Path | Short | Definition | Comments |
---|---|---|---|
Investigation to increase healthcare-related patient-independent knowledge | 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. | Need to make sure we encompass public health studies. | |
identifier | Business Identifier for study | Identifiers assigned to this research study by the sponsor or other systems. | |
title | Name for this study | A short, descriptive user-friendly label for the study. | |
protocol | Steps followed in executing study | The set of steps expected to be performed as part of the execution of the study. | |
partOf | Part of larger study | A larger research study of which this particular study is a component or step. | |
status | active | 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completed | disapproved | in-review | temporarily-closed-to-accrual | temporarily-closed-to-accrual-and-intervention | withdrawn | The current state of the study. | |
primaryPurposeType | treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility | The type of study based upon the intent of the study's activities. A classification of the intent of the study. | |
phase | n-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4 | The stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation. | |
category | Classifications for the study | Codes categorizing the type of study such as investigational vs. observational, type of blinding, type of randomization, safety vs. efficacy, etc. | |
focus | Drugs, devices, etc. under study | The medication(s), food(s), therapy(ies), device(s) or other concerns or interventions that the study is seeking to gain more information about. | |
condition | Condition being studied | 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 | Contact details for the study | Contact details to assist a user in learning more about or engaging with the study. | |
relatedArtifact | References and dependencies | Citations, references and other related documents. | |
keyword | Used to search for the study | Key terms to aid in searching for or filtering the study. | |
location | Geographic region(s) for study | Indicates a country, state or other region where the study is taking place. | |
description | What this is study doing | A full description of how the study is being conducted. | |
enrollment | Inclusion & exclusion criteria | 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". | The Group referenced should not generally enumerate specific subjects. Subjects will be linked to the study using the ResearchSubject resource. |
period | When the study began and ended | Identifies the start date and the expected (or actual, depending on status) end date for the study. | |
sponsor | Organization that initiates and is legally responsible for the study | An organization that initiates the investigation and is legally responsible for the study. | |
principalInvestigator | Researcher who oversees multiple aspects of the study | 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. | |
site | Facility where study activities are conducted | A facility in which study activities are conducted. | |
reasonStopped | accrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-closed-per-study-design | A description and/or code explaining the premature termination of the study. | |
note | Comments made about the study | Comments made about the study by the performer, subject or other participants. | |
arm | Defined path through the study for a subject | 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. | |
arm.id | Unique id for inter-element referencing | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. | |
arm.extension | Additional content defined by implementations | May 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.modifierExtension | Extensions that cannot be ignored even if unrecognized | May 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.name | Label for study arm | Unique, human-readable label for this arm of the study. | |
arm.type | Categorization of study arm | Categorization of study arm, e.g. experimental, active comparator, placebo comparater. | |
arm.description | Short explanation of study path | A succinct description of the path through the study that would be followed by a subject adhering to this arm. | |
objective | A goal for the study | 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. | |
objective.id | Unique id for inter-element referencing | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. | |
objective.extension | Additional content defined by implementations | May 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.modifierExtension | Extensions that cannot be ignored even if unrecognized | May 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.name | Label for the objective | Unique, human-readable label for this objective of the study. | |
objective.type | primary | secondary | exploratory | The kind of study objective. |
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:
The following diagram reflects the "typical" state machine for ResearchStudy.
category | Classifications for the study | ResearchStudy.category |
date | When the study began and ended | ResearchStudy.period |
focus | Drugs, devices, etc. under study | ResearchStudy.focus |
identifier | Business Identifier for study | ResearchStudy.identifier |
keyword | Used to search for the study | ResearchStudy.keyword |
location | Geographic region(s) for study | ResearchStudy.location |
partof | Part of larger study | ResearchStudy.partOf |
principalinvestigator | Researcher who oversees multiple aspects of the study | ResearchStudy.principalInvestigator |
protocol | Steps followed in executing study | ResearchStudy.protocol |
site | Facility where study activities are conducted | ResearchStudy.site |
sponsor | Organization that initiates and is legally responsible for the study | ResearchStudy.sponsor |
status | active | 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 | withdrawn | ResearchStudy.status |
title | Name for this study | ResearchStudy.title |