Protocol Development and Management
iRIS (Integrated Research Information System (iRIS) helps create, manage and process CCR research protocols. iRIS can be accessed from any computer that has a connection to the NIH internal network.
CRIS (Clinical Research Information System) is the NIH Clinical Center’s hospital information system.
C3D (Cancer Central Clinical Database) is NCI’s clinical trials data management system. C3D collects clinical trial data using standard case report forms (CRFs) based on common data elements (CDEs). C3D currently supports electronic submission of clinical trials data to the NCI’s Clinical Data System (CDS) and the Clinical Trials Monitoring Service (CTMS/Theradex).
Protocol View allows you to search for, view, and download protocols for NCI-CCR clinical trials.
Cancer Therapy Evaluation Program (CTEP)
AdEERS (Adverse Event Expedited Reporting System) is NCI's Web-based system for submitting expedited reports for serious and/or unexpected events forwarded to designated recipients and the NCI for all trials using a NCI-sponsored investigational agent.
CDS (Clinical Data System - Web) is the primary resource of clinical trial data for all of NCI. CDS reports are submitted for all NCI-sponsored trials (Phase 1, 2 and 3).
Theradex holds the Clinical Trials Monitoring Service (CTMS) contract for the NCI. The ACES (Automated Clinical Evaluation System) provides an electronic version of the standard CTMS Case Report Form for use by study sites for the capture of clinical data and the automated transfer of this data to CTMS.
LabMatrix is a Web-accessible clinical and translational research software system used for information management and integration of patient clinical, specimen, genetic, and molecular assay data.
BTRIS (Biomedical Translational Research Information System) is a resource available to the NIH intramural community that brings together clinical research data from the Clinical Center and other NIH Institutes and Centers. BTRIS provides clinical investigators with access to identifiable data for the subjects on their own active protocols, while providing all NIH investigators with access to de-identified data across all protocols.
VAERS (Vaccine Adverse Event Reporting System) is a national vaccine safety surveillance program co-sponsored by the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA).