A research study is a scientific investigation designed to generate health-related knowledge. This can include clinical trials involving human participants (or animals in the case of veterinary clinical trials). These studies may be related to new ways to screen, prevent, diagnose, and treat disease. Research studies may also analyze data collected from individuals in the past (retrospective studies) or future (prospective studies) to understand specific outcomes or trends in particular populations. A research study is a scientific investigation designed to generate health-related knowledge. This can include clinical trials involving human participants (or animals in the case of veterinary clinical trials). These studies may be related to new ways to screen, prevent, diagnose, and treat disease. Research studies may also analyze data collected from individuals in the past (retrospective studies) or future (prospective studies) to understand specific outcomes or trends in particular populations. If the element is present, it must have either a @value, an @id, or extensions Canonical identifier for this study resource, represented as a globally unique URI. Identifiers assigned to this research study by the sponsor or other systems. The business version for the study record. Name for this study (computer friendly). The human readable name of the research study. Additional names for the study. The set of steps expected to be performed as part of the execution of the study. A larger research study of which this particular study is a component or step. Display of the bibliographic citation of this ResearchStudy. Relationships that this ResearchStudy has with other FHIR or non-FHIR resources that already exist. The date (and optionally time) when the ResearchStudy Resource was last significantly changed. The date must change when the business version changes and it must change if the status code changes. In addition, it should change when the substantive content of the ResearchStudy Resource changes. The publication state of the resource (not of the study). The type of study based upon the intent of the study activities. A classification of the intent of the study. The stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation. Codes categorizing the type of study such as investigational vs. observational, type of blinding, type of randomization, safety vs. efficacy, etc. The medication(s), food(s), therapy(ies), device(s) or other concerns or interventions that the study is seeking to gain more information about. The condition that is the focus of the study. For example, In a study to examine risk factors for Lupus, might have as an inclusion criterion "healthy volunteer", but the target condition code would be a Lupus SNOMED code. Key terms to aid in searching for or filtering the study. A country, state or other area where the study is taking place rather than its precise geographic location or address. A brief text for explaining the study. A detailed and human-readable narrative of the study. E.g., study abstract. Identifies the start date and the expected (or actual, depending on status) end date for the study. A facility in which study activities are conducted. Comments made about the study by the performer, subject or other participants. Additional grouping mechanism or categorization of a research study. Example: FDA regulated device, FDA regulated drug, MPG Paragraph 23b (a German legal requirement), IRB-exempt, etc. Implementation Note: do not use the classifier element to support existing semantics that are already supported thru explicit elements in the resource. Sponsors, collaborators, and other parties. Status of study with time for that status. A description and/or code explaining the premature termination of the study. Target or actual group of participants enrolled in study. Describes an expected event or sequence of events for one of the subjects of a study. E.g. for a living subject: exposure to drug A, wash-out, exposure to drug B, wash-out, follow-up. E.g. for a stability study: {store sample from lot A at 25 degrees for 1 month}, {store sample from lot A at 40 degrees for 1 month}. A goal that the study is aiming to achieve in terms of a scientific question to be answered by the analysis of data collected during the study. Link to one or more sets of results generated by the study. Could also link to a research registry holding the results such as ClinicalTrials.gov. A research study is a scientific investigation designed to generate health-related knowledge. This can include clinical trials involving human participants (or animals in the case of veterinary clinical trials). These studies may be related to new ways to screen, prevent, diagnose, and treat disease. Research studies may also analyze data collected from individuals in the past (retrospective studies) or future (prospective studies) to understand specific outcomes or trends in particular populations. Kind of name. The name. Used to express the specific language of the title. A research study is a scientific investigation designed to generate health-related knowledge. This can include clinical trials involving human participants (or animals in the case of veterinary clinical trials). These studies may be related to new ways to screen, prevent, diagnose, and treat disease. Research studies may also analyze data collected from individuals in the past (retrospective studies) or future (prospective studies) to understand specific outcomes or trends in particular populations. The type of relationship to the related artifact. The artifact that is related to this ResearchStudy Resource. A research study is a scientific investigation designed to generate health-related knowledge. This can include clinical trials involving human participants (or animals in the case of veterinary clinical trials). These studies may be related to new ways to screen, prevent, diagnose, and treat disease. Research studies may also analyze data collected from individuals in the past (retrospective studies) or future (prospective studies) to understand specific outcomes or trends in particular populations. Name of associated party. Type of association. Identifies the start date and the end date of the associated party in the role. A categorization other than role for the associated party. Individual or organization associated with study (use practitionerRole to specify their organisation). A research study is a scientific investigation designed to generate health-related knowledge. This can include clinical trials involving human participants (or animals in the case of veterinary clinical trials). These studies may be related to new ways to screen, prevent, diagnose, and treat disease. Research studies may also analyze data collected from individuals in the past (retrospective studies) or future (prospective studies) to understand specific outcomes or trends in particular populations. Label for status or state (e.g. recruitment status). An indication of whether or not the date is a known date when the state changed or will change. A value of true indicates a known date. A value of false indicates an estimated date. Date range. A research study is a scientific investigation designed to generate health-related knowledge. This can include clinical trials involving human participants (or animals in the case of veterinary clinical trials). These studies may be related to new ways to screen, prevent, diagnose, and treat disease. Research studies may also analyze data collected from individuals in the past (retrospective studies) or future (prospective studies) to understand specific outcomes or trends in particular populations. Estimated total number of participants to be enrolled. Actual total number of participants enrolled in study. Inclusion and exclusion criteria. The referenced Group Resource should have a membership element value of either 'definitional' or 'conceptual'. Group of participants who were enrolled in study. The referenced Group Resource should have a membership element value of 'enumerated'. Free text description of the recruitment of the study. A research study is a scientific investigation designed to generate health-related knowledge. This can include clinical trials involving human participants (or animals in the case of veterinary clinical trials). These studies may be related to new ways to screen, prevent, diagnose, and treat disease. Research studies may also analyze data collected from individuals in the past (retrospective studies) or future (prospective studies) to understand specific outcomes or trends in particular populations. Estimated total number of participants to be enrolled in the comparison group. Actual total number of participants enrolled in the comparison group. Inclusion and exclusion criteria for the comparison group as a subset of the eligibility for the overall study. The referenced Group Resource should have a membership element value of either 'definitional' or 'conceptual'. Group of participants who were enrolled in the comparison group as a subset of those enrolled in the overall study. The referenced Group Resource should have a membership element value of 'enumerated'. Description of the comparison Group. A research study is a scientific investigation designed to generate health-related knowledge. This can include clinical trials involving human participants (or animals in the case of veterinary clinical trials). These studies may be related to new ways to screen, prevent, diagnose, and treat disease. Research studies may also analyze data collected from individuals in the past (retrospective studies) or future (prospective studies) to understand specific outcomes or trends in particular populations. Unique, human-readable label for this objective of the study. The kind of study objective. Free text description of the objective of the study. This is what the study is trying to achieve rather than how it is going to achieve it (see ResearchStudy.description). An "outcome measure", "endpoint", "effect measure" or "measure of effect" is a specific measurement or observation used to quantify the effect of experimental variables on the participants in a study, or for observational studies, to describe patterns of diseases or traits or associations with exposures, risk factors or treatment. A research study is a scientific investigation designed to generate health-related knowledge. This can include clinical trials involving human participants (or animals in the case of veterinary clinical trials). These studies may be related to new ways to screen, prevent, diagnose, and treat disease. Research studies may also analyze data collected from individuals in the past (retrospective studies) or future (prospective studies) to understand specific outcomes or trends in particular populations. Label for the outcome measure. The kind of outcome measure. Description of the outcome measure. Definition of the outcome measure. Population for this estimand. Comparison group of interest. Comparison group for comparison. Statistical measure for treatment effect estimate. The planned statistical model for analysis of a single endpoint. Handling of intercurrent event. A research study is a scientific investigation designed to generate health-related knowledge. This can include clinical trials involving human participants (or animals in the case of veterinary clinical trials). These studies may be related to new ways to screen, prevent, diagnose, and treat disease. Research studies may also analyze data collected from individuals in the past (retrospective studies) or future (prospective studies) to understand specific outcomes or trends in particular populations. The event. The group that is affected by this event handling. How the data is handled. Text summary of event handling.