Clinical Informatics

Protocol Development

PROTECT is the NIH IRBO's system to manage the protocol development and approval process; it is accessible from both the NIH network and the public internet.

iRIS (Integrated Research Information System (iRIS) helps create, manage and process CCR's animal research protocols; it 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; it went live in December 2021, and is now in use for all new and most current protocols. 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 on the Rave Portal.

C3D (Cancer Central Clinical Database) is NCI’s previous clinical trials data management system; most studies have been, or are being, migrated from C3D to Rave.

J-Review

  • J-Review Login (use ncidb-p253.nci.nih.gov:ocprod for Database Server and leave SAS Server box empty )

CCR OIT Systems

PINS, PRES, PDTS and Protocol View are all systems that that allow viewing and maintenance of CCR's protocol metadata — protocol information, subject enrollment, deviation reporting, etc. (This presentation provides a more detailed explanation of the differences between the systems.)

PRES (Patient Registration and Enrollment System)

PRES manages all study subject enrollment in CCR studies, and is where the full lifecycle of enrollments are recorded (on-study, off-treatment, off-study, etc.).

PINS (Protocol Information & Navigation System)

PINS is the main metadata repository for all CCR's clinical studies.

PDTS (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.

Protocol View allows you to search for, view, and download protocols for NCI-CCR clinical trials.

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.
Last updated by Levine, Jason (NIH/NCI) [E] on Dec 13, 2024