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Biomedical Research and Regulation Work Group | Maturity Level: 0 | Trial Use | Security Category: Business | Compartments: Practitioner |
Detailed Descriptions for the elements in the ResearchStudy resource.
ResearchStudy | |
Element Id | ResearchStudy |
Definition | A process where a researcher or organization plans and then executes a series of steps intended to increase the field of healthcare-related knowledge. This includes studies of safety, efficacy, comparative effectiveness and other information about medications, devices, therapies and other interventional and investigative techniques. A ResearchStudy involves the gathering of information about human or animal subjects. |
Cardinality | 0..* |
Type | DomainResource |
Alternate Names | Clinical Trial; Study |
Comments | Need to make sure we encompass public health studies. |
ResearchStudy.identifier | |
Element Id | ResearchStudy.identifier |
Definition | Identifiers assigned to this research study by the sponsor or other systems. |
Note | This is a business identifier, not a resource identifier (see discussion) |
Cardinality | 0..* |
Type | Identifier |
Requirements | Allows identification of the research study as it is known by various participating systems and in a way that remains consistent across servers. |
Summary | true |
ResearchStudy.title | |
Element Id | ResearchStudy.title |
Definition | A short, descriptive user-friendly label for the study. |
Cardinality | 0..1 |
Type | string |
Summary | true |
ResearchStudy.protocol | |
Element Id | ResearchStudy.protocol |
Definition | The set of steps expected to be performed as part of the execution of the study. |
Cardinality | 0..* |
Type | Reference(PlanDefinition) |
Summary | true |
ResearchStudy.partOf | |
Element Id | ResearchStudy.partOf |
Definition | A larger research study of which this particular study is a component or step. |
Cardinality | 0..* |
Type | Reference(ResearchStudy) |
Requirements | Allows breaking a study into components (e.g. by study site) each with their own PI, status, enrollment, etc. |
Alternate Names | container |
Summary | true |
ResearchStudy.status | |
Element Id | ResearchStudy.status |
Definition | The current state of the study. |
Cardinality | 1..1 |
Terminology Binding | ResearchStudyStatus (Required) |
Type | code |
Is Modifier | true (Reason: This element is labeled as a modifier because it is a status element that contains status entered-in-error which means that the resource should not be treated as valid) |
Summary | true |
ResearchStudy.primaryPurposeType | |
Element Id | ResearchStudy.primaryPurposeType |
Definition | The type of study based upon the intent of the study's activities. A classification of the intent of the study. |
Cardinality | 0..1 |
Terminology Binding | ResearchStudyPrimaryPurposeType (Extensible) |
Type | CodeableConcept |
Summary | true |
ResearchStudy.phase | |
Element Id | ResearchStudy.phase |
Definition | The stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation. |
Cardinality | 0..1 |
Terminology Binding | ResearchStudyPhase (Example) |
Type | CodeableConcept |
Summary | true |
ResearchStudy.category | |
Element Id | ResearchStudy.category |
Definition | Codes categorizing the type of study such as investigational vs. observational, type of blinding, type of randomization, safety vs. efficacy, etc. |
Cardinality | 0..* |
Terminology Binding | ResearchStudyCategory: |
Type | CodeableConcept |
Summary | true |
ResearchStudy.focus | |
Element Id | ResearchStudy.focus |
Definition | The medication(s), food(s), therapy(ies), device(s) or other concerns or interventions that the study is seeking to gain more information about. |
Cardinality | 0..* |
Terminology Binding | ResearchStudyFocus: |
Type | CodeableConcept |
Summary | true |
ResearchStudy.condition | |
Element Id | ResearchStudy.condition |
Definition | 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. |
Cardinality | 0..* |
Terminology Binding | Condition/Problem/Diagnosis Codes (Example) |
Type | CodeableConcept |
Summary | true |
ResearchStudy.contact | |
Element Id | ResearchStudy.contact |
Definition | Contact details to assist a user in learning more about or engaging with the study. |
Cardinality | 0..* |
Type | ContactDetail |
Summary | true |
ResearchStudy.relatedArtifact | |
Element Id | ResearchStudy.relatedArtifact |
Definition | Citations, references and other related documents. |
Cardinality | 0..* |
Type | RelatedArtifact |
ResearchStudy.keyword | |
Element Id | ResearchStudy.keyword |
Definition | Key terms to aid in searching for or filtering the study. |
Cardinality | 0..* |
Terminology Binding | ResearchStudyKeyword: |
Type | CodeableConcept |
Summary | true |
ResearchStudy.location | |
Element Id | ResearchStudy.location |
Definition | Indicates a country, state or other region where the study is taking place. |
Cardinality | 0..* |
Terminology Binding | Jurisdiction (Extensible) |
Type | CodeableConcept |
Summary | true |
ResearchStudy.description | |
Element Id | ResearchStudy.description |
Definition | A full description of how the study is being conducted. |
Cardinality | 0..1 |
Type | markdown |
ResearchStudy.enrollment | |
Element Id | ResearchStudy.enrollment |
Definition | Reference to a Group that defines the criteria for and quantity of subjects participating in the study. E.g. " 200 female Europeans between the ages of 20 and 45 with early onset diabetes". |
Cardinality | 0..* |
Type | Reference(Group) |
Alternate Names | patient |
Summary | true |
Comments | The Group referenced should not generally enumerate specific subjects. Subjects will be linked to the study using the ResearchSubject resource. |
ResearchStudy.period | |
Element Id | ResearchStudy.period |
Definition | Identifies the start date and the expected (or actual, depending on status) end date for the study. |
Cardinality | 0..1 |
Type | Period |
Alternate Names | timing |
Summary | true |
ResearchStudy.sponsor | |
Element Id | ResearchStudy.sponsor |
Definition | An organization that initiates the investigation and is legally responsible for the study. |
Cardinality | 0..1 |
Type | Reference(Organization) |
Summary | true |
ResearchStudy.principalInvestigator | |
Element Id | ResearchStudy.principalInvestigator |
Definition | A researcher in a 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. |
Cardinality | 0..1 |
Type | Reference(Practitioner | PractitionerRole) |
Patterns | Reference(Practitioner,PractitionerRole): Common patterns = Participant |
Summary | true |
ResearchStudy.site | |
Element Id | ResearchStudy.site |
Definition | A facility in which study activities are conducted. |
Cardinality | 0..* |
Type | Reference(Location) |
Summary | true |
ResearchStudy.reasonStopped | |
Element Id | ResearchStudy.reasonStopped |
Definition | A description and/or code explaining the premature termination of the study. |
Cardinality | 0..1 |
Terminology Binding | ResearchStudyReasonStopped (Example) |
Type | CodeableConcept |
Summary | true |
ResearchStudy.note | |
Element Id | ResearchStudy.note |
Definition | Comments made about the study by the performer, subject or other participants. |
Cardinality | 0..* |
Type | Annotation |
ResearchStudy.arm | |
Element Id | ResearchStudy.arm |
Definition | 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. |
Cardinality | 0..* |
ResearchStudy.arm.name | |
Element Id | ResearchStudy.arm.name |
Definition | Unique, human-readable label for this arm of the study. |
Cardinality | 1..1 |
Type | string |
ResearchStudy.arm.type | |
Element Id | ResearchStudy.arm.type |
Definition | Categorization of study arm, e.g. experimental, active comparator, placebo comparater. |
Cardinality | 0..1 |
Type | CodeableConcept |
ResearchStudy.arm.description | |
Element Id | ResearchStudy.arm.description |
Definition | A succinct description of the path through the study that would be followed by a subject adhering to this arm. |
Cardinality | 0..1 |
Type | string |
ResearchStudy.objective | |
Element Id | ResearchStudy.objective |
Definition | 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. |
Cardinality | 0..* |
ResearchStudy.objective.name | |
Element Id | ResearchStudy.objective.name |
Definition | Unique, human-readable label for this objective of the study. |
Cardinality | 0..1 |
Type | string |
ResearchStudy.objective.type | |
Element Id | ResearchStudy.objective.type |
Definition | The kind of study objective. |
Cardinality | 0..1 |
Terminology Binding | ResearchStudyObjectiveType (Preferred) |
Type | CodeableConcept |