 

Security

HIPAA Security

• All study designers receive HIPAA training and Human Subjects Protection training. 
• All TrialDB users must complete an authorization form stating that they are HIPAA trained and certified; and will act in full compliance of HIPAA regulations.

Physical Security

TrialDB Web and Oracle servers are housed and maintained by Yale University Information Services in the central machine room. There are four levels of security:  building, area, office/machine Room compartment, machine room, PLUS servers are password protected.

Data Security - backup

 A variety of security features at several different levels, including the following:

• The Oracle database provides a number of security features including password-protected login.
• Trial/DB itself enforces “role-based” user privileges: 1) “read only” access to that study’s data, 2) “read/edit” access, 3) the ability to create/modify the protocol’s data element definitions and screens, and/or 4) the ability to assign privileges.
• The protocol designer may specify whether patient names (or only patient IDs) are to be displayed on data entry forms.
• Trial/DB uses 128-bit SSL security to encrypt all Web-based communications.
• Trial/DB can maintain an electronic audit trail of all modifications to a study’s data, including the user who made the change, the date and time, and each data item that was changed together with its previous value and new value.
• Several levels of backup of the database are performed on a regular basis, including full backup daily and incremental backup during the day.

Reports

Standard reports and customized reports

Extracts

Data Management

• Automatic lab imports for Yale patients
• Importing existing data
• Exporting data for statistical analysis
• Exporting data to established external databases