Glossary of CTRP Terms
Terms [ A - D ] [ E - J ] [ K - O ] [ P - Z ] and Acronyms
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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.
Accrual submission (trial) - Collection of de-identified participant level data, with a focus on demographical information, that are associated with a particular trial/study by organizations providing information to the NCI Clinical Trials Reporting Office (CTRO).
Activation - In the CTRP, this term usually refers to the official start date of a trial determined as follows 1) the date of activation noted 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: http://prsinfo.clinicaltrials.gov/)
Arm description - A brief description of the arm (Source: http://prsinfo.clinicaltrials.gov/)
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 designed to be a comprehensive database of regularly updated information, including accrual, on all NCI-supported clinical trials. This comprehensive database of the entire NCI portfolio will help identify gaps in clinical research and duplicative studies, as well as facilitate effective clinical trial prioritization.
Clinical Trials Reporting Office (CTRO) - The functional unit within the NCI that performs the operational work of the Clinical Trials Reporting Program (CTRP)
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 - Characteristic or indicative of (e.g., a disease). (NCI Thesaurus)
Diagnostic procedure - Methods, procedures, and tests performed to diagnose disease, disordered function, or disability. (NCI Thesaurus)
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E - J Terms
Existing Trial - A trial that was open to accrual as of January 1, 2009 and has not been reported previously to CTRP. Trials that were open as of January 1, 2009 but closed to accrual any time after that date need to be reported.
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: http://prsinfo.clinicaltrials.gov/)
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.
A decomposition of a sample grant number follows:
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 at http://grants.nih.gov/grants/glossary.htm. |
Health services research - Protocol designed to evaluate the delivery, processes, management, organization or financing of health care. (Source: http://prsinfo.clinicaltrials.gov/) The integration of epidemiologic, sociological, economic, and other analytic sciences in the study of health services. Health services research is usually concerned with relationships between need, demand, supply, use, and outcome of health services. The aim of the research is evaluation, particularly in terms of structure, process, output, and outcome.
Investigational New Drug (IND) - A new drug or biological drug that is used in a clinical investigation. The term also includes a biological product that is used in vitro for diagnostic purposes.(NCI Thesaurus C49135).
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: http://prsinfo.clinicaltrials.gov/) A pre-clinical or clinical study in human beings in which individuals are assigned by an investigator based on a protocol to receive specific interventions. The individuals are then followed and biomedical and/or health outcomes are assessed. (NCI Thesaurus C16140).
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K - O Terms
Lead organization - The principal administrative organization responsible for the research conducted. [Source: NCI] C63409.
Lead organization trial identifier - One or more characters assigned by the organization providing oversight for the study which is used to identify, name, or characterize the protocol document.
New trial -A trial that opened to accrual on or after January 1, 2009 and has not been reported previously to CTRP.
Non-Proprietary - A trial with no contractual obligation that restricts sharing of 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.
Other (relative to lists) - Different than the one(s) previously specified or mentioned. (NCI Thesaurus C17649). Includes any other term not included in a list.
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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/).
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/). 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: http://prsinfo.clinicaltrials.gov/).
Phase I/II (trial) - For trials that are a combination of Phases 1 and 2.(Source: http://prsinfo.clinicaltrials.gov/).
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: http://prsinfo.clinicaltrials.gov/).
Phase II/III (trial) - For trials that are a combination of phases 2 and 3 (Source: http://prsinfo.clinicaltrials.gov/).
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: http://prsinfo.clinicaltrials.gov/).
Phase IV (trial) - Studies of FDA-approved drugs to delineate additional information including the drug's risks, benefits, and optimal use (Source: http://prsinfo.clinicaltrials.gov/).
Phase-N/A (trial) - For trials without phases (Source: http://prsinfo.clinicaltrials.gov/).
Primary Purpose: Reason for the protocol (Source: http://prsinfo.clinicaltrials.gov/). 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:
| Primary Purpose, Valid Values | Definition |
|---|---|
| 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. |
| 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 |
| Treatment | [CT.GOV] Protocol designed to evaluate one or more interventions for treating a disease, syndrome or condition |
Primary purpose: Summary 4 valid values:
| Primary Purpose, Valid Values | Definition |
|---|---|
| Ancillary | [Summary4] Auxiliary studies that are stimulated by, but are not a required part of, a main clinical trial/study, and that utilize patient or other resources of the main trial/study to generate information relevant to it. Ancillary studies included must be linked to an active trial or epidemiologic or other study and should include only patients accrued to that trial or study. Only studies that can be linked to individual patient or participant data should be reported |
| Correlative | [Summary 4] Laboratory based studies using specimens to assess cancer risk, clinical outcomes, response to therapies, etc. Only studies that can be linked to individual patient or participant data should be reported |
| Early Detection | [Summary 4] Clinical trials directly testing the efficacy of devices, techniques, procedures; or tests for earlier detection or diagnosis of efficacy of devices, techniques, procedures; or tests for earlier or more accurate detection or diagnosis of disease. |
| Epidemiologic | [Summary4] Studies among cancer patients and healthy populations that involve no intervention or alteration in the status of the participants, e.g., surveillance, risk assessment, outcome, environmental, and behavioral studies |
| Observational | [Summary 4] Studies among cancer patients and healthy populations that involve no intervention or alteration in the status of the participants, e.g., surveillance, risk assessment, outcome, environmental, and behavioral studies |
| Outcome | [Summary 4] Studies among cancer patients and healthy populations that involve no intervention or alteration in the status of the participants, e.g., surveillance, risk assessment, outcome, environmental, and behavioral studies |
Principal Investigator (PI): Person who is the head of a coop agreement or grant under which an investigation or series of investigations are being conducted. CDISC definition for Investigator: An individual who actually conducts a clinical investigation, i.e., under whose immediate direction the test article is administered or dispensed to, or used involving, a subject, or, in the event of an investigation conducted by a team of individuals, is the responsible leader of that team.
Proprietary: A trial with a contractual obligation that restricts sharing of the protocol document.
Registration ( as it pertains to CTRP trial) - Initial clinical trial profile data that a grantee and/or site provides to NCI's Clinical Trials Reporting Office (CTRO) as part of Clinical Trials Reporting Program (CTRP).
Responsible Party - The sponsor of the clinical trial (as defined in 21 CFR 50.3 or any successor regulation) or the principal investigator of such clinical trial if so designated by a sponsor, grantee, contractor, or awardee, so long as the principal investigator is responsible for conducting the trial, has access to and control over the data from the clinical trial, has the right to publish the results of the trial, and has the ability to meet all of the requirements for the submission of clinical trial information.
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). A process of active consideration of potential subjects for enrollment in a trial. [Source: NCI] C48262 Clinical studies testing the efficacy of devices, techniques, procedures, or tests for the purpose of detecting the presence of disease, usually before there are any symptoms.
Sponsor - Primary organization that oversees implementation of he study and is responsible for data analysis. [21 CFR 50.3] Sponsor means a person who initiates a clinical investigation, but who does not actually conduct the investigation, i.e., the test article is administered or dispensed to or used involving, a subject under the immediate direction of another individual. A person other than an individual (e.g., corporation or agency) that uses one or more of its own employees to conduct a clinical investigation it has initiated is considered to be a sponsor (not a sponsor-investigator), and the employees are considered to be investigators.
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 - Grantee and/or site who is supplying trial data to NCI's Clinical Trials Reporting Office (CTRO) as part of the 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: http://prsinfo.clinicaltrials.gov/) Clinical studies intended to improve the comfort and quality of life for the patient using drugs, nutritional, dietary, behavioral or other interventions. [Source: NCI] C71486.
Treatment - Protocol designed to evaluate one or more interventions for treating a disease, syndrome or condition. (Source: http://prsinfo.clinicaltrials.gov/.
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: http://prsinfo.clinicaltrials.gov/). May also represent an anticipated outcome for a clinical
Update - Updates are defined as other 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.
