Clinical Trials Management Tools
The Clinical Trials Management Tools are a Java-based suite (accessed via a secure intranet) for managing various aspects of a clinical trial. Developed in collaboration with the Clinical Research Services (CRS) Office at the UPCI, this research-based application provides an integrated tool for managing administrative (e.g. IRB approvals) and clinical (e.g. tumor measurements) functions for the collection and analysis of data generated from a clinical trial.
Software features include:
Administrative and Regulatory
Allows collection and viewing information on status, study scope, accruals and regulatory requirements; supports studies with multiple disease sites, centers, performance sites and resources; manages contacts and communications for investigators; electronic document integration and web content support.
Enterprise Reporting
Provides standard and custom reports built using a Crystal™ Enterprise reporting architecture.
Clinical Data Management
Report forms capture adverse events, clinical responses, cultures, drug administration/concomitant, extent of disease, lab/test results, medical histories and physical exams; physician notes, prior therapies, and tumor markers
Patient Enrollment/Screening Registry tracks patient enrollment onto trials, collects treatment and referring physician, vitals and BSA calculations at time of registration, and monitors patient accruals.
Patient Calendar/Treatment Progress Chart provides a ‘day-planner’ view of all patient activities (e.g. treatment start date); allows treatment calendars to be generated and printed from the study schedule, and integrates and automates billing procedures.
Financial Management
Contract Info allows the collection and management of contract-related account information (i.e. account numbers, billing frequencies,etc.) associated with the sponsoring organization.
Treatment Schedule/Cost-mapping allows financial data to be linked to the treatment events in a matrix-like formation, utilizing a cost-mapping feature which can be used for a budget list or forecasting.
Institutional Accounts allows the designation of institutional specific account numbers for linkage to ancillary billing systems.
Transaction Monitor/Payment Distribution monitors all itemized billing activity, from payments received to individual billable events; allows payments received from sponsors to be tracked and distributed to the clinical trial accounts(s).
Data sources:
Enterprise Master Patient Index (EMPI), MARS, EPIC (Scheduling)
Standards/Vocabularies used:
| Adverse Events (AE’s) | NCI CTCAE (2.0 & 3.0) |
| Organizations | CTEP/CDUS Institution |
| Disease Site | ICDO3 |
| Disease Histology | ICDO3 |
| Staging | AJCC |
| Ethnicity | Impac (ICR) |
| Performance Status | ECOG/Zubrod & Karnofsky |
Future Data source needs:
Lab (Sunquest/Copath)
Tumor Measurements (Radiology)