Resource type: researchstudy

Description

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.

Elements

PathShortDefinitionComments
Investigation to increase healthcare-related patient-independent knowledgeA 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.Need to make sure we encompass public health studies.
identifierBusiness Identifier for studyIdentifiers assigned to this research study by the sponsor or other systems.
titleName for this studyA short, descriptive user-friendly label for the study.
protocolSteps followed in executing studyThe set of steps expected to be performed as part of the execution of the study.
partOfPart of larger studyA larger research study of which this particular study is a component or step.
statusactive | administratively-completed | approved | closed-to-accrual | closed-to-accrual-and-intervention | completed | disapproved | in-review | temporarily-closed-to-accrual | temporarily-closed-to-accrual-and-intervention | withdrawnThe current state of the study.
primaryPurposeTypetreatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibilityThe type of study based upon the intent of the study's activities. A classification of the intent of the study.
phasen-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4The stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation.
categoryClassifications for the studyCodes categorizing the type of study such as investigational vs. observational, type of blinding, type of randomization, safety vs. efficacy, etc.
focusDrugs, devices, etc. under studyThe medication(s), food(s), therapy(ies), device(s) or other concerns or interventions that the study is seeking to gain more information about.
conditionCondition being studiedThe 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.
contactContact details for the studyContact details to assist a user in learning more about or engaging with the study.
relatedArtifactReferences and dependenciesCitations, references and other related documents.
keywordUsed to search for the studyKey terms to aid in searching for or filtering the study.
locationGeographic region(s) for studyIndicates a country, state or other region where the study is taking place.
descriptionWhat this is study doingA full description of how the study is being conducted.
enrollmentInclusion & exclusion criteriaReference 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".The Group referenced should not generally enumerate specific subjects. Subjects will be linked to the study using the ResearchSubject resource.
periodWhen the study began and endedIdentifies the start date and the expected (or actual, depending on status) end date for the study.
sponsorOrganization that initiates and is legally responsible for the studyAn organization that initiates the investigation and is legally responsible for the study.
principalInvestigatorResearcher who oversees multiple aspects of the studyA 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.
siteFacility where study activities are conductedA facility in which study activities are conducted.
reasonStoppedaccrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-closed-per-study-designA description and/or code explaining the premature termination of the study.
noteComments made about the studyComments made about the study by the performer, subject or other participants.
armDefined path through the study for a subjectDescribes 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.
arm.idUnique id for inter-element referencingUnique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
arm.extensionAdditional content defined by implementationsMay be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
arm.modifierExtensionExtensions that cannot be ignored even if unrecognizedMay be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
arm.nameLabel for study armUnique, human-readable label for this arm of the study.
arm.typeCategorization of study armCategorization of study arm, e.g. experimental, active comparator, placebo comparater.
arm.descriptionShort explanation of study pathA succinct description of the path through the study that would be followed by a subject adhering to this arm.
objectiveA goal for the studyA 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.
objective.idUnique id for inter-element referencingUnique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
objective.extensionAdditional content defined by implementationsMay be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
objective.modifierExtensionExtensions that cannot be ignored even if unrecognizedMay be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
objective.nameLabel for the objectiveUnique, human-readable label for this objective of the study.
objective.typeprimary | secondary | exploratoryThe kind of study objective.


Scope and Usage

This resource is an definition resource from a FHIR workflow perspective - see Workflow.

A research study is a scientific way to improve or develop new methods of health care. Studies are designed to answer specific questions on how to prevent, diagnose, or treat diseases and disorders. The ResearchStudy resource describes essential information about the study, including the purpose, objective, sponsor, investigator, therapy, condition being studied, schedule of activities, and other key items.

Uses for the ResearchStudy resource include:



ResearchStudy State Machine

The following diagram reflects the "typical" state machine for ResearchStudy.

Diagram showing typical state machine for the ResearchStudy resource

Search Parameters

categoryClassifications for the studyResearchStudy.category
dateWhen the study began and endedResearchStudy.period
focusDrugs, devices, etc. under studyResearchStudy.focus
identifierBusiness Identifier for studyResearchStudy.identifier
keywordUsed to search for the studyResearchStudy.keyword
locationGeographic region(s) for studyResearchStudy.location
partofPart of larger studyResearchStudy.partOf
principalinvestigatorResearcher who oversees multiple aspects of the studyResearchStudy.principalInvestigator
protocolSteps followed in executing studyResearchStudy.protocol
siteFacility where study activities are conductedResearchStudy.site
sponsorOrganization that initiates and is legally responsible for the studyResearchStudy.sponsor
statusactive | administratively-completed | approved | closed-to-accrual | closed-to-accrual-and-intervention | completed | disapproved | in-review | temporarily-closed-to-accrual | temporarily-closed-to-accrual-and-intervention | withdrawnResearchStudy.status
titleName for this studyResearchStudy.title

Extension Definitions

These are extension definitions for this resource defined by the spec