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.

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).

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 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.

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 dedicated attributes provided.

Name of associated party.

Type of association.

Identifies the start date and the 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.

Individual or organization associated with study (use practitionerRole to specify their organisation).

Suggestions of a better attribute name are appreciated

Status of study 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.

Target or 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. 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'.

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}.

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.

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'.

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 measure.

The kind of outcome measure.

Description of the outcome measure.

Definition of the outcome measure.

Population for this estimand.

Comparison group of interest.

To do: How to refernece internally to the comparisonGroup.id

Comparison group for comparison.

To do: How to refernece internally to the comparisonGroup.id

Statistical measure for treatment effect estimate.

Handling of intercurrent event.

The event.

The group that is affected by this event handling.

How the data is handled.

Text summary of event handling.

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.