TrialDB is a customizable Web-based clinical trials database system used for the storage and management of clinical data. It relies on a rich data library that contains information about individual data elements (parameters, typically clinical facts about patients) and their higher-order grouping. The library is used to generate case report forms (CRF) as Web pages, and records both information used to interactively validate the contents of the CRF as well as specify how individual elements in the CRF are presented to the user. The forms support validation of individual elements based on data type, range, and non-empty checks, as well as arbitrarily complex validation across the elements in a form (or across more than one form). They support skip logic, where certain elements are dynamically enabled or disabled based upon the values of previously entered elements. Access to a number of controlled vocabularies (e.g., ICD-10, DSM-IV, the Cerner/Multum Drug Lexicon, the NCI Common Toxicity Criteria) during data entry is also supported.
It can manage an arbitrary number of studies, with no limits on the number of patients per study or the number of parameters that are tracked in each study. It does all of this without the need to modify the database structure repeatedly each time you capture parameters for a new clinical domain.
This generic, open-source Clinical Study Data Management System (CSDMS) is available for use in two ways:
Open Source Solution
While copyrighted by its creators and developers, TrialDB is freely available under the GNU General Public License. Study managers can download TrialDB and setup the CSDMS locally.
Yale TrialDB Team Solution
The Yale TrialDB Support Team can be contracted to design and implement studies; and the Yale TrialDB installation can house data.
TrialDB is currently being used for a large number of clinical studies (90+) within Yale, most of which are investigator-initiated (i.e., not FDA-regulated), spanning the range from cancer, pediatrics, surgery, cardiology, geriatrics and psychiatry. It is also deployed at the Massachusetts General Hospital Department of Biostatistics for use by investigators within NCI's Cancer Genetics Network, and at the Harvard Department of Molecular Biology for the NIGMS's GLUE trauma consortium. It has been successfully deployed at the Children's Hospital of Eastern Ontario, Ottawa, Canada, the University of Brno, Czech Republic. Microsoft SQL Server versions are in use at the Johns Hopkins Center for Aging, the Department of Pediatrics at the University of Utah Medical School, and the University of Alabama, Birmingham, cancer center.
Funding and Financial Support
TrialDB's development has been primarily supported by the National Institutes of Health, chiefly the National Cancer Institute (through an award to Dr. Nadkarni via the Cancer Genetics Network). Additional support is being provided by the National Institute of Environmental Health Sciences and the National Institute of General Medical Sciences (via a Pharmacogenetic Network award to Dr. Nadkarni), the National Institute of Occupational Safety and Health (through a subcontract to Dr. Nadkarni from the Mt. Sinai school of Medicine, NY) and the National Center for Research Resources (via a GCRC award to Yale Medical School).
In its early stages, significant institutional funding was also provided from the Yale Cancer Center through the good offices of Prof. Vincent DeVita MD, Director, YCC. Prof. DeVita was the prime motivator for TrialDB in articulating the need for a robust clinical trials database.