Clinical Informatics
Protocol Development
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.
Clinical Research
iMedidata Rave is NCI’s clinical trials data management system for all new study builds effective 12/9/21. Rave collects clinical trial data using standard case report forms (CRFs) based on common data elements (CDEs). Information regarding new accounts, login, the user manual, quick guides for common tasks, and existing user Q&A sessions can be found here: Rave Portal - CCR Wiki (cancer.gov)
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).
J-Review
- J-Review Login (use ncidb-p253.nci.nih.gov:ocprod for Database Server and leave SAS Server box empty )
CCR OIT Systems
CRMS, PRES, PDTS and Protocol View systems are part of CCR OIT systems and below presentation provides an introduction
Protocol View allows you to search for, view, and download protocols for NCI-CCR clinical trials.
PRES (Patient Registration and Enrollment System)
PDTS (Protocol Deviation Tracking System)
The Protocol Deviation Tracking System (PDTS) is an application that allows the user to record protocol deviations, both minor and major as well as track non-adherence for CCR-held IND/IDE protocols.
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.
To contact the Labmatrix team for build information or training please email ncilabmatrixhelp@mail.nih.gov.
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.
Cancer Therapy Evaluation Program (CTEP)
AERS (Adverse Event 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.
Overview
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