Indication: Dermatitis
Type of Study: Chart Review
Sponsor: Longitudinal observational patient registry
Patient Population: 1500
Investigative Sites: 100
An electronic data capture tool was designed and hosted for a national registry to assess patient characteristics, treatment patterns and clinical, economic and quality of life outcomes associated with a dermatologic disorder. A hybrid approach was used to collect data by incorporating a study website with browser-based physician and patient data collection forms, as well as traditional paper-based methods for patients who were not Internet-capable.
Indication: Scleroderma
Type of Study: Patient Registry
Sponsor: U.S. pharmaceutical company
Patient Population: 250
Investigative Sites: 15
An on-line EDC solution was designed in support of a prospective, observational study of patients diagnosed with scleroderma. Approximately 250 patients were enrolled at 15 sites. Data was collected directly from patients and health care providers via electronic patient questionnaires with visual diagrams. Real-time project management and clinical benchmark reports were provided to track study progress, data cleanliness and patient outcomes. The solution prompts patients and physicians for regular study visits, allows collection of ad-hoc visits and collects patient reports via email submission.
