Table 1.
Exemplary caBIG Tools and Applications
| Tool | Description |
|---|---|
| C3D | C3D is a CTMS that collects clinical trial data using standard case report forms based on common data elements; C3D provides trial managers a secure and standardized framework for collecting, tracking, auditing, and electronically submitting trial data across multiple studies and sites; this web-based application can be hosted at NCICB or locally at an individual institution* |
| CDS | The CDS is a web-based data submission system for NCI-sponsored clinical trials; the CDS also provides trial stakeholders and partners a centralized, password-protected portal for viewing and generating reports on submitted data; as a part of the caBIG clinical trials management software suite, CDS can also reuse data collected in C3D |
| C3PR | C3PR is a web-based application that helps organize and manage participant registration data collected in multi-center clinical trials; integrates with C3D |
| caAERS | An open-source software tool that is used to collect, process, and report adverse events that occur during clinical trials; integrates with C3D |
| caMatch/BreastCancerTrials.org | A system for identifying patients who are potentially eligible for clinical trials; a web-based application for breast cancer is available3 |
| Laboratory integration hub | The laboratory integration hub is an open source software tool used to collect, process and report laboratory data gathered during a clinical trial; integrates with C3D |
| Patient study calendar | PSC lets trial managers schedule treatment and care events for each participant in a clinical trial and follow their progress through each step of the trial protocol, from consent and registration through intervention and monitoring to long-term follow up; PSC is an open-source, standards-compliant software application that integrates with C3D |
| caTissue Core | caTissue Core is a tissue bank repository tool to collect, manage, process, annotate; and distribute biospecimens in many formats (ie, fixed tissue, frozen tissue, cell lines, and DNA, RNA or protein derived from them); a core solution for biospecimen inventory, tracking, and basic annotation; caTissue Core can be rapidly deployed by cancer centers that have no such system or to replace an aging legacy system; caTissue suite 1.0 is the comprehensive and integrated suite of tissue banking tools and applications, including caTissue Core, caTissue CAE, and caTIES |
| caTissue CAE | This clinical data mapping module retrieves data from basic medical records, drug treatments, surgery, radiology, tumor registries, and pathology laboratories and shares that data with the caTissue system; clinical descriptions are correlated to molecular data in a secure manner that maintains patient privacy; the system allows the integration of annotations from multiple sources within the cancer centers, providing a complete picture of a patient's disease |
| caTIES | This system automates the extraction of coded information from surgical pathology reports and presents it in a standardized format; users can query, browse, and acquire annotated tissue data and physical material |
| caTRIP | caTRIP connects existing data systems, including basic science data, to enhance patient care; the system leverages clinical, pathology, tissue, and basic science data, including data from existing patients, to inform the treatment of a new patient |
Abbreviations: C3D, Cancer Central Clinical Database; CTMS, clinical trials management system; CDS, Clinical Data System; C3PR, Cancer Central Clinical Participant Registry; caAERS, cancer Adverse Event Reporting System; caTissue CAE, caTissue Clinical Annotation Engine; caTIES, cancer Text Information Extraction System; caTRIP, cancer Translational Research Informatics Platform.
*Several commercial and open source vendors are also pursuing caBIG compatibility, which will enable interoperability with the components listed later in this Table.