Glossary of CTRP Terms
A - D Terms
Abstraction - Identification and extraction ("abstraction") of information from the submitted protocol document by the NCI Clinical Trials Reporting Office (CTRO) staff to complete data element fields in the CTRP database.
Activation - The official start date of a trial determined as follows: 1) the date of an official clinical trial activation announcement or 2) the date of first patient accrual if the trial did not have a formal activation announcement.
Amendment - Amendments include changes that: 1) substantively alter the treatment administered; and/or 2) the study design; and/or 3) the sites in which patients are being enrolled on the trial. Amendments are to include all changes (including updates) since the last change to the protocol was submitted.
Ancillary/Correlative - A subgroup of non-interventional trials, defined as a trial that is secondary to another trial, or a type of trial that tests for a relationship between a condition and a potential causal factor of the condition.
Arm label - The short name used to identify the arm. (Source: http://prsinfo.clinicaltrials.gov/definitions.html)
Arm description - A brief description of the arm. (Source: http://prsinfo.clinicaltrials.gov/definitions.html)
Arm type -
- Experimental: An arm or group in which an experimental drug or regimen is being administered. This will be used when the trial specifies that one arm is a control arm and the other is experimental, or when the other arm is a placebo arm. In cases where patients are not randomized but assigned to groups according to certain characteristics (e.g., risk characteristics, age, diagnosis), use "experimental" for all groups/strata because they are not being compared.
- Active comparator: An arm or group in which active drugs are given. This will include arms that are mixing active drugs and placebos. This will be used when the term "control arm" is specified in the protocol and when another arm is designated as the experimental arm. There can be more than one active comparator arm.
- Placebo comparator: An arm or group in which ONLY a placebo is given.
- Sham comparator: An arm or group in which ONLY a mock therapy that is not a drug is administered.
- No intervention: An observational arm or group.
- Other: An arm or group which does not fall into any of the categories above.
Basic Science- A protocol designed to examine the basic mechanism of action (e.g., physiology, biomechanics) of an intervention. (Source: http://prsinfo.clinicaltrials.gov/definitions.html)
Categories for Trials in CTRP -
- National: NCI National Clinical Trials Network (NCTN) and other NIH-supported National Trial Networks.
- Externally Peer-Reviewed: R01s, SPORES, U01s, U10s, and P01s or other trial mechanisms supported by the NIH or supported by other peer-reviewed funding organizations.
- Institutional: In-house clinical research studies authored or co-authored by Cancer Center investigators and undergoing scientific peer-review solely by the Protocol Review and Monitoring System of the Cancer Center. The Cancer Center investigator has primary responsibility for conceptualizing, designing, and implementing the clinical research study and reporting results. It is acceptable for industry and other entities to provide support (e.g., drug, device, other funding), but the trial should clearly be the intellectual product of the Center investigator.
- This category may also include: 1) Institutional studies authored and implemented by investigators at another Center; 2) Multi-site institutional studies authored and implemented for which the Cancer Center is the lead organization.
- Industrial/Other: Design and implementation of the study is controlled by the pharmaceutical company or by another organization that is not NCI supported.
Clinical Trials Reporting Program (CTRP) - CTRP is a comprehensive database of regularly updated information, including trial accrual, on all NCI-supported clinical trials.
Clinical Trials Reporting Office (CTRO) - The functional unit that performs the operational work of the Clinical Trials Reporting Program (CTRP), including protocol abstraction.
CCR - NCI's Center for Cancer Research is the basic and clinical intramural research program of NCI.
CDP - NCI's Cancer Diagnosis Program stimulates and supports diagnostics research, resources, and improved technologies to guide the choice of treatment for cancer patients.
CDUS - The Clinical Data Update System is the primary data reporting mechanism for CTEP and DCP PIO managed clinical trials and is used by CTEP and DCP to enter and submit accrual data to CTRP.
CIP - NCI's Cancer Imaging Program, located within the Division of Cancer Treatment and Diagnosis, evaluates imaging in diagnosis, disease staging, and treatment monitoring.
CTEP - The Cancer Therapy Evaluation Program, located within the Division of Cancer Treatment and Diagnosis, assesses new anticancer agents, radiation treatments, and surgical methods.
CTMS - The Clinical Trials Monitoring Service, a data service used to submit data on early phase trials to CTEP.
Data Table 4 - The revised version of the NCI Cancer Centers Program's Summary 4 Report.
DCB - NCI's Division of Cancer Biology supports and facilitates basic research in all areas of cancer biology at academic institutions and research foundations across the United States and abroad.
DCCPS - NCI's Division of Cancer Control and Population Sciences supports a comprehensive program of genetic, epidemiologic, behavioral, social, and surveillance cancer research.
DCP - NCI's Division of Cancer Prevention supports research to determine and reduce a person's risk of developing cancer, as well as, research to develop and evaluate cancer screening procedures.
DCTD - NCI's Division of Cancer Treatment and Diagnosis supports the translation of promising research areas into improved diagnostic and therapeutic treatments for cancer patients.
DEA - NCI's Division of Extramural Affairs coordinates the scientific review of extramural research before funding, and provides systematic surveillance of that research after awards are made.
Diagnostic - Protocol designed to evaluate one or more interventions aimed at identifying a disease or health condition. (Source: http://prsinfo.clinicaltrials.gov/definitions.html)
Diagnostic procedure - Methods, procedures, and tests performed to diagnose disease, disordered function, or disability. (Source: http://ncimeta.nci.nih.gov/ncimbrowser/ConceptReport.jsp?dictionary=NCI%20MetaThesaurus&code=C0430022)
DTP - NCI's Development Therapeutics Program, located within the Division of Cancer Treatment and Diagnosis, funds drug discovery and development and provides related services.
E - J Terms
Expanded Access - Records describing the procedure for obtaining an experimental drug or device for patients who are not adequately treated by existing therapy, who do not meet the eligibility criteria for enrollment on a clinical trial, or who are otherwise unable to participate in a controlled clinical study. Expanded Access records are used to register all types of non-protocol access to experimental treatments, including protocol exception, single-patient IND, treatment IND, compassionate use, emergency use, continued access and parallel track. (Source: http://prsinfo.clinicaltrials.gov/definitions.html)
Extensible Markup Language (XML) - A general-purpose markup language for creating special-purpose markup languages that is capable of describing many different kinds of data. Its primary purpose is to facilitate the sharing of data across different systems, particularly systems connected via the Internet. (Source: http://ncimeta.nci.nih.gov/ncimbrowser/ConceptReport.jsp?dictionary=NCI%20MetaThesaurus&code=C1707981)
FDA - One of the agencies of the U.S. Department of Health and Human Services. It assures the safety of foods and cosmetics, and the safety and efficacy of pharmaceuticals, biological products, radiation emitting products, medical devices, and also, animal feed and drugs. (Source: http://ncimeta.nci.nih.gov/ncimbrowser/ConceptReport.jsp?dictionary=NCI%20MetaThesaurus&code=C0041714)
FDAAA - The Food and Drug Administration Amendments Act of 2007, P.L. 110-85 that defines requirements for clinical trials reporting to ClinicalTrials.gov.
Grant number (NIH and/or NCI grants) - A grant number is a series of a number of elements that identifies grants specifically funded by NCI or NIH, which provide the monies for the trials or infrastructure associated with the research.
|Type||Funding Mechanism||Institute Code||Serial Number||Year||Suffix|
Type: A single-digit code that appears at position 1 of the example. It identifies the type of application received and processed.
Funding Mechanism: A three-character code, located at position 2-4. It is used to identify areas of extramural research activity applied to funding mechanisms.
Institute Code: A two-character code, position 5-6 which identifies the NIH Institute that directly funded the award. It identifies the first major-level subdivision and the organization that supports a grant, contract, or inter-agency agreement. The support may be financial or administrative.
Serial Number: A 6 digit number, position 7-12. Assigned sequentially to a series within an Institute, Center, or Division. Used as an identifier for the grant.
Year: A two-digit number, position 13-14 usually indicating the current year within an award. Indicates the actual segment or budget period of a project.
Suffix: A numeric or alphanumeric string, beginning in position 15. It is the code that identifies grant supplement, amendment or a fellowship's institutional allowance. Suffix designation follows the grant year.
Also consult NIH Grants Glossary.
Health Services Research - A protocol designed to evaluate the delivery, processes, management, organization or financing of health care. (Source: Protocol Registration System Information)
IDE - Investigational Device Exemption, an FDA exemption that allows an investigational device to be used in a clinical study in order to collect safety and effectiveness data. (Source: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/InvestigationalDeviceExemptionIDE/).
Investigational New Drug (IND) - The legal mechanism under which experimental agent research is performed in the United States. An IND is submitted to the Food and Drug Administration (FDA) in order to receive an exception from premarketing approval requirements so that experimental clinical trials may be conducted. (Source: CTEP Investigator's Handbook- http://ctep.cancer.gov/investigatorResources/investigator_handbook.htm)
Interventional trial - Studies in human beings in which individuals are assigned by an investigator based on a protocol to receive specific interventions. Subjects may receive diagnostic, therapeutic, behavioral or other types of interventions. The assignment of the intervention may or may not be random. The individuals are followed and biomedical and/or health outcomes are assessed. (Source: http://prsinfo.clinicaltrials.gov/definitions.html)
IRB - A specially constituted independent review body comprised of medical, scientific, and non-scientific members established and designated by an entity to ensure the protection of the rights, safety and well-being of human subjects recruited to participate in biomedical or behavioral research according to the requirements outlined in Title 38, part 16 (same as Title 45, part 46 and Title 21, part 56) of the U.S. Code of Federal Regulations. IRB responsibility include but not limited to the reviewing, approving, and providing continuing review of trial protocol and amendments and of the methods and material(s) to be used in obtaining and documenting informed consent of the trial. Other equivalent committees with the same or similar functions are also considered to be IRBs. (Source: http://ncimeta.nci.nih.gov/ncimbrowser/ConceptReport.jsp?dictionary=NCI%20MetaThesaurus&code=C0086911)
K - O Terms
Lead organization - The organization responsible for the overall scientific and administrative coordination, study monitoring, and data management activities of a particular clinical trial.
Lead organization trial identifier - One or more characters assigned by the organization providing oversight for the study to identify, name, or characterize the protocol document.
Non-interventional studies - Studies in human beings in which biomedical and/or health outcomes are assessed in pre-defined groups of individuals. Subjects in the study may receive diagnostic, therapeutic, or other interventions, but the investigator does not assign specific interventions to the subjects of the study. (Source: http://prsinfo.clinicaltrials.gov/definitions.html)
NCAB - The National Cancer Advisory Board (NCAB). Advises the HHS secretary and the NCI director with respect to the activities of the NCI, including reviewing and recommending for support grants and cooperative agreements, following technical and scientific peer review. (www.cancer.gov)
NCI-supported (trials) - All trials sponsored or otherwise financially supported by NCI.
Observational trials/studies - Studies among cancer patients and healthy populations that involve no interventions or alteration of the participants. (Source: http://ncimeta.nci.nih.gov/ncimbrowser/ConceptReport.jsp?dictionary=NCI%20MetaThesaurus&code=C1518527)
OD - NCI's Office of the Director.
OGA - NCI's Office of Grants Administration manages all NCI business-related activities associated with the negotiation, award, and administration of grants and cooperative agreements. (www.cancer.gov)
OSB/SPOREs - NCI's Organ Systems Branch/Specialized Programs of Research Excellence.
P - Z Terms
Phase (trial) - Phase of investigation, as defined by the US FDA for trials involving investigational new drugs (Source: http://prsinfo.clinicaltrials.gov/definitions.html)
Phase 0 (trial) - Exploratory trials, involving very limited human exposure, with no therapeutic or diagnostic intent (e.g., screening studies, microdose studies) (Source: http://prsinfo.clinicaltrials.gov/definitions.html)
Phase 1 (trial) - Includes initial studies to determine the metabolism and pharmacologic action of drugs in humans and the side effects associated with increasing dose may include healthy participants and/or patients. (Source: http://prsinfo.clinicaltrials.gov/definitions.html)
Phase 1/2 (trial) - For trials that are a combination of Phases 1 and 2 (Source: http://prsinfo.clinicaltrials.gov/definitions.html)
Phase 2 (trial) - Includes controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in patients with the disease or condition under study and to determine the common short-term side effects and risks (Source: http://prsinfo.clinicaltrials.gov/definitions.html).
Phase 2/3 (trial) - For trials that are a combination of phases 2 and 3 (Source: http://prsinfo.clinicaltrials.gov/definitions.html)
Phase 3 (trial) - Includes expanded controlled and uncontrolled trials after preliminary evidence suggesting effectiveness of the drug has been obtained. Phase 3 trials are intended to gather additional information to evaluate the overall benefit-risk relationship of the drug and provide an adequate basis for physician labeling (Source: http://prsinfo.clinicaltrials.gov/definitions.html)
Phase 4 (trial) - Studies of FDA-approved drugs to delineate additional information including the drug's risks, benefits, and optimal use (Source: http://prsinfo.clinicaltrials.gov/definitions.html).
Phase-N/A (trial) - For trials without phases.
Pilot Trials - The initial study examining a new method or treatment.
PIO - A Protocol and Information Office within NCI's CTEP and DCP that is responsible for registering and reporting accrual data associated with the interventional trials they manage to CTRP.
Prevention - Protocol designed to assess one or more interventions aimed at preventing the development of a specific disease or health condition (Source: http://prsinfo.clinicaltrials.gov/definitions.html)
Primary Purpose - Reason for the protocol. (Source: http://prsinfo.clinicaltrials.gov/definitions.html). The primary purpose of protocols is classified as follows:
|Treatment||Protocol designed to evaluate one or more interventions for treating a disease, syndrome or condition.|
|Prevention||Protocol designed to assess one or more interventions for preventing, or decreasing the chance of getting, a specific disease or condition. For example, cancer prevention may include avoiding risk factors and increasing protective factors.|
|Screening||Protocol designed to assess or examine methods of identifying a condition (or risk factors for a condition) in people who are not yet known to have the condition (or risk factor).|
|Supportive Care||Protocol designed to evaluate one or more interventions where the primary intent is to maximize comfort, minimize side effects or mitigate against a decline in the subject's health or function. In general, supportive care interventions are not intended to cure a disease.|
|Basic Science||Protocol designed to examine the basic mechanism of action (e.g., physiology, biomechanics) of an intervention.|
|Diagnostic||Protocol designed to evaluate one or more interventions aimed at identifying a disease or health condition.|
|Health Services Research||Protocol designed to evaluate the delivery, processes, management, organization or financing of health care.|
|Other||Protocol not in other categories, and is defined in free text.|
Principal Investigator (PI) - Name of the physician who has organizational and fiscal responsibility for the use of federal funds to conduct a clinical study.
Program Code - A unique reference code (e.g., 01, 02, or GYN, GU) assigned by the Cancer Center to each program and reported to CTRP at time of initial trial registration.
Registration (as it pertains to CTRP trial) - The initial clinical trial data provided to CTRP by an NCI-awardee and/or site.
Screening - Protocol designed to assess or examine methods of identifying a condition (or risk factors for a condition) in people who are not yet known to have the condition (or risk factor). (Source: prsinfo.clinicaltrials.gov/definitions.html)
Status Change - Status changes include changes in the overall status of the trial (e.g., a change from active to temporarily closed to accrual, a change from temporarily closed to accrual to complete, etc).
Submitting organization - Awardee and/or site who is supplying trial data to NCI's Clinical Trials Reporting Program (CTRP).
Supportive care - Protocol designed to evaluate one or more interventions where the primary intent is to maximize comfort, minimize side effects or mitigate against a decline in the subject's health or function. In general, supportive care interventions are not intended to cure a disease. (Source: Protocol Registration System Information)
Treatment - Protocol designed to evaluate one or more interventions for treating a disease, syndrome or condition. (Source: Protocol Registration System Information)
Trial status - The current stage or state of a clinical trial or study relative to other stages and its ability to enroll participants / patients. Trial status types include:
- In Review. Trial is currently under IRB review
- Withdrawn. Trial has been withdrawn from development and review prior to enrollment of the first participant.
- Approved. Trial has been approved, but is not yet recruiting or enrolling participants.
- Active. Trial is open for accrual and enrollment.
- Enrolling by Invitation. Participants are being (or will be) selected from a predetermined population.
- Temporarily Closed to Accrual. Participant recruitment or enrollment has been halted prematurely but may resume. Participants already on trial continue to receive intervention.
- Temporarily Closed to Accrual and Intervention. Participant recruitment or enrollment has been halted prematurely but may resume. Participants already on trial do not receive intervention.
- Closed to Accrual. Trial has been closed to participant accrual, but trial is ongoing (i.e., participants continue to receive treatment and/or examination).
- Closed to Accrual and Intervention. Trial has been closed to participant accrual. Participants already on trial do not receive treatment, but continue to be monitored for endpoints such as long-term survival.
- Administratively Complete. Participant recruitment or enrollment has been halted prematurely (for example, due to poor accrual, insufficient drug supply, IND closure, etc.), and will not resume. Participants already on the the trial do not receive further treatment or examination.
- Complete. Trial has been closed to accrual and follow-up. Participant treatment/intervention has been completed and participants are no longer monitored for trial endpoints (i.e., last patient's visit has occurred). The trial has met its objectives.
Trial type - Nature of the investigation that includes interventional, non-interventional (observational and ancillary/correlative), and expanded access studies.
Update - Changes to the protocol that do not substantively affect the scientific conduct of the study, the study design, and/or the sites in which patients are being enrolled on the trial (e.g., all changes to the protocol that do not fall into the definition of amendments).