Atomic Warehouse Model Data Model

Entity

Entity Substance Administration Detail

Description

A performed activity that applies, introduces or otherwise gives medications or other substances to the subject or experimental unit.

For example:
An experimental unit who receives methotrexate as part of chemotherapy, radiation therapy.

Attributes
Active Ingredient Dose Descr
Active Ingredient Dose Qty
Activity Nm
Activity Sk
Category Code Sk
Change Reason Txt
Change Type Code Sk
Comment Txt
Date Range Qty
Date Range Validation Code Sk
Delay Duration Qty
Description Txt
Distinct Product Cnt
Donor Type Code Sk
Dose Frequency Code Sk
Dose Period Code Sk
Duration Qty
Effective From Dt
Effective To Dt
End Relative To Reference Code Sk
Fasting Status Ind
Flow Rate
Identification Num
Interruption Duration Qty
Load Info Sk
Medical History Ind
Negation Ind
Negation Reason
Period Active Ingredient Dose Total Qty
Period Product Dose Total Qty
Planned Change Ind
Product Dose Descr
Product Dose Qty
Reason Code Sk
Relation Code Sk
Repeat Duration Qty
Repeat Frequency Code Sk
Repeat Frequency Ratio
Repetition Qty
Route Of Administration Code Sk
Source Code Sk
Standard Time Ind
Start Relative To Reference Code Sk
Status Change Reason Code Sk
Status Code Sk
Status Dt
Study Day Range Qty
Subcategory Code Sk
Substance Unknown Ind
Tenant Sk
Treatment Vehicle Qty
Valid From Ts
Valid To Ts

Relationship
Substance Administration Detail_Activity_FK

Primary Key
Substance Administration Detail PK

Dependencies

Reverse Dependencies

Attribute Details

Active Ingredient Dose Descr

Description	The textual representation of active ingredients in the dosing amounts or a range of dosing information used in a substance administration. For example: 200-400
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

Active Ingredient Dose Qty

Description	The quantity of active ingredients used in a substance administration. For example: 5 mg
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

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

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

Change Reason Txt

Description	The rationale for changing the substance administration in relation to the previous substance administration. For example: Dose reduced due to hematologic toxicity
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

Change Type Code Sk

Description	Specifies the modification of the substance administration in relation to the previous substance administration. For example: Agent Added Agent Dose Decreased Agent Dose Increased
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

Date Range Qty

Description	The date and time span when this activity began and ended. For example: The date and time when a sample is taken from the subject.
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

Date Range Validation Code Sk

Description	Specifies the degree of authoritativeness or certitude of the date of the activity. For example: Date estimated Date greater than 100 days - day is correct
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

Delay Duration Qty

Description	The period of time that an action is delayed relative to an original schedule. Derived from comparing the dates of the scheduled activity with the corresponding performed activity. For example: If a substance administration is delayed 2 days as a result of an adverse event, then the delay duration is 2 days.
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

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

Distinct Product Cnt

Description	The number of products (resulting from different collections) used for this substance administration. This is a count of distinct donations, typically used for stem cell transplants. For example: If blood is taken from 2 people (two donations from one of them), this would be counted as 3 different collections.
Data Type	Standards - Data Domains.ddm/Data Domains/Count [INTEGER]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Donor Type Code Sk

Description	Specifies the kind of donor that is used. For example: Syngeneic HLA-identical sibling HLA-matched other relative HLA-mismatched relative Unrelated donor
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 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

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

End Relative To Reference Code Sk

Description	Specifies when this event ended with respect to the sponsor-defined reference period. For example: Before During During/after After
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

Fasting Status Ind

Description	Specifies whether the subject had abstained from eating when the specimen was obtained.
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

Flow Rate

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

Interruption Duration Qty

Description	The period of time during which a substance administration is interrupted. For example: An infusion started at 12:15pm and ended at 2:37pm, but there was an interruption of 17 minutes.
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

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

Medical History Ind

Description	Specifies whether the activity is considered part of the historical record of a subject, that is, it did not occur within the bounds of the study.
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

Negation Ind

Description	Specifies whether an activity did not occur. For example: If a subject did not take aspirin in the previous week, the negation indicator = "true".
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

Negation Reason

Description	The text and/or code that describes why an activity did not occur. For example: Forgot to ask Sample lost
Data Type	Standards - Data Domains.ddm/Data Domains/String [VARCHAR(255)]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Period Active Ingredient Dose Total Qty

Description	The total amount of active ingredient in all doses of treatment in a given period of time.
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

Period Product Dose Total Qty

Description	The total of all doses of treatment in a given period of time. The given period of time is defined in Dose Period.
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

Planned Change Ind

Description	Specifies whether a change in the substance administration in relation to the previous substance administration is planned or not. For example: True = planned False = unplanned
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

Product Dose Descr

Description	The textual representation of dosing amounts or a range of dosing information used in a substance administration. For example: 200-400
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

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

Relation Code Sk

Description	Specifies the self-relationship of the source to the target. For example: Autologous (self) Allogeneic-related Allogeneic Unrelated
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

Repetition Qty

Description	An integer that identifies the particular occurrence of a repeating activity. The first repetition is defined as '1'. For example: A Planned Activity might have a repeat quantity of 4 which would result in 4 scheduled activities and performed activities with repetition numbers of 1, 2, 3, and 4 respectively. Derived from Scheduled ActivityRepetition Number.
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

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

Standard Time Ind

Description	Specifies whether the time of the substance administration is specified using standard (as opposed to daylight savings) time. If the location and date are known, this data is derivable.
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

Start Relative To Reference Code Sk

Description	Specifies when this event started with respect to the sponsor-defined reference period. Medications that are ongoing at the end of the reference period should have a value of "during/after". For example: Before During During/after After
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 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

Study Day Range Qty

Description	The relative timing for a performed activity expressed as the number of days offset from the study-defined reference activity (for example, date of registration, start of treatment) for this particular experimental unit. For example: Day 1 Days 10-20
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

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

Substance Unknown Ind

Description	Specifies whether the substance administered was not known.
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

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

Treatment Vehicle Qty

Description	The quantity and units of treatment vehicle used. For example: 10 milligrams 2 milliliters
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

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

Substance Administration Detail_Activity_FK

Is Identifying Relationship	true
Child Table	Substance Administration 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

Substance Administration Detail PK

Key Attribute	Activity Sk
Key Attribute	Valid From Ts

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