A process where a researcher or organization plans and then executes research study is a series of steps intended scientific investigation designed to increase the field of healthcare-related generate health-related knowledge. This includes studies can include clinical trials involving human participants (or animals in the case of safety, efficacy, comparative effectiveness and other information about medications, devices, therapies and other interventional veterinary clinical trials). These studies may be related to new ways to screen, prevent, diagnose, and investigative techniques. A ResearchStudy involves treat disease. Research studies may also analyze data collected from individuals in the gathering of information about human past (retrospective studies) or animal subjects. future (prospective studies) to understand specific outcomes or trends in particular populations.

Need to make sure we encompass The ResearchStudy Resource may be used for any type of research study, such as public health studies. studies evaluating populations or systematic reviews evaluating research studies, and is not limited to clinical trials or limited to studies of individual people.

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.

A short, descriptive user-friendly label Additional names for the study.

Kind of name.

The name.

Used to express the specific language of the title.

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.

Display of the bibliographic citation of this ResearchStudy.

Relationships that this ResearchStudy has with other FHIR or non-FHIR resources that already exist.

The current state type of relationship to the study. related artifact.

The artifact that is related to this ResearchStudy Resource.

A targetReference using a DocumentReference allows providing metadata regarding the referenced document.

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).

Codes categorizing the The type of study such as investigational vs. observational, type based upon the intent of blinding, type the study activities. A classification of randomization, safety vs. efficacy, etc. the intent of the study.

The condition(s), medication(s), food(s), therapy(ies), device(s) or other concerns or interventions that stage in the study is seeking progression of a therapy from initial experimental use in humans in clinical trials to gain more information about. post-market evaluation.

Contact details to assist a user in learning more about or engaging with Codes categorizing the study. type of study such as investigational vs. observational, type of blinding, type of randomization, safety vs. efficacy, etc.

See the Evidence Based Medicine on FHIR Implementation Guide (https://hl7.org/fhir/uv/ebm) for Extensible and Preferred value sets for evidence-related terminologies.

Citations, references and The medication(s), food(s), therapy(ies), device(s) or other related documents. 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.

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

A categorization other than role for the type of event]. associated party.

The Individual or organization responsible for the execution of the study. associated with study (use practitionerRole to specify their organisation).

Suggestions of a better attribute name are appreciated

Indicates the individual who has primary oversite of the execution Status of the study. study with time for that status.

Label for status or state (e.g. recruitment status).

Clinic, hospital An indication of whether or other healthcare location that not the date is participating in a known date when the study. 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.

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

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.

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 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 arm objective of the study.

Categorization The kind of study arm, e.g. experimental, active comparator, placebo comparater. objective.

A succinct Free text description of the path through 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 would can be followed by used to assess the overall goal for a subject adhering 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 arm. estimand.

Comparison group of interest.

To re-use and reference a Group represented in ResearchStudy.comparisonGroup.eligibility, one may include the Group Resource in ResearchStudy.contained and then reference the same (internal) Group by its id

Comparison group for comparison.

To re-use and reference a Group represented in ResearchStudy.comparisonGroup.eligibility, one may include the Group Resource in ResearchStudy.contained and then reference the same (internal) Group by its id

Statistical measure for treatment effect estimate.

See the Evidence Based Medicine on FHIR Implementation Guide (https://hl7.org/fhir/uv/ebm) for Extensible and Preferred value sets for evidence-related terminologies.

The planned statistical model for analysis of a single endpoint.

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.