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 type of relationship to the 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 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.

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 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.

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

Indicates a country, state or other region where the A facility in which study is taking place. activities are conducted.

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

A full description Additional grouping mechanism or categorization of how 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 study is being conducted. classifier element to support existing semantics that are already supported thru explicit elements in the resource.

Sponsors, collaborators, and other parties.

Reference to a Group that defines the criteria While there are explicit attributes for a Sponsor and quantity a PrincipalInvestigator many trial record a range of subjects participating other organizations and individuals in key roles.

For a Sponsor or a PrincipalInvestigator use the study. E.g. " 200 female Europeans between the ages dedicated attributes provided.

Name of 20 and 45 with early onset diabetes". 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.

Target or actual group of participants enrolled in study.

Estimated total number of participants to be enrolled.

Comments made about the 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 other participants. '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.

Unique, human-readable label for this arm Estimated total number of participants to be enrolled in the study. comparison group.

Categorization Actual total number of study arm, e.g. experimental, active comparator, placebo comparater. 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'.

A succinct description Group of participants who were enrolled in the path through comparison group as a subset of those enrolled in the study that would be followed by overall study. The referenced Group Resource should have a subject adhering to this arm. 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 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 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.