The Shared Data Model for Research Study represents the understanding of what a Research Study is from the context of users and authors of the NCPI FHIR IG.

External facing, globally unique identifier.

Parent study, required only for substudies.

Name is a repeatable object that consists of sets of two fields. All ResearchStudy records must have at least one Name object with Name.Type=”formal title”.

The study's name

Type of name or title this name relates to (formal-title, internale-name, familiar-name, etc)

short summary of relevant and important information about the study.

A URL for a website that provides information about the research effort as a whole.

Number of total participants represented by the data in this study.

The primary focus(es) of the study. This can include terms related to disease area, intervention, drug, device, or other focus. MeSH terms are preferred.

The term used to describe the focus of the study. A valid MeSH is preferred.

The source ontology or vocabulary for subjectFocus.Term (optional if term uses curie).

EnrollmentCriteria describes the inclusion and exclusion criteria used to enroll participants in this study. This can be provided as a free text description, but may also be structured using bullets, tables, or other organizational methods.

Population is a repeatable object that consists of sets of two fields. Population provides an overall description of the general population enrolled in the study, including basic demographics at a minimum and other useful population descriptors as appropriate.

A term that specifies the population being described.

A free text field that provides more information about the population specified in PopulationType within the context of this researchStudy.

Provide any relevant information regarding how to cite this study. This can be as specific as including a full citation or as simple as a DOI.

Provide a list of publications that use this data. This may be updated to include new publications as they are created.

AdditionalDocumentation should be used to provide URLs, citations, or other appropriate references to technical documentation that is important for understanding the data included in this study. This can include data dictionaries, methods descriptions, github repositories, case report forms (CRFs), or any other relevant documentation.

If the data in this study was gathered as part of a consortial effort, list the consortium here.

Acknowledgements describes any attribution or acknowledgements relevant to the study. This can include but is not limited to funding sources, organizational affiliations or sponsors.

Every study must have at least one Primary Contact defined. Additional personnel such as Primary Investigator(s), Administrator(s), Collaborator(s) or other roles may also be included. If there are no appropriate individuals who can serve as primary contact for a study, an organization may be provided.

The name of the person being described.

The role of the person being described.

The organizational affiliation of the person being described.

The Shared Data Model for Research Study represents the understanding of what a Research Study is from the context of users and authors of the NCPI FHIR IG.

External facing, globally unique identifier.

Parent study, required only for substudies.

Name is a repeatable object that consists of sets of two fields. All ResearchStudy records must have at least one Name object with Name.Type=”formal title”.

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.

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

The study's name

Type of name or title this name relates to (formal-title, internale-name, familiar-name, etc)

short summary of relevant and important information about the study.

A URL for a website that provides information about the research effort as a whole.

Number of total participants represented by the data in this study.

The primary focus(es) of the study. This can include terms related to disease area, intervention, drug, device, or other focus. MeSH terms are preferred.

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.

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

The term used to describe the focus of the study. A valid MeSH is preferred.

The source ontology or vocabulary for subjectFocus.Term (optional if term uses curie).

EnrollmentCriteria describes the inclusion and exclusion criteria used to enroll participants in this study. This can be provided as a free text description, but may also be structured using bullets, tables, or other organizational methods.

Population is a repeatable object that consists of sets of two fields. Population provides an overall description of the general population enrolled in the study, including basic demographics at a minimum and other useful population descriptors as appropriate.

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.

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

A term that specifies the population being described.

A free text field that provides more information about the population specified in PopulationType within the context of this researchStudy.

Provide any relevant information regarding how to cite this study. This can be as specific as including a full citation or as simple as a DOI.

Provide a list of publications that use this data. This may be updated to include new publications as they are created.

AdditionalDocumentation should be used to provide URLs, citations, or other appropriate references to technical documentation that is important for understanding the data included in this study. This can include data dictionaries, methods descriptions, github repositories, case report forms (CRFs), or any other relevant documentation.

If the data in this study was gathered as part of a consortial effort, list the consortium here.

Acknowledgements describes any attribution or acknowledgements relevant to the study. This can include but is not limited to funding sources, organizational affiliations or sponsors.

Every study must have at least one Primary Contact defined. Additional personnel such as Primary Investigator(s), Administrator(s), Collaborator(s) or other roles may also be included. If there are no appropriate individuals who can serve as primary contact for a study, an organization may be provided.

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.

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

The name of the person being described.

The role of the person being described.

The organizational affiliation of the person being described.

The Shared Data Model for Research Study represents the understanding of what a Research Study is from the context of users and authors of the NCPI FHIR IG.

External facing, globally unique identifier.

Parent study, required only for substudies.

Name is a repeatable object that consists of sets of two fields. All ResearchStudy records must have at least one Name object with Name.Type=”formal title”.

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

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.

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.

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

The study's name

Type of name or title this name relates to (formal-title, internale-name, familiar-name, etc)

short summary of relevant and important information about the study.

A URL for a website that provides information about the research effort as a whole.

Number of total participants represented by the data in this study.

The primary focus(es) of the study. This can include terms related to disease area, intervention, drug, device, or other focus. MeSH terms are preferred.

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

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.

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.

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

The term used to describe the focus of the study. A valid MeSH is preferred.

The source ontology or vocabulary for subjectFocus.Term (optional if term uses curie).

EnrollmentCriteria describes the inclusion and exclusion criteria used to enroll participants in this study. This can be provided as a free text description, but may also be structured using bullets, tables, or other organizational methods.

Population is a repeatable object that consists of sets of two fields. Population provides an overall description of the general population enrolled in the study, including basic demographics at a minimum and other useful population descriptors as appropriate.

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

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.

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.

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

A term that specifies the population being described.

A free text field that provides more information about the population specified in PopulationType within the context of this researchStudy.

Provide any relevant information regarding how to cite this study. This can be as specific as including a full citation or as simple as a DOI.

Provide a list of publications that use this data. This may be updated to include new publications as they are created.

AdditionalDocumentation should be used to provide URLs, citations, or other appropriate references to technical documentation that is important for understanding the data included in this study. This can include data dictionaries, methods descriptions, github repositories, case report forms (CRFs), or any other relevant documentation.

If the data in this study was gathered as part of a consortial effort, list the consortium here.

Acknowledgements describes any attribution or acknowledgements relevant to the study. This can include but is not limited to funding sources, organizational affiliations or sponsors.

Every study must have at least one Primary Contact defined. Additional personnel such as Primary Investigator(s), Administrator(s), Collaborator(s) or other roles may also be included. If there are no appropriate individuals who can serve as primary contact for a study, an organization may be provided.

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

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.

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.

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

The name of the person being described.

The role of the person being described.

The organizational affiliation of the person being described.