This profile defines the patient's adverse event clinical research.

Describes an entity that is suspected to have caused the adverse event. (有害事象を引き起こしたと疑われる因子を記述する。)

A contributing factors suspected to have increased the probability or severity of the adverse event. (有害事象の発生確率または重症度を高めたと疑われる要因)

The ameliorating action taken after the adverse event occurred in order to reduce the extent of harm. (有害事象の発生後、被害の程度を軽減するために取られた改善措置)

The current state of the adverse event or potential adverse event. (いかなる規制または品質機関への事象の報告でもない。 これは患者の状態の結果ではない。)

This is not the reporting of the event to any regulatory or quality organization. This is not the outcome of the patient's condition.

Specific event that occurred or that was averted, such as patient fall, wrong organ removed, or wrong blood transfused. (患者の転倒、誤った臓器の摘出、誤った輸血など、発生した、または回避された特定の出来事。)

This profile defines the patient's adverse event clinical research.

The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.

The only time that a resource does not have an id is when it is being submitted to the server using a create operation.

The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource.

A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.

Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of it's narrative along with other profiles, value sets, etc.

The base language in which the resource is written.

Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute).

A human language.

A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety.

Contained resources do not have narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded information is added later.

These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, and nor can they have their own independent transaction scope.

This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags In their meta elements, but SHALL NOT have security labels.

An Extension

Communicates Research Subject related metadata.
研究テーマに関連するメタデータの参照。

Indicates if the subject discontinued the study due to the adverse event.
被験者が有害事象により試験を中止した場合を示す。

Element to capture the presence or absence of specific factors (criteria) associated with serious adverse events.
重篤な有害事象に関連する特定の因子（基準）の有無を把握するための要素。

For cancer related trials, severity is represented as a grade. Describes the grade of the adverse event, in relation to the subject not the resulting condition. In the context of clinical research, it is the investigator’s assessment of severity, in oncology related trials this is reported as grade.
がん関連の試験では、重症度はグレードで表される。有害事象のグレードは、結果として生じた状態ではなく、被験者との関係で記述される。臨床研究の文脈では、治験責任医師による重症度の評価であり、がん関連試験ではグレードとして報告される。

Considered likely or probable or anticipated in the research study. Whether the reported event matches any of the outcomes for the patient that are considered by the study as known or likely.
調査研究で、予想される事象が報告されているかどうか。その事象が、治験で既知のもの、または患者の転帰と一致する可能性が高いかどうか。

Comments made about the adverse event by the performer, subject or other participants.
実施者、被験者、その他の参加者による有害事象に関するコメント。

The date the adverse event was resolved.
有害事象が解決された日時。

Describes an entity that is suspected to have caused the adverse event. (有害事象を引き起こしたと疑われる因子を記述する。)

A contributing factors suspected to have increased the probability or severity of the adverse event. (有害事象の発生確率または重症度を高めたと疑われる要因)

The ameliorating action taken after the adverse event occurred in order to reduce the extent of harm. (有害事象の発生後、被害の程度を軽減するために取られた改善措置)

Relevant past history for the subject. In a clinical care context, an example being a patient had an adverse event following a penicillin administration and the patient had a previously documented penicillin allergy. In a clinical trials context, an example is a bunion or rash that was present prior to the study. Additionally, the supporting item can be a document that is relevant to this instance of the adverse event that is not part of the subject's medical history. For example, a clinical note, staff list, or material safety data sheet (MSDS). Supporting information is not a contributing factor, preventive action, or mitigating action.
被験者に関連する過去の病歴。臨床医療の文脈では、例えば、患者がペニシリン投与後に有害 事象を起こし、その患者が以前にペニシリンアレルギーを記録されたことが ある。臨床試験の文脈では、試験前に存在した外反母趾や発疹が例となる。さらに、補助項目は、被験者の病歴の一部ではない、有害事象のこの例に関連する 文書とすることができる。例えば、臨床記録、スタッフリスト、物質安全性データシート（MSDS）な ど。裏付け情報は、要因、予防措置、緩和措置ではない。

Indicates who or what participated in the adverse event and how they were involved.
誰が、何が、どのように有害事象に関与したかを示す

Information about the condition that occurred as a result of the adverse event.
有害事象の結果として発生した状態に関する情報。

An Extension

The current state of the adverse event or potential adverse event. (いかなる規制または品質機関への事象の報告でもない。 これは患者の状態の結果ではない。)

This is not the reporting of the event to any regulatory or quality organization. This is not the outcome of the patient's condition.

Business identifiers assigned to this adverse event by the performer or other systems which remain constant as the resource is updated and propagates from server to server.

This is a business identifier, not a resource identifier (see discussion). It is best practice for the identifier to only appear on a single resource instance, however business practices may occasionally dictate that multiple resource instances with the same identifier can exist - possibly even with different resource types. For example, multiple Patient and a Person resource instance might share the same social insurance number.

Allows identification of the adverse event as it is known by various participating systems and in a way that remains consistent across servers.

Whether the event actually happened, or just had the potential to. Note that this is independent of whether anyone was affected or harmed or how severely.

Overall nature of the adverse event, e.g. real or potential.

The overall type of event, intended for search and filtering purposes.

Overall categorization of the event, e.g. product-related or situational.

Specific event that occurred or that was averted, such as patient fall, wrong organ removed, or wrong blood transfused. (患者の転倒、誤った臓器の摘出、誤った輸血など、発生した、または回避された特定の出来事。)

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

An Extension

A reference to a code defined by a terminology system.

Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

Allows for alternative encodings within a code system, and translations to other code systems.

A reference to a code defined by a terminology system.

Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

Allows for alternative encodings within a code system, and translations to other code systems.

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

An Extension

The identification of the code system that defines the meaning of the symbol in the code.

The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should reference to some definition that establishes the system clearly and unambiguously.

Need to be unambiguous about the source of the definition of the symbol.

The version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured, and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged.

Where the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date.

A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination).

Need to refer to a particular code in the system.

A representation of the meaning of the code in the system, following the rules of the system.

Need to be able to carry a human-readable meaning of the code for readers that do not know the system.

Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays).

Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely.

This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing.

A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.

Very often the text is the same as a displayName of one of the codings.

The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.

This subject or group impacted by the event.

If AdverseEvent.resultingCondition differs among members of the group, then use Patient as the subject.

Allows for exposure of biohazard (such as legionella) to a group of individuals in a hospital.

The Encounter during which AdverseEvent was created or to which the creation of this record is tightly associated.

This will typically be the encounter the event occurred within, but some activities may be initiated prior to or after the official completion of an encounter but still be tied to the context of the encounter. For example, if a medication administration was considered an adverse event because it resulted in a rash, then the encounter when the medication administration was given is the context. If the patient reports the AdverseEvent during a second encounter, that second encounter is not the context.

The date (and perhaps time) when the adverse event occurred.

Estimated or actual date the AdverseEvent began, in the opinion of the reporter.

The date on which the existence of the AdverseEvent was first recorded.

The recordedDate represents the date when this particular AdverseEvent record was created in the system, not the date of the most recent update. The date of the last record modification can be retrieved from the resource metadata.

Includes information about the reaction that occurred as a result of exposure to a substance (for example, a drug or a chemical).

The information about where the adverse event occurred.

Assessment whether this event was of real importance.

Describes the severity of the adverse event, in relation to the subject. Contrast to AdverseEvent.seriousness - a severe rash might not be serious, but a mild heart problem is.

The severity of the adverse event itself, in direct relation to the subject.

Describes the type of outcome from the adverse event.

Information on who recorded the adverse event. May be the patient or a practitioner.

Parties that may or should contribute or have contributed information to the adverse event, which can consist of one or more activities. Such information includes information leading to the decision to perform the activity and how to perform the activity (e.g. consultant), information that the activity itself seeks to reveal (e.g. informant of clinical history), or information about what activity was performed (e.g. informant witness).

Describes the entity that is suspected to have caused the adverse event.

AdverseEvent.subjectMedicalHistory.

AdverseEvent.referenceDocument.

AdverseEvent.study.

This profile defines the patient's adverse event clinical research.

The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.

The only time that a resource does not have an id is when it is being submitted to the server using a create operation.

The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource.

A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.

Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of it's narrative along with other profiles, value sets, etc.

The base language in which the resource is written.

Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute).

A human language.

A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety.

Contained resources do not have narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded information is added later.

These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, and nor can they have their own independent transaction scope.

This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags In their meta elements, but SHALL NOT have security labels.

An Extension

Communicates Research Subject related metadata.
研究テーマに関連するメタデータの参照。

Indicates if the subject discontinued the study due to the adverse event.
被験者が有害事象により試験を中止した場合を示す。

Element to capture the presence or absence of specific factors (criteria) associated with serious adverse events.
重篤な有害事象に関連する特定の因子（基準）の有無を把握するための要素。

For cancer related trials, severity is represented as a grade. Describes the grade of the adverse event, in relation to the subject not the resulting condition. In the context of clinical research, it is the investigator’s assessment of severity, in oncology related trials this is reported as grade.
がん関連の試験では、重症度はグレードで表される。有害事象のグレードは、結果として生じた状態ではなく、被験者との関係で記述される。臨床研究の文脈では、治験責任医師による重症度の評価であり、がん関連試験ではグレードとして報告される。

Considered likely or probable or anticipated in the research study. Whether the reported event matches any of the outcomes for the patient that are considered by the study as known or likely.
調査研究で、予想される事象が報告されているかどうか。その事象が、治験で既知のもの、または患者の転帰と一致する可能性が高いかどうか。

Comments made about the adverse event by the performer, subject or other participants.
実施者、被験者、その他の参加者による有害事象に関するコメント。

The date the adverse event was resolved.
有害事象が解決された日時。

Describes an entity that is suspected to have caused the adverse event. (有害事象を引き起こしたと疑われる因子を記述する。)

A contributing factors suspected to have increased the probability or severity of the adverse event. (有害事象の発生確率または重症度を高めたと疑われる要因)

The ameliorating action taken after the adverse event occurred in order to reduce the extent of harm. (有害事象の発生後、被害の程度を軽減するために取られた改善措置)

Relevant past history for the subject. In a clinical care context, an example being a patient had an adverse event following a penicillin administration and the patient had a previously documented penicillin allergy. In a clinical trials context, an example is a bunion or rash that was present prior to the study. Additionally, the supporting item can be a document that is relevant to this instance of the adverse event that is not part of the subject's medical history. For example, a clinical note, staff list, or material safety data sheet (MSDS). Supporting information is not a contributing factor, preventive action, or mitigating action.
被験者に関連する過去の病歴。臨床医療の文脈では、例えば、患者がペニシリン投与後に有害 事象を起こし、その患者が以前にペニシリンアレルギーを記録されたことが ある。臨床試験の文脈では、試験前に存在した外反母趾や発疹が例となる。さらに、補助項目は、被験者の病歴の一部ではない、有害事象のこの例に関連する 文書とすることができる。例えば、臨床記録、スタッフリスト、物質安全性データシート（MSDS）な ど。裏付け情報は、要因、予防措置、緩和措置ではない。

Indicates who or what participated in the adverse event and how they were involved.
誰が、何が、どのように有害事象に関与したかを示す

Information about the condition that occurred as a result of the adverse event.
有害事象の結果として発生した状態に関する情報。

An Extension

The current state of the adverse event or potential adverse event. (いかなる規制または品質機関への事象の報告でもない。 これは患者の状態の結果ではない。)

This is not the reporting of the event to any regulatory or quality organization. This is not the outcome of the patient's condition.

Business identifiers assigned to this adverse event by the performer or other systems which remain constant as the resource is updated and propagates from server to server.

This is a business identifier, not a resource identifier (see discussion). It is best practice for the identifier to only appear on a single resource instance, however business practices may occasionally dictate that multiple resource instances with the same identifier can exist - possibly even with different resource types. For example, multiple Patient and a Person resource instance might share the same social insurance number.

Allows identification of the adverse event as it is known by various participating systems and in a way that remains consistent across servers.

Whether the event actually happened, or just had the potential to. Note that this is independent of whether anyone was affected or harmed or how severely.

Overall nature of the adverse event, e.g. real or potential.

The overall type of event, intended for search and filtering purposes.

Overall categorization of the event, e.g. product-related or situational.

Specific event that occurred or that was averted, such as patient fall, wrong organ removed, or wrong blood transfused. (患者の転倒、誤った臓器の摘出、誤った輸血など、発生した、または回避された特定の出来事。)

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

An Extension

A reference to a code defined by a terminology system.

Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

Allows for alternative encodings within a code system, and translations to other code systems.

A reference to a code defined by a terminology system.

Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

Allows for alternative encodings within a code system, and translations to other code systems.

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

An Extension

The identification of the code system that defines the meaning of the symbol in the code.

The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should reference to some definition that establishes the system clearly and unambiguously.

Need to be unambiguous about the source of the definition of the symbol.

The version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured, and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged.

Where the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date.

A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination).

Need to refer to a particular code in the system.

A representation of the meaning of the code in the system, following the rules of the system.

Need to be able to carry a human-readable meaning of the code for readers that do not know the system.

Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays).

Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely.

This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing.

A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.

Very often the text is the same as a displayName of one of the codings.

The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.

This subject or group impacted by the event.

If AdverseEvent.resultingCondition differs among members of the group, then use Patient as the subject.

Allows for exposure of biohazard (such as legionella) to a group of individuals in a hospital.

The Encounter during which AdverseEvent was created or to which the creation of this record is tightly associated.

This will typically be the encounter the event occurred within, but some activities may be initiated prior to or after the official completion of an encounter but still be tied to the context of the encounter. For example, if a medication administration was considered an adverse event because it resulted in a rash, then the encounter when the medication administration was given is the context. If the patient reports the AdverseEvent during a second encounter, that second encounter is not the context.

The date (and perhaps time) when the adverse event occurred.

Estimated or actual date the AdverseEvent began, in the opinion of the reporter.

The date on which the existence of the AdverseEvent was first recorded.

The recordedDate represents the date when this particular AdverseEvent record was created in the system, not the date of the most recent update. The date of the last record modification can be retrieved from the resource metadata.

Includes information about the reaction that occurred as a result of exposure to a substance (for example, a drug or a chemical).

The information about where the adverse event occurred.

Assessment whether this event was of real importance.

Describes the severity of the adverse event, in relation to the subject. Contrast to AdverseEvent.seriousness - a severe rash might not be serious, but a mild heart problem is.

The severity of the adverse event itself, in direct relation to the subject.

Describes the type of outcome from the adverse event.

Information on who recorded the adverse event. May be the patient or a practitioner.

Parties that may or should contribute or have contributed information to the adverse event, which can consist of one or more activities. Such information includes information leading to the decision to perform the activity and how to perform the activity (e.g. consultant), information that the activity itself seeks to reveal (e.g. informant of clinical history), or information about what activity was performed (e.g. informant witness).

Describes the entity that is suspected to have caused the adverse event.

AdverseEvent.subjectMedicalHistory.

AdverseEvent.referenceDocument.

AdverseEvent.study.