Atomic Warehouse Model Data Model

Entity

Entity Defined Procedure Detail

Description

An activity defined at a global library level that is an action whose immediate and primary intention is the alteration of the physical condition of the subject, study subject or experimental unit.

For example:
Procedures may involve the disruption of some body surface (for example, an incision in a surgical procedure).
Conservative procedures such as reduction of a luxated joint, including physiotherapy such as chiropractic treatment, massage, balneotherapy, acupuncture, shiatsu.

Attributes
Activity Nm
Activity Sk
Approach Anatomic Site Code Sk
Approach Anatomic Site Laterality Code Sk
Category Code Sk
Comment Txt
Description Txt
Dose Frequency Code Sk
Dose Period Code Sk
Dose Regimen Txt
Duration Qty
Effective From Dt
Effective To Dt
Flow Rt
Identification Num
Load Info Sk
Method Code Sk
Name Code Modified Txt
Period Product Dose Total Qty
Product Dose Qty
Reason Code Sk
Repeat Duration Qty
Repeat Frequency Code Sk
Repeat Frequency Ratio
Route Of Administration Code Sk
Source Code Sk
Status Change Reason Code Sk
Status Code Sk
Status Dt
Subcategory Code Sk
Target Anatomic Site Code Sk
Target Anatomic Site Laterality Code Sk
Tenant Sk
Valid From Ts
Valid To Ts

Relationship
Defined Procedure Detail_Activity_FK

Primary Key
Defined Procedure Detail PK

Dependencies

Reverse Dependencies

Attribute Details

Activity Nm

Description	The text description of an activity within a clinical trial or study.
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

Activity Sk

Description	Surrogate key for the 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

Approach Anatomic Site Code Sk

Description	Identifies the anatomic location or access point for an observation or procedure. Neither target anatomic site nor approach anatomic site is necessarily required or relevant for certain observations, however if either or both are present then the distinction between them is that the approach site is the access point for the measurement or observation and the target site is what is ultimately being evaluated. For example: Anus for a colonoscopy observation Arm for an injection Trans-abdominal for a nephrectomy
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

Approach Anatomic Site Laterality Code Sk

Description	Specifies the side of the body (or a paired organ) that is an access point for an observation or procedure. For example: Bilateral Left Right
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

Category Code Sk

Description	Classification of activities. For example: In the case where Category Code = "anti-cancer treatment", the Sub Category Code may = "radiotherapy" and the Name Code may = "external beam radiotherapy".
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

Comment Txt

Description	Additional description of the activity. For example: Guidance on how to perform the observation.
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

Description Txt

Description	The textual representation of the activity.
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

Dose Frequency Code Sk

Description	Specifies how often doses are administered. Used to capture multiple substance administrations in one act, rather than each time a patient swallows a pill, for example "The patient took med X 3 times a day for 10 days starting on June 9th". For example: BID TID QID
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

Dose Period Code Sk

Description	Specifies the period during which the dose total is administered. For example: Daily Course
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

Dose Regimen Txt

Description	Text description of the intended schedule for administering a substance. For example: 2 weeks on, 2 weeks off This represents the dosing calendar in a text format. This is a non-computational description that may need to be expanded as additional use cases arise.
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

Duration Qty

Description	The intended period of time for the planned activity as defined by the study. For example: 6 weeks may be the planned duration for a composite activity that represents the activities occurring during an epoch on arm A.
Data Type	Standards - Data Domains.ddm/Data Domains/Quantity Integer [INTEGER]
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

Flow Rt

Description	A ratio specifying the speed with which the substance is introduced into the subject. For example: 100 mL/h 1 g/d 40 mmol/h
Data Type	Standards - Data Domains.ddm/Data Domains/Rate [FLOAT(5)]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Identification Num

Description	A unique symbol that establishes identity of an activity. For example: 12345 is the identifier for a substance administration
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

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

Method Code Sk

Description	Specifies the technique that is used for the procedure. For example: Finger stick Veni puncture Abdominal/ ascites effusion Biopsy Bronchial alveolar lavage (BAL) Open Laparoscopic
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

Name Code Modified Txt

Description	A character string that is a revision of the original text of the procedure to enable the coding of the text. For example: If the original text is "message", the Name Code Modified Text could be set to "massage", so that the text can be successfully coded.
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

Period Product Dose Total Qty

Description	Total of all doses of this agent in a given period of time. The given period of time is defined in Dose Period. This is needed because the dose may not always be derivable, for example, if it is a string, and because it is often used as a cross-check on dose to ensure mistakes are not made in dosing subjects.
Data Type	Standards - Data Domains.ddm/Data Domains/Quantity Integer [INTEGER]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Product Dose Qty

Description	The quantity of a substance or medication to be administered. For example: 5 mg 20 mg of drug per kg of subject weight
Data Type	Standards - Data Domains.ddm/Data Domains/Quantity Integer [INTEGER]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Reason Code Sk

Description	A coded value specifying the motivation, cause, or rationale of an activity. For example: Routine requirement Drug reaction Infectious disease reporting requirement On 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

Repeat Duration Qty

Description	The period of time over which the activity is repeated.
Data Type	Standards - Data Domains.ddm/Data Domains/Quantity Integer [INTEGER]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Repeat Frequency Code Sk

Description	The repeating frequency with which the treatment is to be administered. It is similar to the frequency and SIG code tables used in order entry systems.
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

Repeat Frequency Ratio

Description	A ratio representing the number of occurrences of an activity within a given time period. For example: Once per 12 hours 2 times per day
Data Type	Standards - Data Domains.ddm/Data Domains/Ratio [FLOAT(5)]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Route Of Administration Code Sk

Description	Identifies the route of administration. For example: Apply Externally Buccal Dental Intravenous Oral Intra-arterial
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 Change Reason Code Sk

Description	Specifies why the status has changed.
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

Status Code Sk

Description	Indicates the phase in the lifecycle of the activity as part of a global library. For example: Draft New Released Retired Archived
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

Status Dt

Description	The date and time the status for an activity as part of a study or clinical trial is defined.
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

Subcategory Code Sk

Description	Specifies a subdivision within a larger category of activities. For example: Chemotherapy Radiotherapy Hormonal therapy Alternative therapy
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

Target Anatomic Site Code Sk

Description	Specifies the anatomic location that is the focus of the observation, procedure, study or result. The target site of an observation result may be different than the target site of the observation that generated it. For instance, the target site of the observation may be broad (for example, skin) while the target site of the observation result is specific (for example, skin on chest). Multiple contiguous sites within the same organ system may be referenced. For example: Lower intestine Arm Breast Ovary Kidney
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

Target Anatomic Site Laterality Code Sk

Description	Specifies the side of the body (or a paired organ) that is a target site for an observation. For example: Bilateral Left Right
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

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

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

Defined Procedure Detail_Activity_FK

Is Identifying Relationship	true
Child Table	Defined Procedure 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	Activity
Parent Multiplicity	ONE
Parent Referential Integrity: On Delete	NONE
Parent Referential Integrity: On Insert	NONE
Parent Referential Integrity: On Update	NONE

Primary Key Details

Defined Procedure Detail PK

Key Attribute	Activity Sk
Key Attribute	Valid From Ts

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Atomic Warehouse Model Data Model