Atomic Warehouse Model Data Model

Entity

Entity Consent Detail

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.

Attributes
Blood Product Refusal Ind
Comfort Measures Only Ind
Competency Ind
Competency Txt
Consent Bypass Reason Code Sk
Consent Disclosure Level Code Sk
Consent Effective From Ts
Consent Effective To Ts
Consent Non-Disclosure Reason Code Sk
Consent Purpose Code Sk
Consent Sk
Consent Type Code Sk
Decision Ts
Discussion Ts
Effective From Dt
Effective To Dt
Form Code Sk
Form Identification Num
Informational Material Provided Ind
Life Support Ind
Load Info Sk
Mode Code Sk
Non-Subject Consenter Reason Code Sk
Source Code Sk
Status Code Sk
Study Approval Authority Nm
Study Approval Dt
Study Opt Out Dt
Tenant Sk
Translated Language Code Sk
Translator Ind
Tube Feeding Ind
Valid From Ts
Valid To Ts

Relationship
Consent Detail_Consent_FK

Primary Key
Consent Detail PK

Dependencies

Reverse Dependencies

Attribute Details

Blood Product Refusal Ind

Description	Indicates that the patient should or should not receive blood products.
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

Comfort Measures Only Ind

Description	Indicates that comfort measures should be the only care provided.
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 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 Code Sk

Description	Identifies why the subject's consent was not sought. For example: Emergency Professional Judgment
Data Type	Standards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Consent Disclosure Level Code Sk

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/Surrogate Key [INTEGER]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Consent Effective From Ts

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 Effective To Ts

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 Non-Disclosure Reason Code Sk

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/Surrogate Key [INTEGER]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Consent Purpose Code Sk

Description	The purpose of the consent. For example: Copy of Record Legal Review Insurance Review
Data Type	Standards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Consent Sk

Description	Surrogate key for the Consent anchor entity.
Data Type	Standards - Data Domains.ddm/Data Domains/Surrogate Key Large [LONG]
Is Part Of PrimaryKey	true
Is Required	true
Is Derived	false
Is Surrogate Key	false

Consent Type Code Sk

Description	Described the type of consent provided. For example: Expressed Implied Third Party
Data Type	Standards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Decision Ts

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

Discussion Ts

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

Effective From Dt

Description	Establishes a period where a set of attributes are true according to the business.
Data Type	Standards - Data Domains.ddm/Data Domains/Date [DATE]
Is Part Of PrimaryKey	false
Is Required	true
Is Derived	false
Is Surrogate Key	false

Effective To Dt

Description	Ends a period of effectivity.
Data Type	Standards - Data Domains.ddm/Data Domains/Date [DATE]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Form Code Sk

Description	Indicates the form identifier that was used to record the consent.
Data Type	Standards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
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

Life Support Ind

Description	Indicates that life support should or should not be used.
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

Load Info Sk

Description	The surrogate key of the load information entry describing the details regarding the loading of the row.
Data Type	Standards - Data Domains.ddm/Data Domains/Surrogate Key Large [LONG]
Is Part Of PrimaryKey	false
Is Required	true
Is Derived	false
Is Surrogate Key	false

Mode Code Sk

Description	Describes the form in which the consent was provided. For example: Verbal Written Implied
Data Type	Standards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Non-Subject Consenter Reason Code Sk

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/Surrogate Key [INTEGER]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Source Code Sk

Description	The origin of the data identifying the actual load source, vendor, manual key entry, or context of the data in a specific row in the database.
Data Type	Standards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKey	false
Is Required	true
Is Derived	false
Is Surrogate Key	false

Status Code Sk

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/Surrogate Key [INTEGER]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Study Approval Authority Nm

Description	The approval authority that approved the consent for use in the study.
Data Type	Standards - Data Domains.ddm/Data Domains/Name [VARCHAR(30)]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Study Approval Dt

Description	The date upon which the consent was approved as appropriate for the study.
Data Type	Standards - Data Domains.ddm/Data Domains/Date [DATE]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Study Opt Out Dt

Description	The date upon which the patient opted out of a study.
Data Type	Standards - Data Domains.ddm/Data Domains/Date [DATE]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Tenant Sk

Description	The surrogate key of the entry identifying the legal owner of the data.
Data Type	Standards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKey	false
Is Required	true
Is Derived	false
Is Surrogate Key	false

Translated Language Code Sk

Description	Identifies the language the consent material must be translated to.
Data Type	Standards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
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

Tube Feeding Ind

Description	Indicates that a feeding tube should or should not be used.
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

Valid From Ts

Description	Establishes a period where a set of attributes are true in the source system. This would be populated with the transaction timestamp and would be used for the snapshot date.
Data Type	Standards - Data Domains.ddm/Data Domains/Timestamp [TIMESTAMP]
Is Part Of PrimaryKey	true
Is Required	true
Is Derived	false
Is Surrogate Key	false

Valid To Ts

Description	Ends a period of validity.
Data Type	Standards - Data Domains.ddm/Data Domains/Timestamp [TIMESTAMP]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Relationship Details

Consent Detail_Consent_FK

Is Identifying Relationship	true
Child Table	Consent Detail
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	Consent
Parent Multiplicity	ONE
Parent Referential Integrity: On Delete	NONE
Parent Referential Integrity: On Insert	NONE
Parent Referential Integrity: On Update	NONE

Primary Key Details

Consent Detail PK

Key Attribute	Consent Sk
Key Attribute	Valid From Ts

Overview

Top

Package

Entity

Atomic Warehouse Model Data Model