Glossary of CTRP Terms
A - D Terms
Abbreviated – A category for CTRP registration, trials in this category are Industrial trials. The design and implementation of these studies is controlled by the pharmaceutical company. A protocol document is not required for registration of trials in this category.
Abstraction (trial) - 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 - In the CTRP, this term usually refers to the official start date of a trial determined as follows 1) the date in an official clinical trial activation announcement or 2) date of first patient accrual if the trial in question 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.
Arm label - The short name used to identify the arm (Source: Protocol Registration System Information)
Arm description - A brief description of the arm (Source: Protocol Registration System Information)
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 above
Categories for Trials in CTRP -
- National: A category of trials in CTRP, National Cooperative Group Trials.
- 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 trials authored or co-authored by cancer center investigators and undergoing scientific peer-review solely by the Protocol Review and Monitoring System of the center. The center investigator should have primary responsibility for conceptualizing, designing, and implementing the trial and reporting results. It is acceptable for industry and other entities to provide some support (e.g., drug, device, other funding) but the trial should clearly be the intellectual product of the center investigator.
- Industrial: Design and implementation of the study is controlled by the pharmaceutical company.
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.
Complete - A category for CTRP registration, trials in this category include National, Externally Peer-Reviewed, and Institutional interventional trials. A protocol document is required for registration of trials in this category.
Diagnostic - Protocol designed to evaluate one or more interventions aimed at identifying a disease or health condition (clinicaltrials.gov)
Diagnostic procedure - Methods, procedures, and tests performed to diagnose disease, disordered function, or disability. (NCI Thesaurus)
E - J Terms
Expanded Access - A study type that addresses the process 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: Protocol Registration System Information)
Extensible Markup Language (XML) - A general-purpose markup language for creating special-purpose markup languages. It 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: NCI] C45967
Grant number (NIH and/or NCI grants) - A grant number is a concatenation 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 - Protocol designed to evaluate the delivery, processes, management, organization or financing of health care. (Source: Protocol Registration System Information)
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 in order to receive an exception from premarketing approval requirements so that experimental clinical trials may be conducted.
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 assessed. (Source: Protocol Registration SystemInformation)
K - O Terms
Lead organization - The clinical study lead organization is an organization responsible for the overall scientific and administrative coordination, study monitoring, and data management activities of a particular clinical trial. (NCI Thesaurus C70790)
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.
Observational trials/studies - Studies among cancer patients and healthy populations that involve no intervention or alteration in the status of the participants. [Source: NCI] C16084 Defined as 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.
P - Z Terms
Phase 0 (trial) - Exploratory trials, involving very limited human exposure, with no therapeutic or diagnostic intent (e.g., screening studies, microdose studies) (Source: Protocol Registration System Information). See FDA guidance on exploratory IND studies for more information.
Phase I (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: Protocol Registration System Information).
Phase I/II (trial) - For trials that are a combination of Phases 1 and 2.(Source: Protocol Registration System Information).
Phase II (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: Protocol Registration System Information).
Phase II/III (trial) - For trials that are a combination of phases 2 and 3 (Source: Protocol Registration System Information).
Phase III (trial) - Includes expanded controlled and uncontrolled trials after preliminary evidence suggesting effectiveness of the drug has been obtained, and 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: Protocol Registration System Information).
Phase IV (trial) - Studies of FDA-approved drugs to delineate additional information including the drug's risks, benefits, and optimal use (Source: Protocol Registration System Information).
Phase-N/A (trial) - For trials without phases (Source: Protocol Registration System Information) This includes pilot trials in CTRP.
Primary Purpose: Reason for the protocol (Source: Protocol Registration System Information). The objective of the trial, especially with regard to the type of trial and its targeted outcomes. For clinicaltrials.gov the valid value list includes the following:
|Treatment||[CT.GOV] Protocol designed to evaluate one or more interventions for treating a disease, syndrome or condition.|
|Prevention||[CT.GOV] Protocol designed to assess one or more interventions aimed at preventing the development of a specific disease or health condition.|
|Screening||[CT.GOV] 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||[CT.GOV] 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||[CT.GOV] Protocol designed to examine the basic mechanism of action (e.g., physiology, biomechanics) of an intervention.|
|Diagnostic||[CT.GOV] Protocol designed to evaluate one or more interventions aimed at identifying a disease or health condition.|
|Health Services Research||[CT.GOV] Protocol designed to evaluate the delivery, processes, management, organization or financing of health care.|
|Other||[CT.GOV] not in other categories, requires Detailed Description. Provide in text the purpose of the trial.|
Principal Investigator (PI): Name of physician who has organizational and fiscal responsibility for the use of federal funds to conduct a clinical study.
View the handbook for clinical investigators (PDF).
Registration (as it pertains to CTRP trial) - 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: Protocol Registration System Information)
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: Approved; Active; Closed to Accrual; Temporarily Closed to Accrual and Intervention; Temporarily Closed to Accrual; Administratively Complete; Closed to Accrual and Intervention; Complete.
Trial type - Nature of the investigation that includes interventional, observational and expanded access studies (Source: Protocol Registration System Information)
Update - Updates are defined as \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, i.e, all changes to the protocol that do not fall into the definition of amendments.