| Business Data Model Data Model |
| Description | A record that tracks approval by a patient or authorized representative to participate in clinical studies, procedures, examinations, and other activities. Also includes approvals for the release of personal information. |
| Relationship | |
 Patient Consent_Practitioner_FK |
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| Patient Consent_Patient_FK |
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| Patient Consent_Witness_FK |
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| Consent_Encounter_FK |
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| Consent_Provider_FK |
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| Consent_Interpreter_FK |
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| Dependencies | |
 NONE |
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| Reverse Dependencies | |
| |
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| Attribute Details |
Competency Ind
| Description | Identifies whether the subject was deemed competent to provide consent. |
| Data Type | Standards - Data Domains.ddm/Data Domains/Boolean Indicator [INTEGER] |
| Is Part Of PrimaryKey | false |
| Is Required | false |
| Is Derived | false |
| Is Surrogate Key | false |
Competency Txt
| Description | Contains a description of circumstances surrounding subject competency. |
| Data Type | Standards - Data Domains.ddm/Data Domains/Text Large [VARCHAR(1024)] |
| Is Part Of PrimaryKey | false |
| Is Required | false |
| Is Derived | false |
| Is Surrogate Key | false |
Consent Bypass Reason
| Description | Identifies why the subject's consent was not sought. For example: Emergency Professional Judgment |
| Data Type | Standards - Data Domains.ddm/Data Domains/Enumeration [VARCHAR(20)] |
| Is Part Of PrimaryKey | false |
| Is Required | false |
| Is Derived | false |
| Is Surrogate Key | false |
Consent Decision Date and Time
| Description | The date and time upon which the consent decision was made. |
| Data Type | Standards - Data Domains.ddm/Data Domains/Date Time [TIMESTAMP] |
| Is Part Of PrimaryKey | false |
| Is Required | false |
| Is Derived | false |
| Is Surrogate Key | false |
Consent Disclosure Level
| Description | Identifies how much information was disclosed to the subject as part of the informed consent process. For example: Full Disclosure Partial Disclosure No Disclosure |
| Data Type | Standards - Data Domains.ddm/Data Domains/Enumeration [VARCHAR(20)] |
| Is Part Of PrimaryKey | false |
| Is Required | false |
| Is Derived | false |
| Is Surrogate Key | false |
Consent Discussion Date and Time
| Description | Identifies the date and time upon which the consent was discussed with the subject. |
| Data Type | Standards - Data Domains.ddm/Data Domains/Date Time [TIMESTAMP] |
| Is Part Of PrimaryKey | false |
| Is Required | false |
| Is Derived | false |
| Is Surrogate Key | false |
Consent End Date and Time
| Description | The date and time upon which the consent expires. |
| Data Type | Standards - Data Domains.ddm/Data Domains/Date Time [TIMESTAMP] |
| Is Part Of PrimaryKey | false |
| Is Required | false |
| Is Derived | false |
| Is Surrogate Key | false |
Consent Form Identifier
| Description | Indicates the form identifier that was used to record the consent. |
| Data Type | Standards - Data Domains.ddm/Data Domains/Enumeration [VARCHAR(20)] |
| Is Part Of PrimaryKey | false |
| Is Required | false |
| Is Derived | false |
| Is Surrogate Key | false |
Consent Mode
| Description | Describes the form in which the consent was provided. For example: Verbal Written Implied |
| Data Type | Standards - Data Domains.ddm/Data Domains/Enumeration [VARCHAR(20)] |
| Is Part Of PrimaryKey | false |
| Is Required | false |
| Is Derived | false |
| Is Surrogate Key | false |
Consent Non-Disclosure Reason
| Description | Identifies why the subject did not receive full disclosure. For example: Emergency Rx Private Patient Request |
| Data Type | Standards - Data Domains.ddm/Data Domains/Enumeration [VARCHAR(20)] |
| Is Part Of PrimaryKey | false |
| Is Required | false |
| Is Derived | false |
| Is Surrogate Key | false |
Consent Purpose
| Description | The purpose of the consent. For example: Copy of Record Legal Review Insurance Review |
| Data Type | Standards - Data Domains.ddm/Data Domains/Enumeration [VARCHAR(20)] |
| Is Part Of PrimaryKey | false |
| Is Required | false |
| Is Derived | false |
| Is Surrogate Key | false |
Consent Start Date and Time
| Description | The date and time upon which the consent commences from. |
| Data Type | Standards - Data Domains.ddm/Data Domains/Date Time [TIMESTAMP] |
| Is Part Of PrimaryKey | false |
| Is Required | false |
| Is Derived | false |
| Is Surrogate Key | false |
Consent Status
| Description | Indicates whether the consent has been sought and granted. For example: Active – Consent has been granted Limited – Consent has been granted with limitations Refused – Consent has been refused Pending – Consent has not yet been sought Rescinded – Consent was initially granted, but was subsequently revoked or ended. Bypassed – Consent not sought |
| Data Type | Standards - Data Domains.ddm/Data Domains/Enumeration [VARCHAR(20)] |
| Is Part Of PrimaryKey | false |
| Is Required | false |
| Is Derived | false |
| Is Surrogate Key | false |
Consent Translated Language
| Description | Identifies the language the consent material must be translated to. |
| Data Type | Standards - Data Domains.ddm/Data Domains/Enumeration [VARCHAR(20)] |
| Is Part Of PrimaryKey | false |
| Is Required | false |
| Is Derived | false |
| Is Surrogate Key | false |
Consent Type
| Description | The type of consent provided. For example: Expressed Implied Third Party |
| Data Type | Standards - Data Domains.ddm/Data Domains/Enumeration [VARCHAR(20)] |
| Is Part Of PrimaryKey | false |
| Is Required | false |
| Is Derived | false |
| Is Surrogate Key | false |
Form Identification Num
| Description | Indicates the unique identifier of the instance of the consent form. |
| Data Type | Standards - Data Domains.ddm/Data Domains/Alphanumeric [VARCHAR(80)] |
| Is Part Of PrimaryKey | false |
| Is Required | false |
| Is Derived | false |
| Is Surrogate Key | false |
Informational Material Provided Ind
| Description | Identifies whether additional educational or reference material was provided to the subject as part of the consent process. |
| Data Type | Standards - Data Domains.ddm/Data Domains/Boolean Indicator [INTEGER] |
| Is Part Of PrimaryKey | false |
| Is Required | false |
| Is Derived | false |
| Is Surrogate Key | false |
Non-Subject Consenter Reason
| Description | Identifies why the consent was granted by a person other than the subject of the consent. For example: Subject is a minor Subject is not competent to consent Legally mandated |
| Data Type | Standards - Data Domains.ddm/Data Domains/Enumeration [VARCHAR(20)] |
| Is Part Of PrimaryKey | false |
| Is Required | false |
| Is Derived | false |
| Is Surrogate Key | false |
Translator Ind
| Description | Identifies whether translation was (or will be) required to obtain informed consent from the subject. |
| Data Type | Standards - Data Domains.ddm/Data Domains/Boolean Indicator [INTEGER] |
| Is Part Of PrimaryKey | false |
| Is Required | false |
| Is Derived | false |
| Is Surrogate Key | false |
| Relationship Details |
Patient Consent_Practitioner_FK
| Is Identifying Relationship | false |
| Child Table | Consent |
| Child Role Name | recording |
| Child Multiplicity | ZERO_TO_MANY |
| Child Referential Integrity: On Delete | NONE |
| Child Referential Integrity: On Insert | NONE |
| Child Referential Integrity: On Update | NONE |
| Parent Table | Practitioner |
| Parent Multiplicity | ZERO_TO_ONE |
| Parent Referential Integrity: On Delete | NONE |
| Parent Referential Integrity: On Insert | NONE |
| Parent Referential Integrity: On Update | NONE |
Patient Consent_Patient_FK
| Is Identifying Relationship | false |
| Child Table | Consent |
| Child Multiplicity | ZERO_TO_MANY |
| Child Referential Integrity: On Delete | NONE |
| Child Referential Integrity: On Insert | NONE |
| Child Referential Integrity: On Update | NONE |
| Parent Table | Patient |
| Parent Multiplicity | ZERO_TO_ONE |
| Parent Referential Integrity: On Delete | NONE |
| Parent Referential Integrity: On Insert | NONE |
| Parent Referential Integrity: On Update | NONE |
Patient Consent_Witness_FK
| Is Identifying Relationship | false |
| Child Table | Consent |
| Child Multiplicity | ONE_TO_MANY |
| Child Referential Integrity: On Delete | NONE |
| Child Referential Integrity: On Insert | NONE |
| Child Referential Integrity: On Update | NONE |
| Parent Table | Witness |
| Parent Multiplicity | ZERO_TO_MANY |
| Parent Referential Integrity: On Delete | NONE |
| Parent Referential Integrity: On Insert | NONE |
| Parent Referential Integrity: On Update | NONE |
Consent_Encounter_FK
| Is Identifying Relationship | false |
| Child Table | Consent |
| Child Multiplicity | ZERO_TO_MANY |
| Child Referential Integrity: On Delete | NONE |
| Child Referential Integrity: On Insert | NONE |
| Child Referential Integrity: On Update | NONE |
| Parent Table | Encounter |
| Parent Multiplicity | ZERO_TO_ONE |
| Parent Referential Integrity: On Delete | NONE |
| Parent Referential Integrity: On Insert | NONE |
| Parent Referential Integrity: On Update | NONE |
Consent_Provider_FK
| Is Identifying Relationship | true |
| Child Table | Consent |
| Child Multiplicity | ZERO_TO_MANY |
| Child Referential Integrity: On Delete | NONE |
| Child Referential Integrity: On Insert | NONE |
| Child Referential Integrity: On Update | NONE |
| Parent Table | Provider |
| Parent Multiplicity | ONE |
| Parent Referential Integrity: On Delete | NONE |
| Parent Referential Integrity: On Insert | NONE |
| Parent Referential Integrity: On Update | NONE |
Consent_Interpreter_FK
| Is Identifying Relationship | false |
| Child Table | Consent |
| Child Multiplicity | ZERO_TO_MANY |
| Child Referential Integrity: On Delete | NONE |
| Child Referential Integrity: On Insert | NONE |
| Child Referential Integrity: On Update | NONE |
| Parent Table | Care Team Member |
| Parent Multiplicity | ZERO_TO_ONE |
| Parent Referential Integrity: On Delete | NONE |
| Parent Referential Integrity: On Insert | NONE |
| Parent Referential Integrity: On Update | NONE |
| Business Data Model Data Model |