Glossary
Comprehensive Adverse Events and Potential Risks An NCI-released outline of all adverse events that might be expected for a drug, given with associated likelihood
An institution that is designated by the NCI as a comprehensive or clinical cancer center and is eligible to conduct IND drug studies
Cancer Clinical Investigations Review Committee. The committee that is responsible for peer reviews of Group Competing grant applications (site visit).
Community Clinical Oncology Program. CCOP was a network agreement supported program which provides support to community-based oncologists to participate in clinical trials sponsored by the clinical network groups and/or cancer centers. Rebranded as NCORP (NCI Community Oncology Research Program) which launched on August 1, 2014.
Common Data Elements. A repository of terms to be used in the data collection forms for Phase III clinical trials
Clinical Data Updates System. CTEP’s web-based data submission system that allows groups to submit, access, and update data
NCI's Central Institutional Review Board. Institutions may utilize the CIRB in lieu of individual local IRBs to reduce the need for additional review for studies that are under CIRB purview. This includes all Phase III studies and select Phase II studies.
The former term for members who make up the NCI’s National Clinical Trials Network. Cooperative groups are composed of investigators who join together to develop and implement common protocols. The distinguishing characteristic of cooperative groups is the central operations and statistics offices that support the administrative requirements of the research and perform central data collection and analysis
Cancer clinical network groups are composed of investigators who join together to develop and implement common protocols. The distinguishing characteristic of network groups is the group chair, operations, and statistics and data management offices, which support the administrative requirements of the research and perform central data collection and analysis
The individuals at the institution who are responsible for clinical and data record collection and data submission to the statistics and data management centers. The head CRA is responsible for receiving information from the group, disseminating it and responding to requests.
Theradex Oncology is the company that receives, reviews, and performs data management service on individual patient case report forms for Phase I and some Phase II NCI investigational drug studies
This document contains all relevant information about the drug, including animal screening, preclinical toxicology, and detailed pharmaceutical data. Also included, if available, is a summary of current knowledge about pharmacology and mechanism of action and a full description of the clinical toxicities.
The decision by a group, institution, or the NCI to close a study to new patient accrual. Closures may be either temporary or permanent (See related entries below). (NOTE: When SWOG says “closed” it usually means the study has closed to accrual but patients will continue treatment. When SWOG says “closed B” it means the study has closed to accrual AND all patients are off treatment.)
Children’s Oncology Group. The only pediatric clinical trial group sponsored by the NCI, supporting research as one of the five members of the NCTN
The protocol has been closed to accrual, all patients have completed treatment, and the study has met its primary objectives. A final study report/publication has been submitted to CTEP. (NOTE: Before CIRB considers a study completed, all patients must have also competed follow-up.)
The concept is an investigator's outline for conducting trials in a particular disease. The concept outlines all key scientific, methodological, and statistical considerations required for comprehensive review. CTEP approval commits an investigator to submit a protocol within a specified timeframe
Cancer Research and Biostatistics, an administrative arm of the SWOG Statistics and Data Management Center
Cooperative Research and Development Agreement. An agreement between the NCI and a pharmaceutical company for the clinical co-development of an investigational agent
Common Terminology Criteria for Adverse Events. An NCI-supplied list of standard terminology to be used when grading adverse events
Cancer Therapy Evaluation Program, DCTD, NCI. A division of the NCI which funds cancer treatment trials
A regulation which requires SWOG member institutions to grant pharmaceutical collaborators licensing rights to applicable inventions developed during the course of a study
Newsletter which announces the approval of new drugs for clinical trials and other drug development information
CTEP Adverse Event Reporting System, NCI’s on-line SAE reporting mechanism (formerly AdEERS: Adverse Event Expedited Reporting System)
The Cancer Trials Support Unit. A project sponsored by the NCI for the support of a national network of physicians to participate in NCI-sponsored Phase III trials