The Study Cohort Ontology (SCO) is developed to model overall structure and patterns of cohort variables and control/intervention groups defined within the structured population descriptions (commonly referred to as Table1's or Cohort Summary Tables)of observational case studies and clinical trials. We maintain only domain agnostic and commonly occuring subject variables and interventions in SCO, and we have a suite of ontologies (Diseases, Medications, LabResults etc) to encode Diabetes related terminology. We have adopted a bottom-up approach to modeling and we have revised the structure of SCO upon investigation of a few research studies (11 to be precise) from the Pharmacological Interventions (Chapter 8) and Cardiovascular Complications (Chapter 9) of the American Diabetes Association (ADA)’s Standards of Medical Care 2018 CPG. We enable deep drive visualizations driven off queries to knowledge graphs modeled on SCO, to help assist physician visualize the similarity of a patient to a study group, at a quick glance. We welcome contributions and suggestions to extend SCO to represent cohort descriptions of publications targeted to other diseases, and we plan to release set of tools to make this process seamless. Deborah L. McGuinness James P. McCusker Oshani Seneviratne Shruthi Chari The Study Cohort Ontology encodes the vocabulary to represent population desriptions in research studies, and provides the ability to model the aggregative descriptive statistical measures defined on the variables of subjects who are participants in the study population. We make it possible to represent a study component considered for determining the patient alignment to a research study, and we assist physicians in evaluating the fit of their patient population to the study population. In SCO, we are building a world-view inspired by the upper level Ontology SemanticScience Integrated Ontology (SIO) to model the descriptive statistics of characteristics on a set of patients (patient group) administered a medical intervention, and studied for an outcome in a research study. Since we capture the various definitions of patient groups (ie. by interventional measures or by control mechanisms), we provide the basic framework for filtering searches and to define cohort similarity at different granularities. ( cohort level and the study group levels ). For researchers who wish to contribute to the expansion of our ontology, we advise that they refer to our ontology documentation to familiarize themselves with the structure and term annotations ( such as definitions and labels). Semantic Modeling of Cohort Descriptions in Research Studies Study Cohort Ontology Miller-Keane Encyclopedia and Dictionary of Medicine, Nursing, and Allied Health, Seventh Edition the science dealing with populations, including matters of health, disease, births, and mortality https://en.wikipedia.org/wiki/Therapy medical therapy the attempted remediation of a health problem, usually following a diagnosis Normal or Underweight Underweight or Normal anatomical entity anatomical structure connected anatomical structure material anatomical entity material anatomical entity multicellular anatomical structure biological entity cell cell http://ontology.buffalo.edu/medo/Disease_and_Diagnosis.pdf disease or condition A disease is a disposition (i) to undergo pathological processes that (ii) exists in an organism because of one or more disorders in that organism Accumulation of substantial excess body fat. MSH:D009765 SNOMEDCT_US:414915002 SNOMEDCT_US:414916001 UMLS:C0028754 Having too much body fat Obesity human_phenotype HP:0001513 Obesity Obesity located preferentially in the trunk of the body as opposed to the extremities. HP:0008885 MSH:D056128 SNOMEDCT_US:248311001 UMLS:C0311277 Centripetal obesity Truncal obesity human_phenotype HP:0001956 Truncal obesity Abnormally increased body weight. peter 2008-02-27T03:21:00Z HP:0045083 MSH:D015430 SNOMEDCT_US:161831008 SNOMEDCT_US:262286000 SNOMEDCT_US:8943002 UMLS:C0043094 Increased body weight human_phenotype Weight gain HP:0004324 Increased body weight Abnormally low body weight. peter 2008-02-27T03:22:00Z HP:0001823 HP:0001826 MSH:D013851 MSH:D015431 SNOMEDCT_US:161832001 SNOMEDCT_US:248342006 SNOMEDCT_US:262285001 SNOMEDCT_US:89362005 UMLS:C0041667 UMLS:C1262477 UMLS:C1844806 Decreased body weight Decreased weight Low body weight Low weight Underweight Weight less than 3rd percentile human_phenotype HP:0004325 Decreased body weight Truncal obesity with onset during childhood, defined as between 2 and 10 years of age. HP:0008874 UMLS:C1859846 Truncal obesity apparent in childhood human_phenotype HP:0008915 Childhood-onset truncal obesity Excessive fat around the stomach and abdomen. peter 2014-03-23T05:00:05Z MSH:D056128 SNOMEDCT_US:248311001 UMLS:C0311277 Abdominal obesity Central obesity human_phenotype HP:0012743 Abdominal obesity Obesity with a body mass index of 30 to 34.9 kg per square meter. HPO:probinson 2017-05-14T20:06:40Z Class 1 obesity Obesity grade 1 Class I obesity Obesity with a body mass index of 35 to 39.9 kg per square meter. HPO:probinson 2017-05-14T20:08:43Z Class 2 obesity Obesity grade 2 Class II obesity Obesity with a body mass index of 40 kg per square meter or higher. HPO:probinson 2017-05-14T20:09:17Z Class 3 obesity Obesity grade 3 Class III obesity Increased body weight with a body mass index of 25-29.9 kg per square meter. HPO:probinson 2017-05-14T20:12:36Z Overweight Abnormally decreased weight-to-height squared ratio, calculated by dividing the individual's weight in kilograms by the square of the individual's height in meters and used as an indicator of underweight compared to averages. Decreased BMI Decreased body mass index Review of clinical information to determine veracity, thoroughness, and dependability. C142488 Activity Data Monitoring CDISC-GLOSS Process by which clinical data are examined for completeness, consistency, and accuracy. Data Monitoring data monitoring data monitoring A clinical trial in which computerized systems are used to plan, collect, access, exchange, and archive data. C142526 Research Activity Electronic Clinical Trial CDISC-GLOSS Clinical trial in which primarily electronic processes are used to plan, collect (acquire), access, exchange, and archive data required for conduct, management, analysis, and reporting of the trial. NOTE: FDA has recently drawn a distinction between studies and trials. Both words refer to systematic efforts to obtain evidence relevant to regulatory authorities, but, depending on regulatory context and particularly in the case of postmarketing commitments, a study might not be the appropriate word for a clinical trial (prospective, controlled, randomized), but should be reserved instead for surveillance, structured gathering of information, epidemiological studies, or even animal studies [DRAFT Guidance for industry Postmarketing studies and Clinical Trials-implementation of section 505(o) of the Federal Food, Drug, and Cosmetic act]. Synonyms: eClinical study, eClinical investigation. Electronic Clinical Trial eClinical Trial eclinical trial electronic clinical trial A clinical trial with the objective of demonstrating clinical insignificance between the responses to two or more treatments. C142539 Research Activity Equivalence Trial CDISC-GLOSS A trial with the primary objective of showing that the response to two or more treatments differs by an amount that is clinically unimportant. NOTE: This is usually demonstrated by showing that the true treatment difference is likely to lie between a lower and an upper equivalence margin of clinically acceptable differences. Equivalence Trial equivalence trial equivalence trial A type of clinical trial that involves low dosage and short duration of drug exposure for a limited number of study participants with the intent of gathering preliminary data on the mechanism of action, pharmacodynamics, pharmacokinetics, or bioavailability of promising therapeutic candidate agents in human subjects. C142547 Research Activity Exploratory Investigational New Drug Study CDISC-GLOSS A clinical study that is conducted early in Phase 1; involves very limited human exposure and has no therapeutic or diagnostic intent (e.g., screening studies, microdose studies) [FDA Guidance for industry, investigators, and Reviewers: exploratory IND studies, January 2006] See also Phase 0. Exploratory IND Study Exploratory Investigational New Drug Study exploratory IND study exploratory investigational new drug study A clinical trial that is non-interventional by design but includes diagnostic or monitoring procedures that carry minimal risk or impact on patients. C142601 Research Activity Low-interventional Clinical Trial CDISC-GLOSS A clinical trial which fulfills all of the following conditions: (a) the investigational medicinal products, excluding placebos, are authorized; (b) according to the protocol of the clinical trial, (i) the investigational medicinal products are used in accordance with the terms of the marketing authorization; or (ii) the use of the investigational medicinal products is evidence-based and supported by published scientific evidence on the safety and efficacy of those investigational medicinal products in any of the Member States concerned; and (c) the additional diagnostic or monitoring procedures do not pose more than minimal additional risk or burden to the safety of the subjects compared to normal clinical practice in any Member State concerned. [REGULATION (EU) No 536/2014 Article 2.2.(3)] Low-interventional Clinical Trial low-interventional clinical trial low-interventional clinical trial A type of clinical trial in which the therapeutic benefits of a marketed product are either clarified or preferentially compared to another marketed product. C142603 Research Activity Marketing Support Trials CDISC-GLOSS Clinical studies that are designed to clarify therapeutic benefits of a marketed product or to show potential decision-makers the rationale for preferring one therapy over another. Marketing Support Trials marketing support trials marketing support trials A type of clinical trial in which 10,000 or more subjects are enrolled. C142609 Research Activity Mega-Trial CDISC-GLOSS Massive trials that test the advantages of therapeutic interventions by enrolling 10,000 or more subjects. Mega-Trial large sample trial mega-trials mega-trial A study designed to test the effectiveness of an intervention in a broad routine clinical practice. C142641 Research Activity Pragmatic Trial CDISC-GLOSS Term used to describe a clinical study designed to examine the benefits of a product under real world conditions. Pragmatic Trial pragmatic trial pragmatic trial A trial with the primary objective of showing that the response to the investigational product is superior to a comparative agent (active or placebo control). (ICH) C142722 Research Activity Superiority Trial CDISC-GLOSS A trial with the primary objective of showing that the response to the investigational product is superior to a comparative agent (active or placebo control). [ICH E9] Superiority Trial superiority trial superiority trial Research conducted with human subjects or on material of human origin in which an investigator directly interacts with human subjects; includes development of new technologies, study of mechanisms of human diseases, therapy, clinical trials, epidemiologic, behavior, and health services research. C15206 Research Activity Clinical Study C0008972 CDISC CDISC-GLOSS FDA A clinical study involves research using human volunteers (also called participants) that is intended to add to medical knowledge. There are two main types of clinical studies: clinical trials (also called interventional studies) and observational studies. [ClinicalTrials.gov] See also clinical trial. A clinical study involves research using human volunteers (also called participants) that is intended to add to medical knowledge. There are two main types of clinical studies: clinical trials (also called interventional studies) and observational studies. [ClinicalTrials.gov] See also clinical trial. (CDISC Glossary) Clinical_Study CLINICAL STUDY Clinical Research Clinical Studies Clinical Study Study clinical study clinical study An uncontrolled observational study containing a detailed report of the diagnosis, treatment, and follow-up of an individual patient. Case reports also contain some demographic information about the patient (for example, age, gender, ethnic origin). C15362 Research Activity Case Study C0085973 CDISC A detailed report of the diagnosis, treatment, and follow-up of an individual patient. Case reports also contain some demographic information about the patient (for example, age, gender, ethnic origin). A study in which the subject with the condition under study (the case) is compared against a theoretical/historical model of distribution that serves as a control. Case_Study CASE ONLY Case Report Case Study case report case study Systematic investigation into a subject in order to discover facts, establish or revise a theory, or develop a plan of action based on the facts discovered. C15429 Research Activity Research Activity C0242481 A scientific study of nature that sometimes includes processes involved in health and disease. For example, clinical trials are research studies that involve people. These studies may be related to new ways to screen, prevent, diagnose, and treat disease. They may also study certain outcomes and certain groups of people by looking at data collected in the past or future. Research_Activity Research Research Activity research study research activity 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. C15602 Research Activity Phase III Trial C0282461 CDISC CDISC-GLOSS A study to compare the results of people taking a new treatment with the results of people taking the standard treatment (for example, which group has better survival rates or fewer side effects). In most cases, studies move into phase III only after a treatment seems to work in phases I and II. Phase III trials may include hundreds of people. Phase 3. Studies are expanded controlled and uncontrolled trials. They are performed after preliminary evidence suggesting effectiveness of the drug has been obtained, and are intended to gather the additional information about effectiveness and safety that is needed to confirm efficacy and evaluate the overall benefit-risk relationship of the drug and to provide an adequate basis for physician labeling. NOTE: Phase 3 studies usually include from several hundred to several thousand subjects. [After FDA CDER Handbook, ICH E8] (CDISC glossary) Studies are expanded controlled and uncontrolled trials. They are performed after preliminary evidence suggesting effectiveness of the drug has been obtained and are intended to gather the additional information about effectiveness and safety that is needed to confirm efficacy and evaluate the overall benefit-risk relationship of the drug and to provide an adequate basis for physician labeling. NOTE: Phase 3 studies usually include from several hundred to several thousand subjects. [after FDA CDER handbook, ICH E8] Phase_III_Trial 3 Clinical Trials, Phase III PHASE III TRIAL Phase 3 Study Phase III Clinical Trial Phase III Protocol Phase III Study Phase III Trial Phase III Trials Trial Phase 3 phase 3 phase III trial phase III trial A clinical research protocol designed to study the safety, dosage levels and response to new treatment. Phase I/II trials combine a Phase I and a Phase II trial of the same treatment into a single protocol. C15693 Research Activity Phase I/II Trial C1519043 CDISC A class of clinical study that combines elements characteristic of traditional Phase I and Phase II trials. See also Phase I, Phase II. A trial to study the safety, dosage levels, and response to a new treatment. Phase_I_II_Trial 1-2 PHASE I/II TRIAL Phase I/II Trial Phase I/II trial Trial Phase 1-2 Trial Phase 1/2 phase I/II trial Select candidate vaccines or concepts suitable for Phase I and Phase II trials and conduct these trials. C15835 Research Activity Phase I and II Vaccine Trials C1519044 Phase_I_and_II_Vaccine_Trials Phase I and II Vaccine Trials phase I and II Vaccine trial C15864 Research Activity Vaccine Clinical Trial C1519888 Vaccine_Clinical_Trial Vaccine Clinical Trial vaccine clinical trial Select suitable vaccine candidates and support efficacy trials when appropriate criteria are met. C15873 Research Activity Phase III Large Scale Vaccine Trial C1519902 Vaccine_Trial-Phase_III_Large_Scale Phase III Large Scale Vaccine Trial Vaccine Trial-Phase III Large Scale phase III large scale vaccine trial C16104 Research Activity Multi-Institutional Clinical Trial C0206012 CDISC-GLOSS A clinical trial that is carried out at more than one medical institution. Clinical trial conducted according to a single protocol but at more than one site and, therefore, carried out by more than one investigator. [ICH E9 Glossary] See investigator/ institution. Multi-Institutional_Clinical_Trial Multi-Institutional Clinical Trial multicenter study multicenter trial multi-institutional clinical trial A clinical trial that is not therapeutic, preventive or diagnostic. C16123 Research Activity Clinical Trial, Other C1516648 Clinical_Trials_Other Clinical Trial, Other Clinical Trials, Other Other Clinical Trial clinical trial, other Any specific activity undertaken during the course of a clinical study or research protocol. C16203 Activity Clinical or Research Activity C1516654 Clinical_or_Research_Activity Clinical or Research Activity clinical or research activity Denotes a person having origins in any indigenous people of Alaska and their descendants and who maintains tribal affiliation, or community or cultural attachment. The concept refers to population subgroups such as Eskimos, Aleuts, Inupiat, Yupik, Alutiiq, Egegik,and Pribilovian, Alaskan Athabascan, Tlingit, and Haida. The concept refers also to individuals who classify themselves as such. C18237 Population Group Alaska Native C0682125 The native people of Alaska. Alaska_Native ALASKA NATIVE Alaska Indian Alaska Indians Alaska Native Alaska Natives Alaskan Native Alaska Native A clinical trial that uses materials from some other clinical trial. C18707 Governmental or Regulatory Activity Adjunct Clinical Trial C1516638 Clinical_Trials_Adjunct Adjunct Clinical Trial Clinical Trial, Adjunct Clinical Trials, Adjunct adjunct clinical trial A fraction or ratio with 100 understood as the denominator. C25613 Conceptual Entity Percentage C0439165 CDISC NCPDP One hundred times the quotient of one quantity divided by another, with the same units of measurement. Percentage % Percentage percentage AMERICAN INDIAN OR ALASKA NATIVE American Indian or Alaska Native First Nations Native American Native Americans american indian or alaska native An active process; excludes processes and mechanisms which fulfill biological functions. C43431 Activity Activity C0441655 BRIDG Any action that can, in the context of a study or a post-marketing investigation, be defined, planned, scheduled or performed. EXAMPLE(S): surgical procedure, laboratory test, administration of a drug. Activity Activity General activity activity Denotes a person having origins in one of the indigenous peoples of North America, who lived on the continent prior to the European colonization. The term includes individuals belonging to a large number of tribes, states, and ethnic groups, many of them still enduring as communities. C43877 Population Group American Indian C0002460 The native people of North America. American_Indian AMERICAN INDIAN American Indian American Indian Quotient of quantities of the same kind for different components within the same system. C44256 Quantitative Concept Ratio C0456603 CDISC UCUM The quotient of one quantity divided by another, with the same units of measurement. Ratio RATIO Ratio ratio {RATIO} {Ratio} ratio The act of observing something (and sometimes keeping a record of it). C61256 Activity Monitoring CL415337 In medicine, to regularly watch and check a person or condition to see if there is any change. Also refers to a device that records and/or displays patient data, such as for an electrocardiogram (EKG). Monitoring Monitoring monitor monitoring A detailed examination, analysis, or critical inspection of a subject designed to discover facts about it. C63536 Research Activity Study C0947630 Study Study study C70820 Research Activity Clinical Study by Phase C2347801 Clinical_Study_by_Phase Clinical Study by Phase clinical study by phase C70824 Research Activity Clinical Study by Organizational Parameters C2347800 Clinical_Study_by_Organizational_Parameters Clinical Study by Organizational Parameters clinical study by organizational parameters quality (PATO) quality qualitative deviation(from_normal) weight abnormal increased weight physical quality force physical object quality A process quality inhering in a bearer by virtue of the bearer's magnitude of the temporal extent between the starting and ending point. PATO:0000081 period quality time PATO:0001309 duration pathological increased force increased quality increased object quality is a population whose individual members realize (may be expressed as) a combination of inclusion rule values specifications or resulting from a sampling process (e.g. recruitment followed by randomization to group) on which a number of measurements will be carried out, which may be used as input to statistical tests and statistical inference. Alejandra Gonzalez-Beltran Orlaith Burke Philippe Rocca-Serra STATO statistical sample study group population anatomical structure anatomical entity A unit which is a standard measure of the distance between two points. george gkoutos unit.ontology UO:0000001 length unit A unit which is a standard measure of the amount of matter/energy of a physical object. george gkoutos unit.ontology UO:0000002 mass unit A mass unit which is equal to the mass of the International Prototype Kilogram kept by the BIPM at Svres, France. george gkoutos kg unit.ontology UO:0000009 kilogram A length unit which is equal to one hundredth of a meter or 10^[-2] m. george gkoutos centimetre cm unit.ontology UO:0000015 centimeter A unit which is one of a particular measure to which all measures of that type can be related. george gkoutos unit.ontology UO:0000045 base unit mean the central value of a discrete set of numbers: specifically, the sum of the values divided by the number of values https://www.tititudorancea.com/z/patient_en.htm patient a person who receives medical attention, care, or treatment, or who is registered with medical professional or institution with the purpose to receive medical care when necessary standard deviation a measure that is used to quantify the amount of variation or dispersion of a set of data values https://en.wikipedia.org/wiki/Research_participant study subject A research participant, also called a human subject or an experiment, trial, or study participant or subject, is a person who participates in human subject research by being the target of observation by researchers unit of measurement Statistical measure describing the distribution of single variable http://purl.bioontology.org/ontology/SNOMEDCT/386053000 Statistical measure characterizing the distribution of single variable Capturing the interventions variables in research studies The intervention type used in a research study (corresponding to I in the PICO(T) model ) study intervention http://purl.bioontology.org/ontology/SNOMEDCT/386053000 Study intervention statistical measure a standard unit used to express the size, amount, or degree of something Clinical Trials Protocol Template - NIH Office of Science Policy https://osp.od.nih.gov/wp-content/uploads/2014/01/Protocol_Template_05Feb2016_508.pdf active participants following clinical trial protocol All typical components that constitute the description of study populations, captured in the first table of a research study, and hence called Table 1s cohort description Table 1 Clinical Trials Protocol Template - NIH Office of Science Policy https://osp.od.nih.gov/wp-content/uploads/2014/01/Protocol_Template_05Feb2016_508.pdf discontinued participants no longer, following clinical trial protocol electronic health record a digital version of a patient’s paper chart https://research-compliance.umich.edu/sites/default/files/resource-download/enrollmentdefinition_additionalhelp.pdf enrollment status patients are consented and screened, with eligibility verified https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3159210/ intention to treat population every subject who is randomized according to randomized treatment assignment, ignoring noncompliance, protocol deviations, withdrawal, and anything that happens after randomization laboratory test result https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4296634/ population size number of patients to which the study results could be reasonably generalized R. J. Little et al., "The prevention and treatment of missing data in clinical trials," New England J. Medicine, vol. 367, no. 14, pp. 1355{1360, 2012 subject characteristic Property that summarizes important attributes of the participants enrolled in a study A scientific investigation that involves testing a hypothesi A scientific study of nature that sometimes includes processes involved in health and disease A prospective study designed to evaluate whether one or more interventions are associated with an outcome A prospective study designed to evaluate whether one or more interventions are associated with an outcome A cohort is the group of subjects enrolled in a study" "Top-level group of subjects participating in a study" An arm type that can receive an intervention that is considered effective (the standard), a placebo, or no intervention https://aidsinfo.nih.gov/understanding-hiv-aids/glossary/3392/control-arm An arm type in which a group of participants receives the intervention/treatment that is the focus of the clinical trial https://clinicaltrials.gov/ct2/about-studies/glossary A quantitative, formal, epidemiological study design used to systematically assess previous research studies to derive conclusions about that body of research https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3049418/ set of patients recruited for research studies, who are randomly assigned to different study groups, intending to ensure that all potential confounding factors are divided equally among the groups that will later be compared (structural equivalence) https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3196997/ set of patients recruited for research studies, who are a part of the experimental treatment population, additionally patients receiving the experimental intervention is analyzed with the experimental group https://www.dummies.com/education/science/biology/how-to-define-analytical-populations-for-a-clinical-study/ https://www.ncbi.nlm.nih.gov/books/NBK209903/ An arm in a clinical trial is a group of subjects receiving the same therapeutic intervention (or none) A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol. https://clinicaltrials.gov/ct2/about-studies/glossary Non-Hispanic Other Race research study study Black Hispanic Hispanic Populations Hispanic or Latino Hispanics or Latinos Latino Population Spanish Origins Hawaiiaan Pacific Islander Hawaiian or Pacific Islander CDISC-GLOSS Research Activity 1) A research investigation involving human subjects that is designed to answer specific questions about the safety and efficacy of a biomedical intervention (drug, treatment, device) or new ways of using a known drug, treatment, or device). 2) A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.(1. modified from ICH E6 Glossary, Directive 2001/20/EC. 2. NIH revised definition 2015) (CDISC Glossary) Clinical Trial clinical trial A type of research study that tests how well new medical approaches work in people. These studies test new methods of screening, prevention, diagnosis, or treatment of a disease. Clinical Trials C71104 clinical trial CDISC A research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes. C0008976 A research investigation involving human subjects that is designed to answer specific questions about the safety and efficacy of a biomedical intervention (drug, treatment, device) or new ways of using a known drug, treatment, or device). NOTE: NIH Office of Science Policy further specifies that a clinical trial is a type of research study that prospectively assigns subjects to interventions, and the EU clinical trial regulations set forth 3 specific conditions, any one of which qualifies a study as a clinical trial. These conditions include applying diagnostic or monitoring procedures not used in normal clinical practice to subjects. [after ICH E6 [R2], EU CTR 2014] See also clinical study, clinical investigation. Clinical Trials, Unspecified Trial Clinical_Trial_Generic Clinical Trial STATO a cohort is a study group population where the members are human beings which meet inclusion criteria and undergo a longitudinal design Orlaith Burke Philippe Rocca-Serra cohort possibly submit to 'Population and Community Ontology' Alejandra Gonzalez-Beltran BMI http://semanticscience.org/resource/SIO_001068.rdf control arm intervention arm http://semanticscience.org/resource/SIO_001069.rdf meta-analysis randomized population safety population study arm