Term IRI Term label Parent term IRI Parent term label Alternative term Definition http://purl.obolibrary.org/obo/IAO_0000005 objective specification http://purl.obolibrary.org/obo/IAO_0000033 directive information entity goal specification A directive information entity that describes an intended process endpoint. When part of a plan specification the concretization is realized in a planned process in which the bearer tries to effect the world so that the process endpoint is achieved. http://purl.obolibrary.org/obo/IAO_0000027 data item http://purl.obolibrary.org/obo/IAO_0000030 information content entity data a data item that is about the outcome measured by a clinical trial. http://purl.obolibrary.org/obo/IAO_0000300 textual entity http://purl.obolibrary.org/obo/IAO_0000030 information content entity text A textual entity is a part of a manifestation (FRBR sense), a generically dependent continuant whose concretizations are patterns of glyphs intended to be interpreted as words, formulas, etc. http://purl.obolibrary.org/obo/IAO_0000578 centrally registered identifier http://purl.obolibrary.org/obo/IAO_0000030 information content entity CRID An information content entity that consists of a CRID symbol and additional information about the CRID registry to which it belongs. http://purl.obolibrary.org/obo/OBI_0000070 assay http://purl.obolibrary.org/obo/OBI_0000011 planned process scientific observation A planned process with the objective to produce information about the material entity that is the evaluant, by physically examining it or its proxies. http://purl.obolibrary.org/obo/OBI_0000102 responsible party role http://purl.obolibrary.org/obo/OBI_0000202 investigation agent role responsible party a study personnel role played by a party who is accountable for the execution of a study component and can make decisions about the conduct of the study http://purl.obolibrary.org/obo/OBI_0000202 investigation agent role http://purl.obolibrary.org/obo/BFO_0000023 role investigator A role borne by an entity and that is realized in a process that is part of an investigation in which an objective is achieved. These processes include, among others: planning, overseeing, funding, reviewing. http://purl.obolibrary.org/obo/OBI_0000243 sponsor role http://purl.obolibrary.org/obo/OBI_0000102 responsible party role sponsor a responsible party role involved with any of the following activities: initiating, managing and funding a study http://purl.obolibrary.org/obo/OBI_0000968 device http://purl.obolibrary.org/obo/BFO_0000040 material_entity instrument A material entity that is designed to perform a function in a scientific investigation, but is not a reagent. http://purl.obolibrary.org/obo/OBI_0001755 selection criterion http://purl.obolibrary.org/obo/IAO_0000033 directive information entity selection rule A directive information entity which defines and states a principle of standard by which selection process may take place. http://purl.obolibrary.org/obo/OBI_0001928 selection http://purl.obolibrary.org/obo/OBI_0000011 planned process selection process A planned process which results in the creation of group of entity from a larger group by the application of predefined criteria. http://purl.obolibrary.org/obo/OBI_0500000 study design http://purl.obolibrary.org/obo/IAO_0000104 plan specification experimental design A plan specification comprised of protocols (which may specify how and what kinds of data will be gathered) that are executed as part of an investigation and is realized during a study design execution. http://purl.obolibrary.org/obo/OBI_0500006 parallel group design http://purl.obolibrary.org/obo/OBI_0500000 study design independent measure design A parallel group design or independent measure design is a study design which uses unique experimental unit each experimental group, in other word no two individuals are shared between experimental groups, hence also known as parallel group design. Subjects of a treatment group receive a unique combination of independent variable values making up a treatment http://purl.obolibrary.org/obo/OBI_0500026 eligibility criterion http://purl.obolibrary.org/obo/OBI_0001755 selection criterion eligibility rule The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex http://purl.obolibrary.org/obo/OBI_0500027 inclusion criterion http://purl.obolibrary.org/obo/OBI_0500026 eligibility criterion inclusion rule A type of eligibility criteria. These are the reasons that a person is allowed to participate in a clinical study. http://purl.obolibrary.org/obo/CTO_0000200 clinical trial primary purpose specification http://purl.obolibrary.org/obo/IAO_0000005 objective specification primary purpose of clinical trial The main objective of the intervention(s) being evaluated by the clinical trial. http://purl.obolibrary.org/obo/CTO_0000201 clinical trial phase http://purl.obolibrary.org/obo/PATO_0001236 process quality clinical trial stage The quality of a clinical trial that studies a drug or biological product. The phase is based on the study's objective, the number of participants, and other characteristics. According to USA FDA, there are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. http://purl.obolibrary.org/obo/CTO_0000202 clinical trial early phase 1 http://purl.obolibrary.org/obo/CTO_0000201 clinical trial phase Pre-Clinical Phase A clinical trial phase that is designed to use an investigational agent that is available only in very limited quantities and which has never previously 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. [def-source: NCI] http://purl.obolibrary.org/obo/CTO_0000203 clinical trial phase 1 http://purl.obolibrary.org/obo/CTO_0000201 clinical trial phase Phase I A clinical trial phase that represents the first-in-man trial, which tests within a small group of people (typically 20-80) to evaluate safety, determine safe dosage ranges, and begin to identify side effects. A drug's side effects could be subtle or long term, or may only happen with a few people, so phase 1 trials are not expected to identify all side effects. http://purl.obolibrary.org/obo/CTO_0000204 clinical trial phase 2 http://purl.obolibrary.org/obo/CTO_0000201 clinical trial phase Phase II A clinical trial phase that is 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. [def-source: NCI] http://purl.obolibrary.org/obo/CTO_0000205 clinical trial phase 3 http://purl.obolibrary.org/obo/CTO_0000201 clinical trial phase Phase III A clinical trial phase that is 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. [def-source: NCI] http://purl.obolibrary.org/obo/CTO_0000206 clinical trial phase 4 http://purl.obolibrary.org/obo/CTO_0000201 clinical trial phase Phase IV A clinical trial phase that is designed for a randomized, controlled trial to evaluate the long-term safety and efficacy of a drug for a given indication. Often they are designed to study side effects that may have become apparent after the phase III study was completed. [def-source: NCI] http://purl.obolibrary.org/obo/CTO_0000207 Early Phase 1 clinical trial http://purl.obolibrary.org/obo/CTO_0000220 clinical trial Phase 0 trial Exploratory trials, involving very limited human exposure, with no therapeutic or diagnostic intent (e.g., screening studies, microdose studies). (Formerly listed as "Phase 0") http://purl.obolibrary.org/obo/CTO_0000211 JMACCT clinical trial identifier http://purl.obolibrary.org/obo/CTO_0000209 Japan clinical trial identifier JMACCT A centrally registered identifier that is assigned for a specific clinical trial registered in JMACCT. The format for the JMACCT registry number is “JMA-IIA” followed by a 5-digit number, e.g., JMA-IIA00391. http://purl.obolibrary.org/obo/CTO_0000212 UMIN-CTR clinical trial identifier http://purl.obolibrary.org/obo/CTO_0000209 Japan clinical trial identifier UMIN A Japan clinical trial identifier provided by the University Hospital Medical Information Network Center (UMIN-CTR) http://purl.obolibrary.org/obo/CTO_0000213 USA National Clinical Trial identifier http://purl.obolibrary.org/obo/NCIT_C98714 Clinical Trial Registry Identifier National Clinical Trial identifier A centrally registered identifier that is assigned for a specific clinical trial registered in the ClinicalTrials.gov. The format for the ClinicalTrials.gov registry number is “NCT” followed by an 8-digit number, e.g.: NCT00000419. http://purl.obolibrary.org/obo/CTO_0000220 clinical trial http://purl.obolibrary.org/obo/NCIT_C98388 Interventional Study interventional trial a clinical trial is a medical interventional study where participants are assigned prospectively to an intervention or interventions according to a protocol to evaluate the safety and efficacy of the intervention(s) on biomedical or other health related outcomes. The Interventions include but are not restricted to drugs, cells and other biological products, surgical procedures, radiologic procedures, devices, behavioral treatments, process-of-care changes, preventive care, etc. http://purl.obolibrary.org/obo/CTO_0000132 pivotal clinical trial http://purl.obolibrary.org/obo/CTO_0000220 clinical trial pivotal trial A clinical trial is conducted for the purpose of demonstrating the efficacy of a new drug in order to obtain its marketing approval by regulatory authorities (e.g. FDA in the United States and EMA in Europe). The pivotal clinical trial usually is a Phase III clinical trial, but exceptionally phase 2 studies could also be utilized as pivotal trials. http://purl.obolibrary.org/obo/OAE_0000001 adverse event http://purl.obolibrary.org/obo/OGMS_0000061 pathological bodily process adverse reaction Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant’s participation in the research, whether or not considered related to the participant’s participation in the research http://purl.obolibrary.org/obo/OPMI_0000282 medical condition http://purl.obolibrary.org/obo/BFO_0000017 realizable entity medical state The medical state or condition of a patient http://purl.obolibrary.org/obo/OPMI_0000399 secondary sponsor role http://purl.obolibrary.org/obo/OBI_0000243 sponsor role collaborator role A sponsor role taken by an additional individual, organization or another legal person, if any, that has agreed with the primary sponsor to take on responsibilities of sponsorship. http://purl.obolibrary.org/obo/OPMI_0000402 investigation collaborator role http://purl.obolibrary.org/obo/OBI_0000202 investigation agent role collaborator role An investigation agent role taken by an agent (an individual, organization, group or another legal entity) who provides support to an investigation. The support may include funding, design, implementation, data analysis or reporting. The responsible party is responsible for confirming all collaborators before listing them. http://purl.obolibrary.org/obo/OPMI_0000390 investigator role http://purl.obolibrary.org/obo/OBI_0000202 investigation agent role human investigator role An investigation agent role that is taken by a human individual http://purl.obolibrary.org/obo/OPMI_0000395 central contact person of study http://purl.obolibrary.org/obo/OPMI_0000383 contact person central contact person A person to whom questions concerning enrollment at any location of the study can be addressed. http://purl.obolibrary.org/obo/OPMI_0000112 telephone number http://purl.obolibrary.org/obo/OPMI_0000397 contact person information phone number A telephone number is a sequence of digits assigned to a fixed-line telephone subscriber station connected to a telephone line or to a wireless electronic telephony device, such as a radio telephone or a mobile telephone, or to other devices for data transmission via the public switched telephone network (PSTN) or other public and private networks. http://purl.obolibrary.org/obo/OPMI_0000418 human subject study http://purl.obolibrary.org/obo/OBI_0000066 investigation human study A systematic, scientific investigation that can be either interventional or observational and involves human beings as research subjects. Human subject research can be either medical (clinical) research or non-medical (e.g., social science) research. http://purl.obolibrary.org/obo/CTO_0000022 Chinese clinical trail registry identifier http://purl.obolibrary.org/obo/NCIT_C98714 Clinical Trial Registry Identifier ChiCTR identifier A centrally registered identifier that is assigned for a specific clinical trial registered in the Chinese clinical trials register (ChiCTR). The format for the registry number is “ChiCTR” followed by a 10-digit number, e.g., ChiCTR2000031589. http://purl.obolibrary.org/obo/CHEBI_23367 molecular entity http://purl.obolibrary.org/obo/BFO_0000040 material_entity Any constitutionally or isotopically distinct atom, molecule, ion, ion pair, radical, radical ion, complex, conformer etc., identifiable as a separately distinguishable entity. http://purl.obolibrary.org/obo/CHEBI_24431 chemical entity http://purl.obolibrary.org/obo/BFO_0000040 material_entity A chemical entity is a physical entity of interest in chemistry including molecular entities, parts thereof, and chemical substances. http://purl.obolibrary.org/obo/MS_1000590 contact affiliation http://purl.obolibrary.org/obo/IAO_0000300 textual entity Home institution of the contact person. http://purl.obolibrary.org/obo/OAE_0000002 medical intervention http://purl.obolibrary.org/obo/OBI_0000011 planned process A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise. http://purl.obolibrary.org/obo/OAE_0000011 drug administration http://purl.obolibrary.org/obo/OAE_0000002 medical intervention a medical intervention where a patient is administered with a drug http://purl.obolibrary.org/obo/OAE_0000094 therapeutic intervention http://purl.obolibrary.org/obo/OAE_0000002 medical intervention a medical intervention that is used for therapeutic purpose http://purl.obolibrary.org/obo/OAE_0002807 medical procedure http://purl.obolibrary.org/obo/OAE_0000002 medical intervention a medical intervention that refers to any series of pre-defined steps that should be followed to achieve a desired result. http://purl.obolibrary.org/obo/OGMS_0000014 clinical finding http://purl.obolibrary.org/obo/IAO_0000027 data item A representation that is either the output of a clinical history taking or a physical examination or an image finding, or some combination thereof. http://purl.obolibrary.org/obo/PATO_0001236 process quality http://purl.obolibrary.org/obo/BFO_0000019 quality A quality which inheres in an process. http://purl.obolibrary.org/obo/PATO_0001241 physical object quality http://purl.obolibrary.org/obo/BFO_0000019 quality A quality which inheres in a continuant. http://purl.obolibrary.org/obo/PATO_0001894 phenotypic sex http://purl.obolibrary.org/obo/PATO_0000047 biological sex An organismal quality inhering in a bearer by virtue of the bearer's physical expression of sexual characteristics. http://purl.obolibrary.org/obo/NCIT_C15329 Surgical Procedure http://purl.obolibrary.org/obo/OAE_0002807 medical procedure A diagnostic or treatment procedure performed by manual and/or instrumental means, often involving an incision and the removal or replacement of a diseased organ or tissue; of or relating to or involving or used in surgery or requiring or amenable to treatment by surgery. http://purl.obolibrary.org/obo/NCIT_C115575 Clinical Trial Final Report http://purl.obolibrary.org/obo/IAO_0000088 report Records containing any interim or final results, as well as clinical and statistical descriptions, presentations, analyses and interpretations of any therapeutic, prophylactic, or diagnostic agent used in human subjects in a clinical trial. http://purl.obolibrary.org/obo/OBI_0002555 age group inclusion criterion http://purl.obolibrary.org/obo/OBI_0500027 inclusion criterion A type of eligibility criteria that indicates the age a person must be to participate in a clinical study. This may be indicated by a specific age or the following age groups. The age groups are: Child (birth-17), Adult (18-64), Older Adult (65+). http://purl.obolibrary.org/obo/OBI_0002556 minimum age value specification http://purl.obolibrary.org/obo/OBI_0001933 value specification The numerical value, if any, for the minimum age a potential participant must meet to be eligible for the clinical study. http://purl.obolibrary.org/obo/OBI_0002557 maximum age value specification http://purl.obolibrary.org/obo/OBI_0001933 value specification The numerical value, if any, for the maximum age a potential participant can be to be eligible for the clinical study. http://purl.obolibrary.org/obo/OBI_0002561 sex inclusion criterion http://purl.obolibrary.org/obo/OBI_0500027 inclusion criterion A type of eligibility criteria that indicates the sex of people who may participate in a clinical study (all, female, male). Sex is a person's classification as female or male based on biological distinctions. Sex is distinct from gender-based eligibility. http://purl.obolibrary.org/obo/NCIT_C147141 Study Primary Purpose http://purl.obolibrary.org/obo/IAO_0000104 plan specification The main objective of the intervention(s) being evaluated by the clinical trial. http://purl.obolibrary.org/obo/NCIT_C161319 Condition or Disease under Study http://purl.obolibrary.org/obo/OPMI_0000282 medical condition The name(s) of the disease(s) or condition(s) studied in the clinical study, or the focus of the clinical study. Use, if available, appropriate descriptors from NLM's Medical Subject Headings (MeSH)-controlled vocabulary thesaurus or terms from another vocabulary, such as the Systematized Nomenclature of Medicine—Clinical Terms (SNOMED CT), that has been mapped to MeSH within the Unified Medical Language System (UMLS) Metathesaurus. http://purl.obolibrary.org/obo/BFO_0000002 continuant http://purl.obolibrary.org/obo/BFO_0000001 entity An entity that exists in full at any time in which it exists at all, persists through time while maintaining its identity and has no temporal parts. http://purl.obolibrary.org/obo/BFO_0000004 independent continuant http://purl.obolibrary.org/obo/BFO_0000002 continuant b is an independent continuant = Def. b is a continuant which is such that there is no c and no t such that b s-depends_on c at t. (axiom label in BFO2 Reference: [017-002]) http://purl.obolibrary.org/obo/BFO_0000015 process http://purl.obolibrary.org/obo/BFO_0000003 occurrent An occurrent that has temporal proper parts and for some time t, p s-depends_on some material entity at t. http://purl.obolibrary.org/obo/BFO_0000017 realizable entity http://purl.obolibrary.org/obo/BFO_0000020 specifically dependent continuant A specifically dependent continuant that inheres in continuant entities and are not exhibited in full at every time in which it inheres in an entity or group of entities. The exhibition or actualization of a realizable entity is a particular manifestation, functioning or process that occurs under certain circumstances. http://purl.obolibrary.org/obo/BFO_0000020 specifically dependent continuant http://purl.obolibrary.org/obo/BFO_0000002 continuant b is a specifically dependent continuant = Def. b is a continuant & there is some independent continuant c which is not a spatial region and which is such that b s-depends_on c at every time t during the course of b’s existence. (axiom label in BFO2 Reference: [050-003]) http://purl.obolibrary.org/obo/BFO_0000023 role http://purl.obolibrary.org/obo/BFO_0000017 realizable entity A realizable entity the manifestation of which brings about some result or end that is not essential to a continuant in virtue of the kind of thing that it is but that can be served or participated in by that kind of continuant in some kinds of natural, social or institutional contexts. http://purl.obolibrary.org/obo/BFO_0000031 generically dependent continuant http://purl.obolibrary.org/obo/BFO_0000002 continuant A continuant that is dependent on one or other independent continuant bearers. For every instance of A requires some instance of (an independent continuant type) B but which instance of B serves can change from time to time. http://purl.obolibrary.org/obo/BFO_0000035 process boundary http://purl.obolibrary.org/obo/BFO_0000003 occurrent p is a process boundary =Def. p is a temporal part of a process & p has no proper temporal parts. (axiom label in BFO2 Reference: [084-001]) http://purl.obolibrary.org/obo/BFO_0000040 material_entity http://purl.obolibrary.org/obo/BFO_0000004 independent continuant An independent continuant that is spatially extended whose identity is independent of that of other entities and can be maintained through time. http://purl.obolibrary.org/obo/BFO_0000140 continuant fiat boundary http://purl.obolibrary.org/obo/BFO_0000141 immaterial entity b is a continuant fiat boundary = Def. b is an immaterial entity that is of zero, one or two dimensions and does not include a spatial region as part. (axiom label in BFO2 Reference: [029-001]) http://purl.obolibrary.org/obo/BFO_0000144 process profile http://purl.obolibrary.org/obo/BFO_0000015 process b is a process_profile =Def. there is some process c such that b process_profile_of c (axiom label in BFO2 Reference: [093-002]) http://purl.obolibrary.org/obo/BFO_0000145 relational quality http://purl.obolibrary.org/obo/BFO_0000019 quality b is a relational quality = Def. for some independent continuants c, d and for some time t: b quality_of c at t & b quality_of d at t. (axiom label in BFO2 Reference: [057-001]) http://purl.obolibrary.org/obo/IAO_0000007 action specification http://purl.obolibrary.org/obo/IAO_0000033 directive information entity A directive information entity that describes an action the bearer will take. http://purl.obolibrary.org/obo/IAO_0000030 information content entity http://purl.obolibrary.org/obo/BFO_0000031 generically dependent continuant An information content entity is an entity that is generically dependent on some artifact and stands in relation of aboutness to some entity http://purl.obolibrary.org/obo/IAO_0000033 directive information entity http://purl.obolibrary.org/obo/IAO_0000030 information content entity An information content entity whose concretizations indicate to their bearer how to realize them in a process. http://purl.obolibrary.org/obo/IAO_0000078 curation status specification http://purl.obolibrary.org/obo/IAO_0000102 data about an ontology part The curation status of the term. The allowed values come from an enumerated list of predefined terms. See the specification of these instances for more detailed definitions of each enumerated value. http://purl.obolibrary.org/obo/IAO_0000088 report http://purl.obolibrary.org/obo/IAO_0000310 document a document assembled by an author for the purpose of providing information for the audience. A report is the output of a documenting process and has the objective to be consumed by a specific audience. Topic of the report is on something that has completed. A report is not a single figure. Examples of reports are journal article, patent application, grant progress report, case report (not patient record) http://purl.obolibrary.org/obo/IAO_0000102 data about an ontology part http://purl.obolibrary.org/obo/IAO_0000027 data item data about an ontology part is a data item about a part of an ontology, for example a term http://purl.obolibrary.org/obo/IAO_0000104 plan specification http://purl.obolibrary.org/obo/IAO_0000033 directive information entity A directive information entity with action specifications and objective specifications as parts that, when concretized, is realized in a process in which the bearer tries to achieve the objectives by taking the actions specified. http://purl.obolibrary.org/obo/IAO_0000310 document http://purl.obolibrary.org/obo/IAO_0000030 information content entity A collection of information content entities intended to be understood together as a whole http://purl.obolibrary.org/obo/IAO_0000422 postal address http://purl.obolibrary.org/obo/IAO_0000300 textual entity A textual entity that is used as directive to deliver something to a person, or organization http://purl.obolibrary.org/obo/OBI_0000011 planned process http://purl.obolibrary.org/obo/BFO_0000015 process A processual entity that realizes a plan which is the concretization of a plan specification. http://purl.obolibrary.org/obo/OBI_0000066 investigation http://purl.obolibrary.org/obo/OBI_0000011 planned process a planned process that consists of parts: planning, study design execution, documentation and which produce conclusion(s). http://purl.obolibrary.org/obo/OBI_0000115 intervention design http://purl.obolibrary.org/obo/OBI_0500000 study design An intervention design is a study design in which a controlled process applied to the subjects (the intervention) serves as the independent variable manipulated by the experimentalist. The treatment (perturbation or intervention) defined can be defined as a combination of values taken by independent variable manipulated by the experimentalists are applied to the recruited subjects assigned (possibly by applying specific methods) to treatment groups. The specificity of intervention design is the fact that independent variables are being manipulated and a response of the biological system is evaluated via response variables as monitored by possibly a series of assays. http://purl.obolibrary.org/obo/OBI_0000245 organization http://purl.obolibrary.org/obo/BFO_0000040 material_entity An entity that can bear roles, has members, and has a set of organization rules. Members of organizations are either organizations themselves or individual people. Members can bear specific organization member roles that are determined in the organization rules. The organization rules also determine how decisions are made on behalf of the organization by the organization members. http://purl.obolibrary.org/obo/OBI_0000272 protocol http://purl.obolibrary.org/obo/IAO_0000104 plan specification A plan specification which has sufficient level of detail and quantitative information to communicate it between investigation agents, so that different investigation agents will reliably be able to independently reproduce the process. http://purl.obolibrary.org/obo/OBI_0000810 informed consent process http://purl.obolibrary.org/obo/OBI_0000011 planned process A planned process in which a person or their legal representative is informed about key facts about potential risks and benefits of a process and makes a documented decision as to whether the person in question will participate. http://purl.obolibrary.org/obo/OBI_0001627 country name http://purl.obolibrary.org/obo/IAO_0000300 textual entity A textual entity that denotes a geographic location that is a site or part of a site that is identified as a country in the political geography. http://purl.obolibrary.org/obo/OBI_0001933 value specification http://purl.obolibrary.org/obo/IAO_0000030 information content entity An information content entity that specifies a value within a classification scheme or on a quantitative scale. http://purl.obolibrary.org/obo/OBI_0300311 observation design http://purl.obolibrary.org/obo/OBI_0500000 study design observation design is a study design in which subjects are monitored in the absence of any active intervention by experimentalists. http://purl.obolibrary.org/obo/OBI_0500002 repeated measure design http://purl.obolibrary.org/obo/OBI_0000115 intervention design a study design which use the same individuals and exposure them to a set of conditions. The effect of order and practice can be confounding factor in such designs http://purl.obolibrary.org/obo/OBI_0500003 cross over design http://purl.obolibrary.org/obo/OBI_0500002 repeated measure design a repeated measure design which ensures that experimental units receive, in sequence, the treatment (or the control), and then, after a specified time interval (aka *wash-out periods*), switch to the control (or treatment). In this design, subjects (patients in human context) serve as their own controls, and randomization may be used to determine the ordering which a subject receives the treatment and control http://purl.obolibrary.org/obo/OBI_0500004 n-to-1 design http://purl.obolibrary.org/obo/OBI_0500003 cross over design N-of-1 design is a cross-over design in which the same patient is repeatedly randomised to receive either the experimental treatment or its control (Senn, 1993). http://purl.obolibrary.org/obo/OBI_0500014 factorial design http://purl.obolibrary.org/obo/OBI_0500000 study design factorial design is_a study design which is used to evaluate two or more factors simultaneously. The treatments are combinations of levels of the factors. The advantages of factorial designs over one-factor-at-a-time experiments is that they are more efficient and they allow interactions to be detected. In statistics, a factorial design experiment is an experiment whose design consists of two or more factors, each with discrete possible values or levels, and whose experimental units take on all possible combinations of these levels across all such factors. Such an experiment allows studying the effect of each factor on the response variable, as well as the effects of interactions between factors on the response variable. http://purl.obolibrary.org/obo/OBI_0500028 exclusion criterion http://purl.obolibrary.org/obo/OBI_0500026 eligibility criterion A type of eligibility criteria. These are reasons that a person is not allowed to participate in a clinical study. http://purl.obolibrary.org/obo/OBI_0600004 human subject enrollment http://purl.obolibrary.org/obo/OBI_0001928 selection A planned process with the objective to obtain a population of human subjects to participate in an investigation by determining eligibility of subjects and obtaining informed consent. http://purl.obolibrary.org/obo/OGMS_0000015 clinical history http://purl.obolibrary.org/obo/IAO_0000027 data item A series of statements representing health-relevant qualities of a patient and of a patient's family. http://purl.obolibrary.org/obo/OGMS_0000031 disease http://purl.obolibrary.org/obo/BFO_0000016 disposition A disposition (i) to undergo pathological processes that (ii) exists in an organism because of one or more disorders in that organism. http://purl.obolibrary.org/obo/PATO_0000047 biological sex http://purl.obolibrary.org/obo/PATO_0001995 organismal quality An organismal quality inhering in a bearer by virtue of the bearer's ability to undergo sexual reproduction in order to differentiate the individuals or types involved. http://purl.obolibrary.org/obo/PATO_0000383 female http://purl.obolibrary.org/obo/PATO_0001894 phenotypic sex A biological sex quality inhering in an individual or a population that only produces gametes that can be fertilised by male gametes. http://purl.obolibrary.org/obo/PATO_0000384 male http://purl.obolibrary.org/obo/PATO_0001894 phenotypic sex A biological sex quality inhering in an individual or a population whose sex organs contain only male gametes. http://purl.obolibrary.org/obo/PATO_0001995 organismal quality http://purl.obolibrary.org/obo/PATO_0001241 physical object quality A quality that inheres in an entire organism or part of an organism. http://purl.obolibrary.org/obo/VO_0000002 vaccination http://purl.obolibrary.org/obo/OAE_0000002 medical intervention a medical intervention that involves in adding vaccine into a host (e.g., human, mouse) in vivo with the intent to invoke an adaptive immune response. http://purl.obolibrary.org/obo/OMIABIS_0001019 longitudinal study design http://purl.obolibrary.org/obo/OBI_0500000 study design A study design that involves repeated observations of the same entity over time. In the biobank context, longitudinal studies sample a group of people in a given time period, and study them at intervals by the acquisition and analyses of data and/or samples over time. http://purl.obolibrary.org/obo/OMIABIS_0001020 cohort study design http://purl.obolibrary.org/obo/OMIABIS_0001019 longitudinal study design A longitudinal study that aims to study a case-defined population who presently have a certain condition or recepient of a particular treatment that are followed over time and are compared with a similar group who do not have condition. http://purl.obolibrary.org/obo/OMRSE_00000024 role in human social processes http://purl.obolibrary.org/obo/BFO_0000023 role A role inhering in an entity realized by social interactions in human society. http://purl.obolibrary.org/obo/OMRSE_00000038 legal person role http://purl.obolibrary.org/obo/OMRSE_00000024 role in human social processes A role borne by a human individual or by a collection of humans regarded as possessing rights and duties enforeable at law. http://purl.obolibrary.org/obo/NCIT_C70817 Study Protocol http://purl.obolibrary.org/obo/OBI_0000272 protocol The written description of the clinical study, including objective(s), design, and methods. It may also include relevant scientific background and statistical considerations (if the protocol document includes the statistical analysis plan, use "Study Protocol with SAP and/or ICF" option). Note: All amendments approved by a human subjects protection review board (if applicable), before the time of submission and that apply to all clinical trial Facility Locations must be included. http://purl.obolibrary.org/obo/CTO_0000214 study start date http://purl.obolibrary.org/obo/BFO_0000148 zero-dimensional temporal region The date on which a study starts http://purl.obolibrary.org/obo/CTO_0000215 clinical trial primary completion date http://purl.obolibrary.org/obo/OPMI_0000297 study completion date The date that the final participant was examined or received an intervention for the purposes of final collection of data for the primary outcome, whether the clinical study concluded according to the pre-specified protocol or was terminated. In the case of clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all of the primary outcomes. http://purl.obolibrary.org/obo/CTO_0000216 clinical trial study completion date http://purl.obolibrary.org/obo/OPMI_0000297 study completion date The date the final participant was examined or received an intervention for purposes of final collection of data for the primary and secondary outcome measures and adverse events (for example, last participant’s last visit), whether the clinical study concluded according to the pre-specified protocol or was terminated. http://purl.obolibrary.org/obo/CTO_0000217 title of clinical trial http://purl.obolibrary.org/obo/IAO_0000300 textual entity A textual entity that is the title of a clinical trial http://purl.obolibrary.org/obo/CTO_0000218 lay title of clinical trial http://purl.obolibrary.org/obo/CTO_0000217 title of clinical trial A title of clinical trial that is meant for lay people understanding http://purl.obolibrary.org/obo/CTO_0000219 official title of clinical trial http://purl.obolibrary.org/obo/CTO_0000217 title of clinical trial A title of clinical trial that is recorded as official http://purl.obolibrary.org/obo/DRON_00000005 drug product http://purl.obolibrary.org/obo/BFO_0000040 material_entity a material entity (1) containing at least one scattered molecular aggregate as part that is the bearer of an active ingredient role and (2) that is itself the bearer of a clinical drug role http://purl.obolibrary.org/obo/OGMS_0000061 pathological bodily process http://purl.obolibrary.org/obo/OGMS_0000060 bodily process A bodily process that is clinically abnormal. http://purl.obolibrary.org/obo/PDRO_0000129 condition http://purl.obolibrary.org/obo/IAO_0000030 information content entity An information content entity that describes some relationships between some entities and whose truthfullness is a prerequisite for something. http://purl.obolibrary.org/obo/VO_0000427 phase 1 vaccine trial http://purl.obolibrary.org/obo/VO_0000596 vaccine clinical trial A vaccine clinical trial that investigates the safety profile of a vaccine in a small group (10-50) of healthy volunteers. http://purl.obolibrary.org/obo/VO_0000428 phase 2 vaccine trial http://purl.obolibrary.org/obo/VO_0000596 vaccine clinical trial A vaccine clinical trial that studies vaccine efficacy with a target population (numbering 50-100). Different dosage levels will also be explored at this stage to determine the optimum dose. http://purl.obolibrary.org/obo/VO_0000429 phase 3 vaccine trial http://purl.obolibrary.org/obo/VO_0000596 vaccine clinical trial A vaccine clinical trial that takes the trial to a large-scale safety and efficacy study in a relevant patient population, usually in excess of 3,000. http://purl.obolibrary.org/obo/VO_0000430 phase 4 vaccine trial http://purl.obolibrary.org/obo/VO_0000596 vaccine clinical trial The final stage of vaccine clinical evaluation. Phase IV occurs after a vaccine or therapy is licensed and is being used by large numbers of people. These studies are not always required or completed. http://purl.obolibrary.org/obo/VO_0000596 vaccine clinical trial http://purl.obolibrary.org/obo/CTO_0000220 clinical trial A processual entity by which a vaccine is tested clinically for safety and effectiveness. Clinical trials are conducted in phases. Classically, clinical trials unfold in three phases in order to gather data and information about a vaccine and its performance. This will form the basis of a dossier submitted to regulatory authorities by way of an application for licensure. After a vaccine is licensed and is being used by large numbers of people, a Phase IV study may or may not be taken for vaccine clinical evaluation. http://purl.obolibrary.org/obo/NCIT_C25150 Age http://purl.obolibrary.org/obo/NCIT_C19332 Personal Attribute A type of eligibility criteria that indicates the age a person must be to participate in a clinical study. http://purl.obolibrary.org/obo/NCIT_C70793 Clinical Study Sponsor http://purl.obolibrary.org/obo/NCIT_C48355 Sponsor An entity such as an individual, company, institution, group, or organization which takes responsibility for the initiation, management, and/or financing of a clinical study. The sponsor does not actually conduct the investigation unless the sponsor is a sponsor-investigator. A person other than an individual (e.g., corporation or agency) that uses one or more of its own employees to conduct research it has initiated is considered to be a sponsor, and the employees are considered to be investigators. [21 CFR P.50.3(k)] [21 CFR P.50.102(j)] [21 CFR P.312.3] http://purl.obolibrary.org/obo/NCIT_C70840 Blinded Clinical Study http://purl.obolibrary.org/obo/NCIT_C98388 Interventional Study A clinical study that is designed using a procedure in which one or more parties to the study [subject(s), investigator(s), monitor, or/and data analyst(s)] are kept unaware of the treatment assignment(s). http://purl.obolibrary.org/obo/NCIT_C71485 Screening Study http://purl.obolibrary.org/obo/NCIT_C147141 Study Primary Purpose One or more interventions are assessed or examined for identifying a condition, or risk factors for a condition, in people who are not yet known to have the condition or risk factor. http://purl.obolibrary.org/obo/NCIT_C71486 Supportive Care Study http://purl.obolibrary.org/obo/NCIT_C147141 Study Primary Purpose One or more interventions are evaluated for maximizing comfort, minimizing side effects, or mitigating against a decline in the participant's health or function. http://purl.obolibrary.org/obo/NCIT_C93360 Study Condition http://purl.obolibrary.org/obo/PDRO_0000129 condition A condition that is a focus of the study. http://purl.obolibrary.org/obo/NCIT_C142660 Random Allocation http://purl.obolibrary.org/obo/NCIT_C52580 Allocation Participants are assigned to intervention groups by chance http://purl.obolibrary.org/obo/OPMI_0000223 contact name http://purl.obolibrary.org/obo/NCIT_C60776 Contact Information The textual name of the contact person or organization http://purl.obolibrary.org/obo/OPMI_0000398 primary sponsor role http://purl.obolibrary.org/obo/OBI_0000243 sponsor role A sponsor role taken by an individual, organization, group or other legal entity which takes responsibility for initiating, managing and/or financing a study. The Primary Sponsor is responsible for ensuring that the trial is properly registered. The Primary Sponsor may or may not be the main funder. http://purl.obolibrary.org/obo/OPMI_0000400 principal investigator role http://purl.obolibrary.org/obo/OPMI_0000390 investigator role An investigator role taken by an individual who is designated as responsible party by the sponsor http://purl.obolibrary.org/obo/OPMI_0000401 sponsor investigator role http://purl.obolibrary.org/obo/OPMI_0000390 investigator role An investigator role taken by an individual who both initiates and conducts the study http://purl.obolibrary.org/obo/NCIT_C129000 Patient Registry Study http://purl.obolibrary.org/obo/NCIT_C16084 Observational Study An observational study that is also considered to be a Patient Registry. This type of study should only be registered once in the Protocol Registration and Results System (PRS), by the sponsor responsible for the primary data collection and analysis. http://purl.obolibrary.org/obo/NCIT_C16084 Observational Study http://purl.obolibrary.org/obo/OPMI_0000418 human subject study Studies among cancer patients and healthy populations that involve no intervention or alteration in the status of the participants. http://purl.obolibrary.org/obo/NCIT_C25320 Clinical Study Protocol http://purl.obolibrary.org/obo/NCIT_C70817 Study Protocol A formal document that describes a complete plan of research activity in the framework of a clinical study; specifically, the study objective(s), design, methodology, eligibility requests for prospective subjects and controls; intervention regimen(s), proposed methods of analysis of data; statistical considerations, and organization of the study. The protocol usually also provides the background and rationale for the trial, but these could be represented in other protocol referenced documents. http://purl.obolibrary.org/obo/OGMS_0000019 preclinical finding http://purl.obolibrary.org/obo/IAO_0000027 data item A representation of a quality of a patient that is (1) recorded by a clinician because the quality is hypothesized to be of clinical significance and (2) refers to qualities obtaining in the patient prior to their becoming detectable in a clinical history taking or physical examination. http://purl.obolibrary.org/obo/NCIT_C142175 Study Type http://purl.obolibrary.org/obo/OBI_0000011 planned process The nature of the investigation or the investigational use for which clinical study is being done. http://purl.obolibrary.org/obo/ERO_0000017 epidemiological study http://purl.obolibrary.org/obo/OPMI_0000418 human subject study A human study of diseases in populations of humans or other animals, specifically how, when and where they occur. Epidemiological studies can never prove causation, epidemiological evidence can only show that this risk factor is correlated with a higher incidence of disease in the population exposed to that risk factor. The higher the correlation the more certain the association, but it cannot prove the causation. http://purl.obolibrary.org/obo/ERO_0001092 medical device http://purl.obolibrary.org/obo/BFO_0000040 material_entity An instrument used in the diagnosis of disease or other conditions or for use in the care, treatment, or prevention of disease that does not achieve any of its primary intended purposes by chemical action or by being metabolized. http://purl.obolibrary.org/obo/ERO_0001402 feasibility study http://purl.obolibrary.org/obo/OPMI_0000418 human subject study A preliminary study to determine the practicability of a proposed health program or procedure or of a larger study and to appraise the factors that may influence its practicability. A feasibility study aims to discover those things which may affect successful study conduct on a larger scale. http://purl.obolibrary.org/obo/ERO_0001843 registry http://purl.obolibrary.org/obo/OBI_0000245 organization An organization dedicated to the collection, storage and dissemination of a set of scientific or clinical data. http://purl.obolibrary.org/obo/OGMS_0000073 diagnosis http://purl.obolibrary.org/obo/IAO_0000027 data item 1. the determination of the nature of a case of disease. 2. the art of distinguishing one disease from another. http://purl.obolibrary.org/obo/NCIT_C49653 Diagnosis Study http://purl.obolibrary.org/obo/NCIT_C147141 Study Primary Purpose One or more interventions are being evaluated for identifying a disease or health condition. http://purl.obolibrary.org/obo/NCIT_C49692 Planned Subject Number http://purl.obolibrary.org/obo/IAO_0000027 data item The number of subjects entered in a clinical trial. http://purl.obolibrary.org/obo/NCIT_C52580 Allocation http://purl.obolibrary.org/obo/OBI_0000115 intervention design The method by which participants are assigned to arms in a clinical trial. http://purl.obolibrary.org/obo/NCIT_C139174 Device Feasibility Study http://purl.obolibrary.org/obo/ERO_0001402 feasibility study An intervention of a device product is being evaluated to determine the feasibility of the product or to test a prototype device and not health outcomes. Such studies are conducted to confirm the design and operating specifications of a device before beginning a full clinical trial. (ClinicalTrials.gov) http://purl.obolibrary.org/obo/OBI_0002624 case-control study design http://purl.obolibrary.org/obo/OBI_0500000 study design A study design that entails the creation of two types of roles, such that each participant under investigation bears one or the other. What distinguishes the two types of roles is an 'outcome', which is associated with participants that have the case role but not associated with participants that have the control role. A case-control study examines the hypothesis that the presence of the outcome in case participants is associated with an 'exposure' that is not associated with control participants. http://purl.obolibrary.org/obo/NCIT_C19332 Personal Attribute http://purl.obolibrary.org/obo/IAO_0000030 information content entity The distinguishing qualities or prominent aspects of an individual person. http://purl.obolibrary.org/obo/NCIT_C15238 Gene Therapy http://purl.obolibrary.org/obo/OAE_0000002 medical intervention Application of genetic material (usually DNA) into cells in order to permanently correct an inherited disease or acquired disease. http://purl.obolibrary.org/obo/NCIT_C15245 Health Services Research http://purl.obolibrary.org/obo/NCIT_C147141 Study Primary Purpose One or more interventions for evaluating the delivery, processes, management, organization, or financing of healthcare. http://purl.obolibrary.org/obo/NCIT_C15600 Phase I Trial http://purl.obolibrary.org/obo/CTO_0000220 clinical trial Includes initial studies to determine the metabolism and pharmacologic actions of drugs in humans, the side effects associated with increasing doses, and to gain early evidence of effectiveness; may include healthy participants and/or patients. http://purl.obolibrary.org/obo/NCIT_C15601 Phase II Trial http://purl.obolibrary.org/obo/CTO_0000220 clinical trial Includes controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in participants with the disease or condition under study and to determine the common short-term side effects and risks. http://purl.obolibrary.org/obo/NCIT_C15602 Phase III Trial http://purl.obolibrary.org/obo/CTO_0000220 clinical trial Includes trials conducted 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. http://purl.obolibrary.org/obo/NCIT_C15603 Phase IV Trial http://purl.obolibrary.org/obo/CTO_0000220 clinical trial Studies of FDA-approved drugs to delineate additional information including the drug's risks, benefits, and optimal use. http://purl.obolibrary.org/obo/NCIT_C15693 Phase I/II Trial http://purl.obolibrary.org/obo/CTO_0000220 clinical trial Trials that are a combination of phases 1 and 2. http://purl.obolibrary.org/obo/NCIT_C15694 Phase II/III Trial http://purl.obolibrary.org/obo/CTO_0000220 clinical trial Trials that are a combination of phases 2 and 3. http://purl.obolibrary.org/obo/NCIT_C15714 Basic Research http://purl.obolibrary.org/obo/NCIT_C147141 Study Primary Purpose One or more interventions for examining the basic mechanism of action (for example, physiology or biomechanics of an intervention). http://purl.obolibrary.org/obo/NCIT_C49656 Treatment Study http://purl.obolibrary.org/obo/NCIT_C147141 Study Primary Purpose One or more interventions are being evaluated for treating a disease, syndrome, or condition. http://purl.obolibrary.org/obo/NCIT_C49657 Prevention Study http://purl.obolibrary.org/obo/NCIT_C147141 Study Primary Purpose One or more interventions are being assessed for preventing the development of a specific disease or health condition. http://purl.obolibrary.org/obo/NCIT_C48355 Sponsor http://purl.obolibrary.org/obo/NCBITaxon_9606 Homo sapiens A person or organization that supports or champions something. http://purl.obolibrary.org/obo/NCIT_C82638 Factorial Study http://purl.obolibrary.org/obo/NCIT_C98388 Interventional Study Two or more interventions, each alone and in combination, are evaluated in parallel against a control group http://purl.obolibrary.org/obo/NCIT_C84336 Collaborator http://purl.obolibrary.org/obo/NCBITaxon_9606 Homo sapiens Any of two or more parties working jointly towards a common goal. http://purl.obolibrary.org/obo/OPMI_0000383 contact person http://purl.obolibrary.org/obo/NCBITaxon_9606 Homo sapiens A person who serves as a contact role and has disclosed specified information to be reached. Usually the contact information, such as email and phone number, is provided., http://purl.obolibrary.org/obo/OPMI_0000384 facility contact http://purl.obolibrary.org/obo/OPMI_0000383 contact person A contact person for each facility participating in a study. http://purl.obolibrary.org/obo/OPMI_0000391 contact person role http://purl.obolibrary.org/obo/BFO_0000023 role a role taken by a person who serves as a contact for some process. http://purl.obolibrary.org/obo/OPMI_0000397 contact person information http://purl.obolibrary.org/obo/IAO_0000030 information content entity information content entity about a contact person http://purl.obolibrary.org/obo/NCIT_C98388 Interventional Study http://purl.obolibrary.org/obo/OPMI_0000418 human subject study Studies in which individuals are assigned by an investigator based on a protocol to receive specific interventions. Subjects may receive diagnostic, therapeutic or other types of interventions. The assignment of the intervention may or may not be random. The individuals are then followed and biomedical and/or health outcomes are assessed. http://purl.obolibrary.org/obo/NCIT_C98714 Clinical Trial Registry Identifier http://purl.obolibrary.org/obo/IAO_0000578 centrally registered identifier A sequence of letters, numbers, or other characters that uniquely identifies a clinical trial within a clinical trial registry. http://purl.obolibrary.org/obo/NCIT_C98722 Expanded Access Study http://purl.obolibrary.org/obo/OPMI_0000418 human subject study Studies that provide a means 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, or who are otherwise unable to participate in another clinical study. Expanded Access studies include individual-patient IND, treatment IND, compassionate use, emergency use or continued access. http://purl.obolibrary.org/obo/NCIT_C98747 Intervention Type http://purl.obolibrary.org/obo/OBI_0000011 planned process For each intervention studied in the clinical study, the general type of intervention. http://purl.obolibrary.org/obo/NCIT_C98772 Primary Outcome Measure http://purl.obolibrary.org/obo/CTO_0000104 outcome measurement datum The primary measurement(s) or observation(s) used to measure the effect of experimental variables in a study, or for observational studies, to describe patterns of diseases or traits or associations with exposures, risk factors or treatment. These are the outcome measures used to assess the primary objective(s). http://purl.obolibrary.org/obo/NCIT_C98781 Secondary Outcome Measure http://purl.obolibrary.org/obo/CTO_0000104 outcome measurement datum Other key measures that will be used to evaluate the intervention(s) or, for observational studies, that are a focus of the study. These are the outcome measures used to assess the secondary objective(s). http://purl.obolibrary.org/obo/OPMI_0000365 combinational intervention http://purl.obolibrary.org/obo/OAE_0000002 medical intervention Combining a drug and device, a biological product and device; a drug and biological product; or a drug, biological product, and device http://purl.obolibrary.org/obo/OPMI_0000293 investigator http://purl.obolibrary.org/obo/NCBITaxon_9606 Homo sapiens A person who performs an investigation task and takes the role of an investigator role. http://purl.obolibrary.org/obo/OPMI_0000294 clinical investigator http://purl.obolibrary.org/obo/OPMI_0000293 investigator An investigator who is involved in a clinical trial and is responsible for ensuring that an investigation is conducted according to the signed investigator statement, the investigational plan, and applicable regulations; for protecting the rights, safety, and welfare of subjects under the investigator's care; and for the control of drugs under investigation. http://purl.obolibrary.org/obo/OPMI_0000296 clinical trial start date http://purl.obolibrary.org/obo/CTO_0000214 study start date The (estimated) date on which the clinical study is open for recruitment of participants, or the actual date on which the first participant is enrolled. http://purl.obolibrary.org/obo/OPMI_0000297 study completion date http://purl.obolibrary.org/obo/BFO_0000148 zero-dimensional temporal region The date on which a study completes http://purl.obolibrary.org/obo/OPMI_0000302 date of registration http://purl.obolibrary.org/obo/BFO_0000148 zero-dimensional temporal region The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date). http://purl.obolibrary.org/obo/OPMI_0000304 recruitment status http://purl.obolibrary.org/obo/OPMI_0000326 status The recruitment status for the clinical study as a whole, based upon the status of the individual sites. If at least one facility in a multi-site clinical study has an Individual Site Status of "Recruiting," then the Overall Recruitment Status for the study must be "Recruiting." http://purl.obolibrary.org/obo/OPMI_0000327 study status http://purl.obolibrary.org/obo/OPMI_0000326 status The current stage of a clinical study and whether it is or will be open for enrollment http://purl.obolibrary.org/obo/OPMI_0000376 behavioral intervention http://purl.obolibrary.org/obo/OAE_0000002 medical intervention A medical intervention that involves a behavioral process to control, prevent, or treat a behavior problem. http://purl.obolibrary.org/obo/NCIT_C60776 Contact Information http://purl.obolibrary.org/obo/IAO_0000300 textual entity Information regarding the means of contacting a person or group. http://purl.obolibrary.org/obo/NCIT_C90467 Test Facility Country http://purl.obolibrary.org/obo/NCIT_C60776 Contact Information The country in which the test is conducted. http://purl.obolibrary.org/obo/NCIT_C90469 Test Facility Name http://purl.obolibrary.org/obo/NCIT_C60776 Contact Information The name of the place in which a test is conducted. http://purl.obolibrary.org/obo/CTO_0000001 secondary identifier http://purl.obolibrary.org/obo/IAO_0000030 information content entity An identifier(s) (ID), if any, other than the organization's Unique Protocol Identification Number or the NCT number that is assigned to the clinical study. This includes any unique clinical study identifiers assigned by other publicly available clinical trial registries. If the clinical study is funded in whole or in part by a U.S. Federal Government agency, the complete grant or contract number must be submitted as a Secondary ID. http://purl.obolibrary.org/obo/CTO_0000002 Australian New Zealand clinical trials registry identifier http://purl.obolibrary.org/obo/NCIT_C98714 Clinical Trial Registry Identifier A centrally registered identifier that is assigned for a specific clinical trial registered in the Australian New Zealand clinical trials registry (ANZCTR). The format for the registry number is “ACTRN” followed by a 14-digit number, e.g., ACTRN12620000457943. http://purl.obolibrary.org/obo/CTO_0000003 Australian New Zealand clinical trials registry http://purl.obolibrary.org/obo/CTO_0000073 primary registry Australian New Zealand Clinical Trials Registry is a primary clinical trial registry recognised by WHO and ICMJE that enables the registration of clinical trials. http://purl.obolibrary.org/obo/CTO_0000004 Peruvian clinical trial registry identifier http://purl.obolibrary.org/obo/NCIT_C98714 Clinical Trial Registry Identifier A centrally registered identifier that is assigned for a specific clinical trial registered in the Peruvian clinical trial registry (REPEC). The format for the registry number is “PER-” followed by a 3-digit number, followed by a hyphen, followed by a 2-digit number e.g., PER-010-20. http://purl.obolibrary.org/obo/CTO_0000005 masking design http://purl.obolibrary.org/obo/OBI_0500000 study design The party or parties involved in the clinical trial who are prevented from having knowledge of the interventions assigned to individual participants. http://purl.obolibrary.org/obo/CTO_0000006 non-random allocation http://purl.obolibrary.org/obo/NCIT_C52580 Allocation Participants are expressly assigned to intervention groups through a non-random method, such as physician choice http://purl.obolibrary.org/obo/CTO_0000007 study summary result http://purl.obolibrary.org/obo/IAO_0000088 report A study record that includes the summary results posted in the ClinicalTrials.gov results database. Summary results information includes participant flow, baseline characteristics, outcome measures, and adverse events (including serious adverse events). http://purl.obolibrary.org/obo/CTO_0000008 secondary outcome measure information http://purl.obolibrary.org/obo/CTO_0000051 outcome specification A description of each secondary outcome measure (or for observational studies, specific secondary measurement[s] or observation[s] used to describe patterns of diseases or traits or associations with exposures, risk factors or treatment). Each secondary outcome measure information includes title, description and time frame. http://purl.obolibrary.org/obo/CTO_0000009 Iranian registry of clinical trials http://purl.obolibrary.org/obo/CTO_0000073 primary registry The Iranian registry of clinical trials is a primary clinical trial registry recognised by WHO and ICMJE that enables the registration of clinical trials. http://purl.obolibrary.org/obo/CTO_0000010 other outcome measure information http://purl.obolibrary.org/obo/CTO_0000051 outcome specification Any other measurements, excluding post-hoc measures, that will be used to evaluate the intervention(s) or, for observational studies, that are a focus of the study. Each primary outcome measure information includes title, description and time frame. http://purl.obolibrary.org/obo/CTO_0000011 Indian clinical trials registry http://purl.obolibrary.org/obo/CTO_0000073 primary registry The Indian clinical trials registry is a primary clinical trial registry recognised by WHO and ICMJE that enables the registration of clinical trials. http://purl.obolibrary.org/obo/CTO_0000012 The Netherlands national trial register http://purl.obolibrary.org/obo/CTO_0000073 primary registry The Netherlands national trial register is a primary clinical trial registry recognised by WHO and ICMJE that enables the registration of clinical trials. http://purl.obolibrary.org/obo/CTO_0000013 Iranian registry of clinical trials identifier http://purl.obolibrary.org/obo/NCIT_C98714 Clinical Trial Registry Identifier A centrally registered identifier that is assigned for a specific clinical trial registered in the Iranian registry of clinical trials (IRCT). The format for the registry number is “IRCT” followed by a 14-digit number, one letter and again one or two numbers, e.g., IRCT20100228003449N29. http://purl.obolibrary.org/obo/CTO_0000014 German clinical trials register identifier http://purl.obolibrary.org/obo/NCIT_C98714 Clinical Trial Registry Identifier A centrally registered identifier that is assigned for a specific clinical trial registered in the German clinical trials register (DRKS). The format for the registry number is “DRKS” followed by a 8-digit number, e.g., DRKS00000494. http://purl.obolibrary.org/obo/CTO_0000015 Cuban public registry of clinical trials http://purl.obolibrary.org/obo/CTO_0000073 primary registry The Cuban public registry of clinical trials is a primary clinical trial registry recognised by WHO and ICMJE that enables the registration of clinical trials. http://purl.obolibrary.org/obo/CTO_0000016 clinical trial outcome measurement http://purl.obolibrary.org/obo/OBI_0000070 assay For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure. http://purl.obolibrary.org/obo/CTO_0000017 Pan African clinical trial registry http://purl.obolibrary.org/obo/CTO_0000073 primary registry The Pan African clinical trial registry is a primary clinical trial registry recognised by WHO and ICMJE that enables the registration of clinical trials. http://purl.obolibrary.org/obo/CTO_0000018 The Netherlands national trial register identifier http://purl.obolibrary.org/obo/NCIT_C98714 Clinical Trial Registry Identifier A centrally registered identifier that is assigned for a specific clinical trial registered in the The Netherlands national trial register (NTR). The format for the registry number is “NTR” followed by a 1 to 4-digit number, e.g., NL8498. http://purl.obolibrary.org/obo/CTO_0000019 JAPIC clinical trials registry http://purl.obolibrary.org/obo/CTO_0000073 primary registry The JAPIC (Japan Pharmaceutical Information Center) clinical trials registry is a primary clinical trial registry recognised by WHO and ICMJE that enables the registration of clinical trials. http://purl.obolibrary.org/obo/CTO_0000020 Pan African clinical trial registry identifier http://purl.obolibrary.org/obo/NCIT_C98714 Clinical Trial Registry Identifier A centrally registered identifier that is assigned for a specific clinical trial registered in the Pan African clinical trial register. The format for the registry number is “KCT” followed by a 15-digit number, e.g., PACTR202004893013257. http://purl.obolibrary.org/obo/CTO_0000023 Lebanese clinical trials registry http://purl.obolibrary.org/obo/CTO_0000073 primary registry The Lebanese clinical trials registry is a primary clinical trial registry recognised by WHO and ICMJE that enables the registration of clinical trials. http://purl.obolibrary.org/obo/CTO_0000024 German clinical trials register http://purl.obolibrary.org/obo/CTO_0000073 primary registry German clinical trials register is a primary clinical trial registry recognised by WHO and ICMJE that enables the registration of clinical trials. http://purl.obolibrary.org/obo/CTO_0000025 JMACCT clinical trials registry http://purl.obolibrary.org/obo/CTO_0000073 primary registry The JMACCT (Japan Medical Association, Center for Clinical Trials) clinical trials registry is a primary clinical trial registry recognised by WHO and ICMJE that enables the registration of clinical trials. http://purl.obolibrary.org/obo/CTO_0000028 number of participants http://purl.obolibrary.org/obo/IAO_0000027 data item The actual total number of participants that are enrolled in a clinical study http://purl.obolibrary.org/obo/CTO_0000030 Brazilian clinical trial registry identifier http://purl.obolibrary.org/obo/NCIT_C98714 Clinical Trial Registry Identifier A centrally registered identifier that is assigned for a specific clinical trial registered in Brazilian Registry of Clinical Trials (ReBEC). The format for the ReBEC registry number is “RBR-” followed by 6 characters, e.g., RBR-4hb9qs. http://purl.obolibrary.org/obo/CTO_0000031 clinical trial phase 2/3 http://purl.obolibrary.org/obo/CTO_0000201 clinical trial phase Clinical trial phase that is a combination of phases 2 and 3. http://purl.obolibrary.org/obo/CTO_0000032 study result http://purl.obolibrary.org/obo/IAO_0000027 data item data item .... http://purl.obolibrary.org/obo/CTO_0000033 healthy volunteer criterion http://purl.obolibrary.org/obo/OBI_0500027 inclusion criterion Indication that participants who do not have a disease or condition, or related conditions or symptoms, under study in the clinical study are permitted to participate in the clinical study. http://purl.obolibrary.org/obo/CTO_0000035 primary outcome measure information http://purl.obolibrary.org/obo/CTO_0000051 outcome specification A description of each primary outcome measure (or for observational studies, specific key measurement[s] or observation[s] used to describe patterns of diseases or traits or associations with exposures, risk factors or treatment). Each primary outcome measure information includes title, description and time frame. http://purl.obolibrary.org/obo/CTO_0000036 EU clinical trials register http://purl.obolibrary.org/obo/CTO_0000073 primary registry The EU clinical trials register is a primary clinical trial registry recognised by WHO and ICMJE that enables the registration of clinical trials. http://purl.obolibrary.org/obo/CTO_0000037 UMIN clinical trials registry http://purl.obolibrary.org/obo/CTO_0000073 primary registry The UMIN (University Hospital Medical Information Network Center) clinical trials registry is a Japanese primary clinical trial registry recognised by WHO and ICMJE that enables the registration of clinical trials. http://purl.obolibrary.org/obo/CTO_0000039 outcome measure result http://purl.obolibrary.org/obo/IAO_0000088 report Data generated from measurement of experimental variables in a study, or for observational studies, from descriptions of patterns of diseases or traits or associations with exposures, risk factors or treatment. http://purl.obolibrary.org/obo/CTO_0000040 human subjects protection review board status http://purl.obolibrary.org/obo/OPMI_0000326 status Indicate whether a clinical study has been reviewed and approved by at least one human subjects protection review board or such review is not required per applicable law (for example, 21 CFR Part 56, 45 CFR Part 46, or other applicable regulation). http://purl.obolibrary.org/obo/CTO_0000041 Korean clinical trials registry http://purl.obolibrary.org/obo/CTO_0000073 primary registry ClinicalTrials.gov is a registry of clinical trials. http://purl.obolibrary.org/obo/CTO_0000043 phase not applicable http://purl.obolibrary.org/obo/CTO_0000201 clinical trial phase Trials without phases (for example, studies of devices or behavioral interventions). http://purl.obolibrary.org/obo/CTO_0000044 retrospective study design http://purl.obolibrary.org/obo/OBI_0500000 study design Look back using observations collected predominantly prior to subject selection and enrollment http://purl.obolibrary.org/obo/CTO_0000045 International standard randomised controlled trial register identifier http://purl.obolibrary.org/obo/NCIT_C98714 Clinical Trial Registry Identifier A centrally registered identifier that is assigned for a specific clinical trial registered in the international standard randomised controlled trial register (ISRCT). The format for the registry number is “ISRCTN” followed by a 8-digit number, e.g., ISRCTN14966673. http://purl.obolibrary.org/obo/CTO_0000046 clinical trial phase 1/2 http://purl.obolibrary.org/obo/CTO_0000201 clinical trial phase Clinical trial phase that is a combination of phases 1 and 2. http://purl.obolibrary.org/obo/CTO_0000047 prospective study design http://purl.obolibrary.org/obo/OBI_0500000 study design Look forward using periodic observations collected predominantly following subject enrollment http://purl.obolibrary.org/obo/CTO_0000048 Thai clinical trials registry identifier http://purl.obolibrary.org/obo/NCIT_C98714 Clinical Trial Registry Identifier A centrally registered identifier that is assigned for a specific clinical trial registered in the Thai clinical trials registry (TCTR). The format for the registry number is “TCTR” followed by a 11-digit number, e.g., TCTR20200405001 http://purl.obolibrary.org/obo/CTO_0000049 Chinese clinical trial registry http://purl.obolibrary.org/obo/CTO_0000073 primary registry The Chinese clinical trial registry is a primary clinical trial registry recognised by WHO and ICMJE that enables the registration of clinical trials. http://purl.obolibrary.org/obo/CTO_0000050 Thai clinical trials registry http://purl.obolibrary.org/obo/CTO_0000073 primary registry The Thai clinical trials registry is a primary clinical trial registry recognised by WHO and ICMJE that enables the registration of clinical trials. http://purl.obolibrary.org/obo/CTO_0000051 outcome specification http://purl.obolibrary.org/obo/IAO_0000033 directive information entity A description of the outcome measure in an interventional study or for observational studies, specific key measurement[s] or observation[s] used to describe patterns of diseases or traits or associations with exposures, risk factors or treatment. http://purl.obolibrary.org/obo/CTO_0000052 Indian clinical trial registry identifier http://purl.obolibrary.org/obo/NCIT_C98714 Clinical Trial Registry Identifier A centrally registered identifier that is assigned for a specific clinical trial registered in the Indian clinical trial register. The format for the registry number is “CRTI/” followed by a 4-digit number, followed by a slash, followed a 2-digit number, followed by a slash, followed a 6-digit number, e.g., CTRI/2020/03/024402. http://purl.obolibrary.org/obo/CTO_0000053 Brazilian clinical trials registry http://purl.obolibrary.org/obo/CTO_0000073 primary registry The Brazilian clinical trials registry is a primary clinical trial registry recognised by WHO and ICMJE that enables the registration of clinical trials. http://purl.obolibrary.org/obo/CTO_0000054 jRCT clinical trial identifier http://purl.obolibrary.org/obo/CTO_0000209 Japan clinical trial identifier A centrally registered identifier that is assigned for a specific clinical trial registered in the Japan Registry of Clinical Trials (jRCT). The format for the registry number is “jRCTs” followed by a 9-digit number, e.g., JPRN-jRCTs031190227 http://purl.obolibrary.org/obo/CTO_0000055 Cuban public registry of clinical trials identifier http://purl.obolibrary.org/obo/NCIT_C98714 Clinical Trial Registry Identifier A centrally registered identifier that is assigned for a specific clinical trial registered in the Cuban public registry of clinical trials (RPCEC). The format for the registry number is “RPCEC” followed by a 8-digit number, e.g., RPCEC00000306. http://purl.obolibrary.org/obo/CTO_0000056 Lebanese clinical trials registry identifier http://purl.obolibrary.org/obo/NCIT_C98714 Clinical Trial Registry Identifier A centrally registered identifier that is assigned for a specific clinical trial registered in the Lebanese clinical trials registry (LBCTR). The format for the registry number is “LBCTR” followed by a 10-digit number, e.g., LBCTR2020043459. http://purl.obolibrary.org/obo/CTO_0000073 primary registry http://purl.obolibrary.org/obo/CTO_0000077 clinical trials registry organization A primary registry is clinical trial registry in the WHO registry network that meet specific criteria for content, quality and validity, accessibility, unique identification, technical capacity and administration. Primary registries also meet the requirements of the International Clinical Trials Registry Platform (ICMJE). http://purl.obolibrary.org/obo/CTO_0000074 Peruvian clinical trial registry http://purl.obolibrary.org/obo/CTO_0000073 primary registry The Peruvian clinical trial registry is a primary clinical trial registry recognised by WHO and ICMJE that enables the registration of clinical trials. http://purl.obolibrary.org/obo/CTO_0000075 Sri Lanka clinical trials registry http://purl.obolibrary.org/obo/CTO_0000073 primary registry The Sri Lanka clinical trials registry is a primary clinical trial registry recognised by WHO and ICMJE that enables the registration of clinical trials. http://purl.obolibrary.org/obo/CTO_0000076 US ClinicalTrial.gov registry http://purl.obolibrary.org/obo/CTO_0000073 primary registry ClinicalTrials.gov is a registry for clinical trials funded and maintained by NIH/NLM in US. http://purl.obolibrary.org/obo/CTO_0000077 clinical trials registry organization http://purl.obolibrary.org/obo/ERO_0001843 registry A clinical trials registry organization is an organization that enables the registration and documentation of clinical trials. http://purl.obolibrary.org/obo/CTO_0000109 drug clinical trial http://purl.obolibrary.org/obo/CTO_0000220 clinical trial A clinical trial investigate some molecular entity which either will be a new drug or is already an approved drug but looking for new indications or new populations that are not stated in the drug label. http://purl.obolibrary.org/obo/CTO_0000110 clinical trial sponsor role http://purl.obolibrary.org/obo/OBI_0000243 sponsor role a sponsor role that ties to a clinical trial. http://purl.obolibrary.org/obo/CTO_0000112 double blinded design http://purl.obolibrary.org/obo/CTO_0000005 masking design a study design in which neither the subjects nor the investigators are permitted to know which subject is receiving which treatment http://purl.obolibrary.org/obo/CTO_0000113 single blinded design http://purl.obolibrary.org/obo/CTO_0000005 masking design a study design in which only the investigators are permitted to know which subject is receiving which treatment http://purl.obolibrary.org/obo/CTO_0000114 open blinded design http://purl.obolibrary.org/obo/CTO_0000005 masking design a study design in which the subjects and the investigators are permitted to know which subject is receiving which treatment http://purl.obolibrary.org/obo/CTO_0000115 sequential design http://purl.obolibrary.org/obo/OBI_0000115 intervention design Groups of participants are assigned to receive interventions based on prior milestones being reached in the study, such as in some dose escalation and adaptive design studies http://purl.obolibrary.org/obo/CTO_0000116 single arm design http://purl.obolibrary.org/obo/OBI_0000115 intervention design study design with a single group (arm) http://purl.obolibrary.org/obo/BFO_0000148 zero-dimensional temporal region http://purl.obolibrary.org/obo/BFO_0000008 temporal region temporal instant. http://purl.obolibrary.org/obo/NCBITaxon_9606 Homo sapiens http://purl.obolibrary.org/obo/NCBITaxon_40674 Mammalia person http://purl.obolibrary.org/obo/CTO_0000208 European clinical trial registry identifier http://purl.obolibrary.org/obo/NCIT_C98714 Clinical Trial Registry Identifier EudraCT identifier http://purl.obolibrary.org/obo/CTO_0000210 JAPIC clinical trial identifier http://purl.obolibrary.org/obo/NCIT_C98714 Clinical Trial Registry Identifier JapicCTI http://purl.obolibrary.org/obo/CTO_0000108 investigational molecular entity http://purl.obolibrary.org/obo/CHEBI_23367 molecular entity http://purl.obolibrary.org/obo/CTO_0000107 investigational molecular entity administration http://purl.obolibrary.org/obo/OAE_0000002 medical intervention http://purl.obolibrary.org/obo/CTO_0000103 placebo medical intervention http://purl.obolibrary.org/obo/OAE_0000002 medical intervention http://purl.obolibrary.org/obo/BFO_0000003 occurrent http://purl.obolibrary.org/obo/BFO_0000001 entity http://purl.obolibrary.org/obo/BFO_0000008 temporal region http://purl.obolibrary.org/obo/BFO_0000003 occurrent http://purl.obolibrary.org/obo/BFO_0000011 spatiotemporal region http://purl.obolibrary.org/obo/BFO_0000003 occurrent http://purl.obolibrary.org/obo/BFO_0000141 immaterial entity http://purl.obolibrary.org/obo/BFO_0000004 independent continuant http://purl.obolibrary.org/obo/BFO_0000009 two-dimensional spatial region http://purl.obolibrary.org/obo/BFO_0000006 spatial region http://purl.obolibrary.org/obo/BFO_0000018 zero-dimensional spatial region http://purl.obolibrary.org/obo/BFO_0000006 spatial region http://purl.obolibrary.org/obo/BFO_0000026 one-dimensional spatial region http://purl.obolibrary.org/obo/BFO_0000006 spatial region http://purl.obolibrary.org/obo/BFO_0000028 three-dimensional spatial region http://purl.obolibrary.org/obo/BFO_0000006 spatial region http://purl.obolibrary.org/obo/BFO_0000038 one-dimensional temporal region http://purl.obolibrary.org/obo/BFO_0000008 temporal region http://purl.obolibrary.org/obo/BFO_0000182 history http://purl.obolibrary.org/obo/BFO_0000015 process http://purl.obolibrary.org/obo/OGMS_0000060 bodily process http://purl.obolibrary.org/obo/BFO_0000015 process http://purl.obolibrary.org/obo/BFO_0000034 function http://purl.obolibrary.org/obo/BFO_0000016 disposition http://purl.obolibrary.org/obo/BFO_0000016 disposition http://purl.obolibrary.org/obo/BFO_0000017 realizable entity http://purl.obolibrary.org/obo/OPMI_0000326 status http://purl.obolibrary.org/obo/BFO_0000017 realizable entity http://purl.obolibrary.org/obo/BFO_0000019 quality http://purl.obolibrary.org/obo/BFO_0000020 specifically dependent continuant http://purl.obolibrary.org/obo/BFO_0000024 fiat object part http://purl.obolibrary.org/obo/BFO_0000040 material_entity http://purl.obolibrary.org/obo/BFO_0000027 object aggregate http://purl.obolibrary.org/obo/BFO_0000040 material_entity http://purl.obolibrary.org/obo/BFO_0000030 object http://purl.obolibrary.org/obo/BFO_0000040 material_entity http://purl.obolibrary.org/obo/NCBITaxon_1 root http://purl.obolibrary.org/obo/BFO_0000040 material_entity http://purl.obolibrary.org/obo/BFO_0000142 one-dimensional continuant fiat boundary http://purl.obolibrary.org/obo/BFO_0000140 continuant fiat boundary http://purl.obolibrary.org/obo/BFO_0000146 two-dimensional continuant fiat boundary http://purl.obolibrary.org/obo/BFO_0000140 continuant fiat boundary http://purl.obolibrary.org/obo/BFO_0000147 zero-dimensional continuant fiat boundary http://purl.obolibrary.org/obo/BFO_0000140 continuant fiat boundary http://purl.obolibrary.org/obo/BFO_0000006 spatial region http://purl.obolibrary.org/obo/BFO_0000141 immaterial entity http://purl.obolibrary.org/obo/BFO_0000029 site http://purl.obolibrary.org/obo/BFO_0000141 immaterial entity http://purl.obolibrary.org/obo/CTO_0000104 outcome measurement datum http://purl.obolibrary.org/obo/IAO_0000027 data item http://purl.obolibrary.org/obo/OPMI_0000381 human subject http://purl.obolibrary.org/obo/NCBITaxon_9606 Homo sapiens http://purl.obolibrary.org/obo/CTO_0000099 clinical trial enrollment http://purl.obolibrary.org/obo/OBI_0600004 human subject enrollment http://purl.obolibrary.org/obo/CTO_0000119 investigational drug administration http://purl.obolibrary.org/obo/CTO_0000107 investigational molecular entity administration http://purl.obolibrary.org/obo/CTO_0000120 investigational supplement administration http://purl.obolibrary.org/obo/CTO_0000107 investigational molecular entity administration http://purl.obolibrary.org/obo/NCBITaxon_131567 cellular organisms http://purl.obolibrary.org/obo/NCBITaxon_1 root http://purl.obolibrary.org/obo/NCBITaxon_2759 Eukaryota http://purl.obolibrary.org/obo/NCBITaxon_131567 cellular organisms http://purl.obolibrary.org/obo/NCBITaxon_7742 Vertebrata http://purl.obolibrary.org/obo/NCBITaxon_2759 Eukaryota http://purl.obolibrary.org/obo/NCBITaxon_40674 Mammalia http://purl.obolibrary.org/obo/NCBITaxon_7742 Vertebrata http://purl.obolibrary.org/obo/CTO_0000026 age_between_18_and_64 http://purl.obolibrary.org/obo/NCIT_C25150 Age http://purl.obolibrary.org/obo/CTO_0000034 age_between_birth_and_17_years http://purl.obolibrary.org/obo/NCIT_C25150 Age http://purl.obolibrary.org/obo/CTO_0000038 age_older_than_64 http://purl.obolibrary.org/obo/NCIT_C25150 Age http://purl.obolibrary.org/obo/CTO_0000100 clinical trial participant http://purl.obolibrary.org/obo/OPMI_0000381 human subject http://purl.obolibrary.org/obo/CTO_0000101 healthy enrollee http://purl.obolibrary.org/obo/OPMI_0000381 human subject http://purl.obolibrary.org/obo/CTO_0000102 enrolled patient http://purl.obolibrary.org/obo/OPMI_0000381 human subject http://purl.obolibrary.org/obo/CTO_0000111 procedure clinical trIal http://purl.obolibrary.org/obo/ERO_0001402 feasibility study http://purl.obolibrary.org/obo/OPMI_0000389 contact of scientific queries http://purl.obolibrary.org/obo/OPMI_0000383 contact person http://purl.obolibrary.org/obo/OPMI_0000393 contact for public queries http://purl.obolibrary.org/obo/OPMI_0000383 contact person http://purl.obolibrary.org/obo/IAO_0000429 email address http://purl.obolibrary.org/obo/OPMI_0000397 contact person information http://purl.obolibrary.org/obo/CTO_0000209 Japan clinical trial identifier http://purl.obolibrary.org/obo/NCIT_C98714 Clinical Trial Registry Identifier http://purl.obolibrary.org/obo/CTO_0000117 primary outcome measurement http://purl.obolibrary.org/obo/CTO_0000016 clinical trial outcome measurement http://purl.obolibrary.org/obo/CTO_0000118 secondary outcome measurement http://purl.obolibrary.org/obo/CTO_0000016 clinical trial outcome measurement http://purl.obolibrary.org/obo/CTO_0000105 primary outcome measurement datum http://purl.obolibrary.org/obo/CTO_0000104 outcome measurement datum http://purl.obolibrary.org/obo/CTO_0000106 secondary outcome measurement datum http://purl.obolibrary.org/obo/CTO_0000104 outcome measurement datum http://purl.obolibrary.org/obo/BFO_0000001 entity http://purl.obolibrary.org/obo/RO_0002248 has active ingredient A relationship that holds between a substance and a chemical entity, if the chemical entity is part of the substance, and the chemical entity forms the biologically active component of the substance. http://purl.obolibrary.org/obo/BFO_0000055 realizes http://purl.obolibrary.org/obo/IAO_0000136 is about http://purl.obolibrary.org/obo/OBI_0000293 has_specified_input http://purl.obolibrary.org/obo/RO_0000057 has participant http://purl.obolibrary.org/obo/RO_0000059 concretizes http://purl.obolibrary.org/obo/CTO_0000126 has investigator http://purl.obolibrary.org/obo/CTO_0000127 has collaborator http://purl.obolibrary.org/obo/CTO_0000128 has contact http://purl.obolibrary.org/obo/CTO_0000129 has clinical trial site http://purl.obolibrary.org/obo/CTO_0000130 has primary sponsor http://purl.obolibrary.org/obo/CTO_0000131 has funding agency http://purl.obolibrary.org/obo/BFO_0000051 has part http://purl.obolibrary.org/obo/RO_0000087 has role http://purl.obolibrary.org/obo/RO_0002249 active ingredient in http://purl.obolibrary.org/obo/BFO_0000062 preceded_by http://purl.obolibrary.org/obo/OPMI_0000366 has process quality