A process where a researcher or organization plans and then executes a series of steps intended to increase the field scientific study of healthcare-related knowledge. This nature that sometimes includes studies of safety, efficacy, comparative effectiveness processes involved in health and other information about medications, devices, therapies disease. For example, clinical trials are research studies that involve people. These studies may be related to new ways to screen, prevent, diagnose, and other interventional treat disease. They may also study certain outcomes and investigative techniques. A ResearchStudy involves the gathering certain groups of information about human people by looking at data collected in the past or animal subjects. future.

Need to make sure we encompass public health studies.

Canonical identifier for this study resource, represented as a globally unique URI.

Identifiers assigned to this research study by the sponsor or other systems.

Allows identification of the research study as it is known by various participating systems and in a way that remains consistent across servers.

The business version for the study record.

Name for this study (computer friendly).

A short, descriptive user-friendly label for The human readable name of the research study.

Additional names for the study.

Kind of name.

The name.

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.

Allows breaking a study into components (e.g. by study site) each with their own PI, status, enrollment, etc.

Citations, references and other related documents.

The date (and optionally time) when the ResearchStudy Resource was published. 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 current publication state of the study. resource (not of the study).

The type of study based upon the intent of the study's 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.

Identification of product under study. This may be any combination of code and/or name.

The condition that is Indicates whether the focus of the study. For example, In is a study to examine risk factors for Lupus, might have as an inclusion criterion "healthy volunteer", but the target condition code would be medication, a Lupus SNOMED code. device, a procedure, a specific factor or some other intervention or characteristic.

Contact details A factor corresponds to assist a user in learning more about or engaging an independent variable manipulated by the experimentalist with the study. intention to affect biological systems in a way that can be measured by an assay.

Citations, references and other related documents. 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.

Indicates a A country, state or other region area where the study is taking place. place rather than its precise geographic location or address.

A brief text for explaining the study.

A full description detailed and human-readable narrative of how the study. E.g., study is being conducted. abstract.

Reference to a Group that defines Identifies the criteria for start date and quantity of subjects participating in the expected (or actual, depending on status) end date for the study. E.g. " 200 female Europeans between

A facility in which study activities are conducted.

Comments made about the study by the performer, subject or other participants.

The Group referenced should 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 generally enumerate specific subjects. Subjects will be linked to use the study using classifier element to support existing semantics that are already supported thru explicit elements in the ResearchSubject resource.

Identifies the start date Sponsors, collaborators, and the expected (or actual, depending on status) end date other parties.

While there are explicit attributes for a Sponsor and a PrincipalInvestigator many trial record a range of other organizations and individuals in key roles.

For a Sponsor or a PrincipalInvestigator use the study. dedicated attributes provided.

Name of associated party.

Type of association.

An organization that initiates Identifies the investigation start date and is legally responsible for the study. end date of the associated party in the role.

The cardinality is 0..* due to the fact that an associated party may be intermittently active in a given role over multiple time periods.

A categorization other than role for the associated party.

A researcher in a Individual or organization associated with study who oversees multiple aspects of the study, such as concept development, protocol writing, protocol submission for IRB approval, participant recruitment, informed consent, data collection, analysis, interpretation and presentation. (use practitionerRole to specify their organisation).

Suggestions of a better attribute name are appreciated

A facility in which Status of study activities are conducted. with time for that status.

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 description and/or code explaining the premature termination of the study.

Comments made about the study by the performer, subject Target or other participants. actual group of participants enrolled in study.

Estimated total number of participants to be enrolled.

Actual total number of participants enrolled in study.

Inclusion and exclusion criteria.

Group of participants who were enrolled in study.

Describes an expected sequence of events for one of the participants of a study. E.g. Exposure to drug A, wash-out, exposure to drug B, wash-out, follow-up.

In many clinical trials this is refered to as the ARM of the study, but such a term is not used in other sorts of trials even when there is a comparison between two or more groups.

Allows the comparisonGroup for the study and the comparisonGroup for the subject to be linked easily.

Unique, human-readable label for this arm comparisonGroup of the study.

Categorization of study arm, comparisonGroup, e.g. experimental, active comparator, placebo comparater.

A succinct description of the path through the study that would be followed by a subject adhering to this arm. comparisonGroup.

Interventions or exposures in this comparisonGroup or cohort.

this is necessary for ClinicalTrials.gov use which relates 1 to many interventions to comparisonGroups (aka arms)

Group of participants who were enrolled in study comparisonGroup.

This is necessary to relate comparisonGroups to actual groups

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.

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 or planned variable to measure during the study.

Label for the outcome.

The parameter or characteristic being assessed as one of the values by which the study is assessed.

Description of the outcome.

Structured outcome definition.

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 general storage or archive location for the study. This may contain an assortment of content which is not specified in advance.

Describes the nature of the location being specified.

The location address.