Clinical Trials Reporting Program

Terms [ A - D ] [ E - J ] [ K - O ] [ P - Z ] and Acronyms

A - D Terms

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 as is 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.

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

Clinical Trials Reporting Program (CTRP) - the operational implementation of an initiative proposed by the Clinical Trial Working Group (CTWG), which is compromised of NCI policies and standard operating procedures, the staff in the Clinical Trials Reporting Office (CTRO) and supporting technologies (database & portals for registration, abstraction, accrual & report generation).

Clinical Trials Reporting Office (CTRO) - the functional unit within the NCI that performs the operational work of the Clinical Trials Reporting Program (CTRP)

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

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 NUH, which provide the monies for the trials or infrastructure associated with the research.

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 - A trial that has just received initial approval from the IRB and has not been reported previously

Observational trials/studies - Studies among cancer patients and healthy populations that involve no intervention or alteration in the status of the participants. [Source: NCI] C16084are 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) - NCI 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) - One in a set of successive stages in a progression or sequence such as:

1. A step in the progression of a therapy from initial experimental use in humans to post market evaluation.
2. A stage in the conduct of a clinical trial NOTE: Clinical trials are generally categorized into four (sometimes five) phases. A therapeutic intervention may be evaluated in two or more phases simultaneously in different trials, and some trials may overlap two different phases.
3. A distinguishable part, a stage in a series of events or in a process of development, e.g. any of the varying aspects or stages in course of a disease.

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/). A clinical trial that uses a treatment or investigational agent that is available only in very limited quantities and which has never previously been given to humans or for which there is extremely limited human experience. Phase 0 clinical trials are intended to enable researchers to understand the path of the drug in the body and its efficacy. Adverse event reporting in Phase 0 trials is expedited.

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/).

A class of clinical study that combines elements characteristic of traditional Phase I and Phase II trials. CDISC

Phase II (trial) - 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 associated with the drug. [After FDA CDER Handbook, ICH E8] (CDISC glossary)

A clinical research protocol designed to study a biomedical or behavioral intervention in a larger group of people (several hundred), to evaluate the drug's effectiveness for a particular indication in patients with the disease or condition under study, and to determine the common short-term side effects and risks associated with the intervention. (NCI Thesaurus C15601).

Phase II/III (trial) - A class of clinical study that combines elements characteristic of traditional Phase II and Phase III trials.

A type of clinical study that combines elements characteristic of traditional Phase II and Phase III trials.

Phase III (trial) - A clinical research protocol designed to investigate the efficacy of the biomedical or behavioral intervention in large groups of human subjects (from several hundred to several thousand), to confirm efficacy, to monitor adverse reactions to the new medication or treatment regimen with respect to long-term use and by comparing the intervention to other standard or experimental interventions as well as to a placebo. (NCI Thesaurus C15602)

Phase IV (trial) - Postmarketing (Phase 4) studies to delineate additional information about the drug's risks, benefits, and optimal use that may be requested by regulatory authorities in conjunction with marketing approval. NOTE: These studies could include, but would not be limited to, studying different doses or schedules of administration than were used in Phase 2 studies, use of the drug in other patient populations or other stages of the disease, or use of the drug over a longer period of time. [After FDA CDER Handbook, ICH E8] (CDISC glossary)

Phase-N/A (trial) - For trials without phases. (Source: http://prsinfo.clinicaltrials.gov/). The designation of a phase may not be applicable to all studies, such as observational.

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:

For summary IV, (please include a brief statement about what summary 4 is. Not everyone reading this glossary will be familiar with it. the valid values list includes the following:

• 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.

PROGRAM PI for the person who is the head of a coop agreement or grant under which an investigation or series of investigations are being conducted.

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 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.(Source: 21 CFR 50.3).

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.

Study type - nature of the investigation that includes interventional, observational and expanded access studies (Source: http://prsinfo.clinicaltrials.gov/).

Submitting organization - Grantee and/or site who is supplying 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. Trial status types are listed below:

Trial Type - Code to represent an anticipated outcome for a clinical trial or research study that is the meaning or purpose for actions taken, thus guiding planned actions (e.g. efficacy, safety).

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