Atomic Warehouse Model Data Model

Entity

Entity Performed Activity Detail

Description

An activity that is successfully or unsuccessfully completed.

For example:
CBC performed on a specific Study Subject on a given day.
A scheduled blood draw that is missed by a specific Experimental Unit on a given day.

Attributes
Activity Nm
Activity Sk
Activity Type Code Sk
Category Code Sk
Comment Txt
Date Range Qty
Date Range Validation Code Sk
Delay Duration Qty
Description Txt
Duration Qty
Effective From Dt
Effective To Dt
Fasting Status Ind
Identification Num
Informed Consent Ind
Informed Consent Ts
Load Info Sk
Material Store Method Code Sk
Medical History Ind
Message Title Txt
Message Txt
Negation Ind
Negation Reason
Off Study Reason Code Sk
Off Study Ts
Original Qty
Product Transport Method Code Sk
Product Transport Standard Time Ind
Reason Code Sk
Registration Ts
Repeat Duration Qty
Repeat Frequency Code Sk
Repeat Frequency Ratio
Repetition Qty
Source Code Sk
Status Change Reason Code Sk
Status Code Sk
Status Dt
Study Day Range Qty
Study Reference From Ts
Study Reference To Ts
Subcategory Code Sk
Temperature Range Txt
Tenant Sk
Transfer Qty
Valid From Ts
Valid To Ts
Variance Reason Code Sk
Variance Type Code Sk

Relationship
Performed Activity Detail_Activity_FK

Primary Key
Performed Activity 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

Activity Type Code Sk

Description	Code identifying the actual type of the entity as per the type hierarchy defined in the business data model. For example: Performed Product Transport Administrative Activity Performed Notification Performed Study Agent Transfer Study Subject Milestone
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

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

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

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

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

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

Informed Consent Ind

Description	Specifies whether the study subject gave official consent by signing the official consent form.
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

Informed Consent Ts

Description	The date (and time) the study subject gives official consent by signing the official consent form.
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

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

Material Store Method Code Sk

Description	Specifies the technique that is used to store the material. For example: Liquid nitrogen Vapor phase Electric freezer
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

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

Message Title Txt

Description	The subject of the notification.
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

Message Txt

Description	The actual text that was included in the notification.
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

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

Off Study Reason Code Sk

Description	Specifies why the subject is removed from a study. For example: Patient died
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

Off Study Ts

Description	The date (and time) when the study subject is removed from the study. For example: The subject is not being followed and will not be retreated.
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

Original Qty

Description	The amount and unit of study agent transferred in original units. Original units can be derived from the translation attribute of the PQ data type Performed Study Agent Transfer Quantity.
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 Transport Method Code Sk

Description	Specifies the technique that is used to transport the product. For example: Frozen gel pack Room temperature per transplant center 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

Product Transport Standard Time Ind

Description	Specifies whether the time of the product transport 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

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

Registration Ts

Description	The date (and time) the subject has been registered to the study assuming they have finished screening and have been found eligible.
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

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

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

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

Study Reference From Ts

Description	The date (and time) used to indicate the start of the study for a subject.
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 Reference To Ts

Description	The date (and time) used to indicate the end of the study for a subject.
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

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

Temperature Range Txt

Description	The thermal reading at which the storage unit was set. For example: gt -80 degrees celsius -135 to -80 degrees celsius
Data Type	Standards - Data Domains.ddm/Data Domains/Text Small [VARCHAR(50)]
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

Transfer Qty

Description	The amount and unit of study agent transferred in standard or canonical units.
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

Variance Reason Code Sk

Description	Describes why what occurred is different from what was expected. For example: Subject received early treatment because of vacation plans.
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

Variance Type Code Sk

Description	Specifies the kind of variance. For example: Early / late occurrence of an act Higher / lower amount transferred
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

Relationship Details

Performed Activity Detail_Activity_FK

Is Identifying Relationship	true
Child Table	Performed Activity 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

Performed Activity Detail PK

Key Attribute	Activity Sk
Key Attribute	Valid From Ts

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Atomic Warehouse Model Data Model