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, URLs and other related documents. When using relatedArtifact to share URLs, the relatedArtifact.type will often be set to one of "documentation" or "supported-with" and the URL value will often be in relatedArtifact.document.url but another possible location is relatedArtifact.resource when it is a canonical URL.

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 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.

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.

Contact details Key terms to assist a user aid in learning more about searching for or engaging with filtering the study.

Citations, references and A country, state or other related documents. area where the study is taking place rather than its precise geographic location or address.

Key terms to aid in searching A brief text for or filtering explaining the study.

A detailed and human-readable narrative of the study. E.g., study abstract.

Indicates a country, state or other region where Identifies the study is taking place. start date and the expected (or actual, depending on status) end date for the study.

A facility in which study activities are conducted.

A full description of how Comments made about the study is being conducted. by the performer, subject or other participants.

Reference to Additional grouping mechanism or categorization of a Group that defines 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 criteria for and quantity of subjects participating classifier element to support existing semantics that are already supported thru explicit elements in the study. E.g. " 200 female Europeans between the ages of 20 and 45 with early onset diabetes". resource.

Sponsors, collaborators, and 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.

The Group referenced should not generally enumerate specific subjects. Subjects will be linked to the study using For a Sponsor or a PrincipalInvestigator use the ResearchSubject resource. dedicated attributes provided.

Name of associated party.

Type of association.

Identifies the start date and the expected (or actual, depending on status) end date for of the study. 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.

An organization that initiates the investigation and is legally responsible A categorization other than role for the study. 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 event or sequence of events for one of the participants subjects of a study. E.g. Exposure 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}.

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 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 study may have multiple distinct outcome measures that can be used to assess the overall goal for a study. The goal of a study is in the objective whereas the metric by which the goal is assessed is the outcomeMeasure. Examples: Time to Local Recurrence (TLR), Disease-free Survival (DFS), 30 Day Mortality, Systolic BP

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.