Entity Activity Fact

DescriptionAn action that can, in the context of a study or a post-marketing investigation, be defined, planned, scheduled or performed.

For example:
Administrative activities such as subject registration or informed consent.
Clinical activities such as surgical procedure, laboratory test, administration of a drug.

Attributes
Activity Fact BkActivity Fact Bk
Activity Fact DkActivity Fact Dk
Activity Fact SkActivity Fact Sk
Activity NmActivity Nm
Actual Active Ingredient Dose DescrActual Active Ingredient Dose Descr
Actual Active Ingredient Dose QtyActual Active Ingredient Dose Qty
Actual Copy of Dose Frequency CdActual Copy of Dose Frequency Cd
Actual Copy of Dose Frequency Code SkActual Copy of Dose Frequency Code Sk
Actual Dose Period CdActual Dose Period Cd
Actual Dose Period Code SkActual Dose Period Code Sk
Actual Flow RtActual Flow Rt
Actual Period Active Ingredient Dose Total QtyActual Period Active Ingredient Dose Total Qty
Actual Period Product Dose Total QtyActual Period Product Dose Total Qty
Actual Product Dose DescrActual Product Dose Descr
Actual Product Dose QtyActual Product Dose Qty
Actual Route Of Administration CdActual Route Of Administration Cd
Actual Route Of Administration Code SkActual Route Of Administration Code Sk
Agent Administration Care Setting Type CdAgent Administration Care Setting Type Cd
Agent Administration Care Setting Type Code SkAgent Administration Care Setting Type Code Sk
Approach Anatomic Site CdApproach Anatomic Site Cd
Approach Anatomic Site Code SkApproach Anatomic Site Code Sk
Approach Anatomic Site Laterality CdApproach Anatomic Site Laterality Cd
Approach Anatomic Site Laterality Code SkApproach Anatomic Site Laterality Code Sk
AWM Load Info SkAWM Load Info Sk
Blinded DescrBlinded Descr
Calendar DkCalendar Dk
Category CdCategory Cd
Category Code SkCategory Code Sk
Change Reason TxtChange Reason Txt
Change Type CdChange Type Cd
Change Type Code SkChange Type Code Sk
Comment TxtComment Txt
Current IndCurrent Ind
Date Range QtyDate Range Qty
Date Range Validation CdDate Range Validation Cd
Date Range Validation Code SkDate Range Validation Code Sk
Defined Dose Frequency CdDefined Dose Frequency Cd
Defined Dose Frequency Code SkDefined Dose Frequency Code Sk
Defined Dose Period CdDefined Dose Period Cd
Defined Dose Period Code SkDefined Dose Period Code Sk
Defined Dose Regimen TxtDefined Dose Regimen Txt
Defined Flow RtDefined Flow Rt
Defined Notification Message Title TxtDefined Notification Message Title Txt
Defined Notification Message TxtDefined Notification Message Txt
Defined Period Product Dose Total QtyDefined Period Product Dose Total Qty
Defined Product Dose QtyDefined Product Dose Qty
Defined Route Of Administration CdDefined Route Of Administration Cd
Defined Route Of Administration Code SkDefined Route Of Administration Code Sk
Delay Duration QtyDelay Duration Qty
Delivery Mechanism CdDelivery Mechanism Cd
Delivery Mechanism Code SkDelivery Mechanism Code Sk
Description TxtDescription Txt
Distinct Product CntDistinct Product Cnt
Document DkDocument Dk
Document SkDocument Sk
Donor Type CdDonor Type Cd
Donor Type Code SkDonor Type Code Sk
Duration QtyDuration Qty
DWM Load Info SkDWM Load Info Sk
Effective From DtEffective From Dt
Effective To DtEffective To Dt
End Relative To Reference CdEnd Relative To Reference Cd
End Relative To Reference Code SkEnd Relative To Reference Code Sk
Epoch DkEpoch Dk
Epoch SkEpoch Sk
Experimental Unit DkExperimental Unit Dk
Experimental Unit SkExperimental Unit Sk
Fasting Status IndFasting Status Ind
Identification NumIdentification Num
Informed Consent IndInformed Consent Ind
Informed Consent TsInformed Consent Ts
Interruptible IndInterruptible Ind
Interruption Duration QtyInterruption Duration Qty
Material Store Method CdMaterial Store Method Cd
Material Store Method Code SkMaterial Store Method Code Sk
Medical History IndMedical History Ind
Method CdMethod Cd
Method Code SkMethod Code Sk
Name Code Modified TxtName Code Modified Txt
Negation IndNegation Ind
Negation ReasonNegation Reason
Notified Organization DkNotified Organization Dk
Notified Organization SkNotified Organization Sk
Notified Person DkNotified Person Dk
Notified Person SkNotified Person Sk
Notified Practitioner DkNotified Practitioner Dk
Notified Practitioner SkNotified Practitioner Sk
Off Study Reason CdOff Study Reason Cd
Off Study Reason Code SkOff Study Reason Code Sk
Off Study TsOff Study Ts
Original QtyOriginal Qty
Performed Notification Message Title TxtPerformed Notification Message Title Txt
Performed Notification Message TxtPerformed Notification Message Txt
Performing Organization DkPerforming Organization Dk
Performing Organization SkPerforming Organization Sk
Performing Person DkPerforming Person Dk
Performing Person SkPerforming Person Sk
Planned Change IndPlanned Change Ind
Planned Repeat Frequency CdPlanned Repeat Frequency Cd
Planned Repeat Frequency Code SkPlanned Repeat Frequency Code Sk
Planned Repeat Frequency RatioPlanned Repeat Frequency Ratio
Planned Study Day Range QtyPlanned Study Day Range Qty
Point Of Care Location DkPoint Of Care Location Dk
Point Of Care Location SkPoint Of Care Location Sk
Product DkProduct Dk
Product SkProduct Sk
Product Transport Method CdProduct Transport Method Cd
Product Transport Method Code SkProduct Transport Method Code Sk
Product Transport Standard Time IndProduct Transport Standard Time Ind
Protocol Arm DkProtocol Arm Dk
Protocol Arm SkProtocol Arm Sk
Purpose TxtPurpose Txt
Reason CdReason Cd
Reason Code SkReason Code Sk
Registration TsRegistration Ts
Relation CdRelation Cd
Relation Code SkRelation Code Sk
Repeat Duration QtyRepeat Duration Qty
Repeat Frequency CdRepeat Frequency Cd
Repeat Frequency Code SkRepeat Frequency Code Sk
Repeat Frequency RatioRepeat Frequency Ratio
Repeat Quantity RangeRepeat Quantity Range
Repetition QtyRepetition Qty
Scheduled Active Ingredient Dose QtyScheduled Active Ingredient Dose Qty
Scheduled End DtScheduled End Dt
Scheduled Notification Message Title TxtScheduled Notification Message Title Txt
Scheduled Notification Message TxtScheduled Notification Message Txt
Scheduled Repetition NumScheduled Repetition Num
Scheduled Start DtScheduled Start Dt
Source CdSource Cd
Source Code SkSource Code Sk
Specimen DkSpecimen Dk
Specimen SkSpecimen Sk
Standard Time IndStandard Time Ind
Start Relative To Reference CdStart Relative To Reference Cd
Start Relative To Reference Code SkStart Relative To Reference Code Sk
Status CdStatus Cd
Status Change Reason CdStatus Change Reason Cd
Status Change Reason Code SkStatus Change Reason Code Sk
Status Code SkStatus Code Sk
Status DtStatus Dt
Study Accrual Threshold PctStudy Accrual Threshold Pct
Study Day Range QtyStudy Day Range Qty
Study DkStudy Dk
Study Focus IndStudy Focus Ind
Study Protocol DkStudy Protocol Dk
Study Protocol SkStudy Protocol Sk
Study Reference From TsStudy Reference From Ts
Study Reference To TsStudy Reference To Ts
Study Site Accrual Threshold PctStudy Site Accrual Threshold Pct
Study Site DkStudy Site Dk
Study Site SkStudy Site Sk
Study SkStudy Sk
Study Subject DkStudy Subject Dk
Study Subject SkStudy Subject Sk
Subcategory CdSubcategory Cd
Subcategory Code SkSubcategory Code Sk
Substance Unknown IndSubstance Unknown Ind
Target Anatomic Site CdTarget Anatomic Site Cd
Target Anatomic Site Code SkTarget Anatomic Site Code Sk
Target Anatomic Site Laterality CdTarget Anatomic Site Laterality Cd
Target Anatomic Site Laterality Code SkTarget Anatomic Site Laterality Code Sk
Temperature Range TxtTemperature Range Txt
Tenant SkTenant Sk
Transfer QtyTransfer Qty
Treatment Vehicle QtyTreatment Vehicle Qty
Valid From TsValid From Ts
Valid To TsValid To Ts
Variance Reason CdVariance Reason Cd
Variance Reason Code SkVariance Reason Code Sk
Variance Type CdVariance Type Cd
Variance Type Code SkVariance Type Code Sk

Relationship
Activity Fact_Product Dimension_FKActivity Fact_Product Dimension_FK
Activity Fact_Experimental Unit Dimension_FKActivity Fact_Experimental Unit Dimension_FK
Activity Fact_Organization Dimension_FKActivity Fact_Organization Dimension_FK
Activity Fact_Practitioner Dimension_FKActivity Fact_Practitioner Dimension_FK
Activity Fact_Point Of Care Location Dimension_FKActivity Fact_Point Of Care Location Dimension_FK
Activity Fact_Document Dimension_FKActivity Fact_Document Dimension_FK
Activity Fact_Person Dimension_FKActivity Fact_Person Dimension_FK
Activity Fact_Person Dimension_FK1Activity Fact_Person Dimension_FK1
Activity Fact_Organization Dimension_FK1Activity Fact_Organization Dimension_FK1
Activity Fact_Calendar Dimension_FKActivity Fact_Calendar Dimension_FK
Activity Fact_Study Protocol Dimension_FKActivity Fact_Study Protocol Dimension_FK
Activity Fact_Protocol Arm Dimension_FKActivity Fact_Protocol Arm Dimension_FK
Activity Fact_Epoch_FKActivity Fact_Epoch_FK
Activity Fact_Study Dimension_FKActivity Fact_Study Dimension_FK
Activity Fact_Study Subject Dimension_FKActivity Fact_Study Subject Dimension_FK
Activity Fact_Specimen Dimension_FKActivity Fact_Specimen Dimension_FK
Activity Fact_Study Site Dimension_FKActivity Fact_Study Site Dimension_FK

Primary Key
Activity Fact PKActivity Fact PK

Dependencies
 
 
 
 
 
 
 

Reverse Dependencies
 

Attribute Details

 Activity Fact Bk
DescriptionConcatenated values of a set of business attributes that uniquely identify the row.
Data TypeStandards - Data Domains.ddm/Data Domains/Business Key [VARCHAR(255)]
Is Part Of PrimaryKeyfalse
Is Requiredtrue
Is Derivedfalse
Is Surrogate Keyfalse



 Activity Fact Dk
DescriptionA numeric surrogate key used to uniquely identify entities in the dimensional model.
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key Large [LONG]
Is Part Of PrimaryKeytrue
Is Requiredtrue
Is Derivedfalse
Is Surrogate Keytrue



 Activity Fact Sk
DescriptionA numeric surrogate key used to uniquely identify entities in the atomic model.
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key Large [LONG]
Is Part Of PrimaryKeyfalse
Is Requiredtrue
Is Derivedfalse
Is Surrogate Keyfalse



 Activity Nm
DescriptionThe text description of an activity within a clinical trial or study.
Data TypeStandards - Data Domains.ddm/Data Domains/Text Large [VARCHAR(1024)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Actual Active Ingredient Dose Descr
DescriptionThe 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 TypeStandards - Data Domains.ddm/Data Domains/Text Large [VARCHAR(1024)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Actual Active Ingredient Dose Qty
DescriptionThe quantity of active ingredients used in a substance administration.

For example:
5 mg
Data TypeStandards - Data Domains.ddm/Data Domains/Quantity Integer [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Actual Copy of Dose Frequency Cd
DescriptionSpecifies 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 TypeStandards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Actual Copy of Dose Frequency Code Sk
DescriptionSpecifies 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 TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Actual Dose Period Cd
DescriptionSpecifies the period during which the dose total is administered.

For example:
Daily
Course
Data TypeStandards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Actual Dose Period Code Sk
DescriptionSpecifies the period during which the dose total is administered.

For example:
Daily
Course
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Actual Flow Rt
DescriptionA 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 TypeStandards - Data Domains.ddm/Data Domains/Rate [FLOAT(5)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Actual Period Active Ingredient Dose Total Qty
DescriptionThe total amount of active ingredient in all doses of treatment in a given period of time.
Data TypeStandards - Data Domains.ddm/Data Domains/Quantity Integer [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Actual Period Product Dose Total Qty
DescriptionThe total of all doses of treatment in a given period of time. The given period of time is defined in Dose Period.
Data TypeStandards - Data Domains.ddm/Data Domains/Quantity Integer [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Actual Product Dose Descr
DescriptionThe textual representation of dosing amounts or a range of dosing information used in a substance administration.

For example:
200-400
Data TypeStandards - Data Domains.ddm/Data Domains/Text Large [VARCHAR(1024)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Actual Product Dose Qty
DescriptionThe quantity of a substance or medication to be administered.

For example:
5 mg
20 mg of drug per kg of subject weight
Data TypeStandards - Data Domains.ddm/Data Domains/Quantity Integer [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Actual Route Of Administration Cd
DescriptionIdentifies the route of administration.

For example:
Apply Externally
Buccal
Dental
Intravenous
Oral
Intra-arterial
Data TypeStandards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Actual Route Of Administration Code Sk
DescriptionIdentifies the route of administration.

For example:
Apply Externally
Buccal
Dental
Intravenous
Oral
Intra-arterial
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Agent Administration Care Setting Type Cd
DescriptionIdentifies the level of healthcare (care setting) required by the subject based on the nature of the procedure.

For example:
Some, but not all, agents given as inpatient
All agents given as inpatient
All agents given as outpatient
Data TypeStandards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Agent Administration Care Setting Type Code Sk
DescriptionIdentifies the level of healthcare (care setting) required by the subject based on the nature of the procedure.

For example:
Some, but not all, agents given as inpatient
All agents given as inpatient
All agents given as outpatient
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Approach Anatomic Site Cd
DescriptionIdentifies 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 TypeStandards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Approach Anatomic Site Code Sk
DescriptionIdentifies 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 TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Approach Anatomic Site Laterality Cd
DescriptionSpecifies 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 TypeStandards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Approach Anatomic Site Laterality Code Sk
DescriptionSpecifies 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 TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 AWM Load Info Sk
DescriptionThe surrogate key of the load information entry describing the details regarding the loading of the row in the atomic data warehouse.
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key Large [LONG]
Is Part Of PrimaryKeyfalse
Is Requiredtrue
Is Derivedfalse
Is Surrogate Keyfalse



 Blinded Descr
DescriptionThe textual representation of the planned activity from the point of view of a blinded participant (study subject or study investigator).

For example:
During the second treatment epoch of a study, Arms A and B are still blinded and Arm C is no longer blinded. So, Arm A and B must have identical blinded descriptions.

In a study with 3 arms, Arm 1: standard vaccine given in three shots at 2 months, 5 months, and 12 months of age; Arm 2: new vaccine given in three shots at 2 months, 5 months, and 12 months of age; Arm 3: new vaccine given in two shots at 2 months and 5 months of age. Subjects assigned to the third arm are unblinded at some point during 5 months and 12 months. By the time of the Third Shot Epoch, the "Arm 3/Third Shot" activity can be called by this, its unblinded name. However, the "Arm 1/Third Shot" and "Arm2/Third Shot" activities still need blinded names. Both these activities would have the blinded name (something like) "3-shot Arm/Third Shot".
Data TypeStandards - Data Domains.ddm/Data Domains/Text Large [VARCHAR(1024)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Calendar Dk
DescriptionA numeric surrogate key used to uniquely identify entities in the dimensional model.
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key Large [LONG]
Is Part Of PrimaryKeyfalse
Is Requiredtrue
Is Derivedfalse
Is Surrogate Keyfalse



 Category Cd
DescriptionClassification 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 TypeStandards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Category Code Sk
DescriptionClassification 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 TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Change Reason Txt
DescriptionThe rationale for changing the substance administration in relation to the previous substance administration.

For example:
Dose reduced due to hematologic toxicity
Data TypeStandards - Data Domains.ddm/Data Domains/Text Large [VARCHAR(1024)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Change Type Cd
DescriptionSpecifies the modification of the substance administration in relation to the previous substance administration.

For example:
Agent Added
Agent Dose Decreased
Agent Dose Increased
Data TypeStandards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Change Type Code Sk
DescriptionSpecifies the modification of the substance administration in relation to the previous substance administration.

For example:
Agent Added
Agent Dose Decreased
Agent Dose Increased
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Comment Txt
DescriptionAdditional description of the activity.

For example:
Guidance on how to perform the observation.
Data TypeStandards - Data Domains.ddm/Data Domains/Text Large [VARCHAR(1024)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Current Ind
DescriptionSet to 'Y' if this is the most recent row of a group having the same Surrogate Key.
Data TypeStandards - Data Domains.ddm/Data Domains/Boolean Indicator [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredtrue
Is Derivedfalse
Is Surrogate Keyfalse



 Date Range Qty
DescriptionThe 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 TypeStandards - Data Domains.ddm/Data Domains/Quantity Integer [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Date Range Validation Cd
DescriptionSpecifies 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 TypeStandards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Date Range Validation Code Sk
DescriptionSpecifies 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 TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Defined Dose Frequency Cd
DescriptionSpecifies 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 TypeStandards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Defined Dose Frequency Code Sk
DescriptionSpecifies 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 TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Defined Dose Period Cd
DescriptionSpecifies the period during which the dose total is administered.

For example:
Daily
Course
Data TypeStandards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Defined Dose Period Code Sk
DescriptionSpecifies the period during which the dose total is administered.

For example:
Daily
Course
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Defined Dose Regimen Txt
DescriptionText 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 TypeStandards - Data Domains.ddm/Data Domains/Text Large [VARCHAR(1024)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Defined Flow Rt
DescriptionA 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 TypeStandards - Data Domains.ddm/Data Domains/Rate [FLOAT(5)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Defined Notification Message Title Txt
DescriptionThe subject of the notification.
Data TypeStandards - Data Domains.ddm/Data Domains/Text Large [VARCHAR(1024)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Defined Notification Message Txt
DescriptionThe text that is to be included in the notification. The message text may contain substitution tags that when used in the context of a particular study are replaced with study name or study site and so on.
Data TypeStandards - Data Domains.ddm/Data Domains/Text Large [VARCHAR(1024)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Defined Period Product Dose Total Qty
DescriptionTotal 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 TypeStandards - Data Domains.ddm/Data Domains/Quantity Integer [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Defined Product Dose Qty
DescriptionThe quantity of a substance or medication to be administered.

For example:
5 mg
20 mg of drug per kg of subject weight
Data TypeStandards - Data Domains.ddm/Data Domains/Quantity Integer [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Defined Route Of Administration Cd
DescriptionIdentifies the route of administration.

For example:
Apply Externally
Buccal
Dental
Intravenous
Oral
Intra-arterial
Data TypeStandards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Defined Route Of Administration Code Sk
DescriptionIdentifies the route of administration.

For example:
Apply Externally
Buccal
Dental
Intravenous
Oral
Intra-arterial
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Delay Duration Qty
DescriptionThe 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 TypeStandards - Data Domains.ddm/Data Domains/Quantity Integer [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Delivery Mechanism Cd
DescriptionSpecifies how the notification message is to be delivered.

For example:
email
Data TypeStandards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Delivery Mechanism Code Sk
DescriptionSpecifies how the notification message is to be delivered.

For example:
email
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Description Txt
DescriptionThe textual representation of the activity.
Data TypeStandards - Data Domains.ddm/Data Domains/Text Large [VARCHAR(1024)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Distinct Product Cnt
DescriptionThe 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 TypeStandards - Data Domains.ddm/Data Domains/Count [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Document Dk
DescriptionA numeric surrogate key used to uniquely identify entities in the dimensional model.
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key Large [LONG]
Is Part Of PrimaryKeyfalse
Is Requiredtrue
Is Derivedfalse
Is Surrogate Keyfalse



 Document Sk
DescriptionA numeric surrogate key used to uniquely identify entities in the atomic model.
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key Large [LONG]
Is Part Of PrimaryKeyfalse
Is Requiredtrue
Is Derivedfalse
Is Surrogate Keyfalse



 Donor Type Cd
DescriptionSpecifies the kind of donor that is used.

For example:
Syngeneic
HLA-identical sibling
HLA-matched other relative
HLA-mismatched relative
Unrelated donor
Data TypeStandards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Donor Type Code Sk
DescriptionSpecifies the kind of donor that is used.

For example:
Syngeneic
HLA-identical sibling
HLA-matched other relative
HLA-mismatched relative
Unrelated donor
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Duration Qty
DescriptionThe 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 TypeStandards - Data Domains.ddm/Data Domains/Quantity Integer [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 DWM Load Info Sk
DescriptionThe surrogate key of the load information entry describing the details regarding the loading of the row.
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key Large [LONG]
Is Part Of PrimaryKeyfalse
Is Requiredtrue
Is Derivedfalse
Is Surrogate Keyfalse



 Effective From Dt
DescriptionEstablishes a period where a set of attributes are true according to the business.
Data TypeStandards - Data Domains.ddm/Data Domains/Date [DATE]
Is Part Of PrimaryKeyfalse
Is Requiredtrue
Is Derivedfalse
Is Surrogate Keyfalse



 Effective To Dt
DescriptionEnds a period of effectivity.
Data TypeStandards - Data Domains.ddm/Data Domains/Date [DATE]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 End Relative To Reference Cd
DescriptionSpecifies when this event ended with respect to the sponsor-defined reference period.

For example:
Before
During
During/after
After
Data TypeStandards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 End Relative To Reference Code Sk
DescriptionSpecifies when this event ended with respect to the sponsor-defined reference period.

For example:
Before
During
During/after
After
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Epoch Dk
DescriptionA numeric surrogate key used to uniquely identify entities in the dimensional model.
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key Large [LONG]
Is Part Of PrimaryKeyfalse
Is Requiredtrue
Is Derivedfalse
Is Surrogate Keyfalse



 Epoch Sk
DescriptionA numeric surrogate key used to uniquely identify entities in the atomic model.
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key Large [LONG]
Is Part Of PrimaryKeyfalse
Is Requiredtrue
Is Derivedfalse
Is Surrogate Keyfalse



 Experimental Unit Dk
DescriptionA numeric surrogate key used to uniquely identify entities in the dimensional model.
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key Large [LONG]
Is Part Of PrimaryKeyfalse
Is Requiredtrue
Is Derivedfalse
Is Surrogate Keyfalse



 Experimental Unit Sk
DescriptionA numeric surrogate key used to uniquely identify entities in the atomic model.
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key Large [LONG]
Is Part Of PrimaryKeyfalse
Is Requiredtrue
Is Derivedfalse
Is Surrogate Keyfalse



 Fasting Status Ind
DescriptionSpecifies whether the subject had abstained from eating when the specimen was obtained.
Data TypeStandards - Data Domains.ddm/Data Domains/Boolean Indicator [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Identification Num
DescriptionA unique symbol that establishes identity of an activity.

For example:
12345 is the identifier for a substance administration
Data TypeStandards - Data Domains.ddm/Data Domains/Alphanumeric [VARCHAR(80)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Informed Consent Ind
DescriptionSpecifies whether the study subject gave official consent by signing the official consent form.
Data TypeStandards - Data Domains.ddm/Data Domains/Boolean Indicator [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Informed Consent Ts
DescriptionThe date (and time) the study subject gives official consent by signing the official consent form.
Data TypeStandards - Data Domains.ddm/Data Domains/Date Time [TIMESTAMP]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Interruptible Ind
DescriptionSpecifies whether the planned activity is interruptible by asynchronous events. This may only be useful for Planned Subject Activity Groups or administrative activities.
Data TypeStandards - Data Domains.ddm/Data Domains/Boolean Indicator [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Interruption Duration Qty
DescriptionThe 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 TypeStandards - Data Domains.ddm/Data Domains/Quantity Integer [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Material Store Method Cd
DescriptionSpecifies the technique that is used to store the material.

For example:
Liquid nitrogen
Vapor phase
Electric freezer
Data TypeStandards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Material Store Method Code Sk
DescriptionSpecifies the technique that is used to store the material.

For example:
Liquid nitrogen
Vapor phase
Electric freezer
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Medical History Ind
DescriptionSpecifies 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 TypeStandards - Data Domains.ddm/Data Domains/Boolean Indicator [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Method Cd
DescriptionIdentifies 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 TypeStandards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Method Code Sk
DescriptionIdentifies 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 TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Name Code Modified Txt
DescriptionA 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 TypeStandards - Data Domains.ddm/Data Domains/Text Large [VARCHAR(1024)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Negation Ind
DescriptionSpecifies whether an activity did not occur.

For example:
If a subject did not take aspirin in the previous week, the negation indicator = "true".
Data TypeStandards - Data Domains.ddm/Data Domains/Boolean Indicator [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Negation Reason
DescriptionThe text and/or code that describes why an activity did not occur.

For example:
Forgot to ask
Sample lost
Data TypeStandards - Data Domains.ddm/Data Domains/String [VARCHAR(255)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Notified Organization Dk
DescriptionA numeric surrogate key used to uniquely identify entities in the dimensional model.
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key Large [LONG]
Is Part Of PrimaryKeyfalse
Is Requiredtrue
Is Derivedfalse
Is Surrogate Keyfalse



 Notified Organization Sk
DescriptionA numeric surrogate key used to uniquely identify entities in the atomic model.
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key Large [LONG]
Is Part Of PrimaryKeyfalse
Is Requiredtrue
Is Derivedfalse
Is Surrogate Keyfalse



 Notified Person Dk
DescriptionA numeric surrogate key used to uniquely identify entities in the dimensional model.
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key Large [LONG]
Is Part Of PrimaryKeyfalse
Is Requiredtrue
Is Derivedfalse
Is Surrogate Keyfalse



 Notified Person Sk
DescriptionA numeric surrogate key used to uniquely identify entities in the atomic model.
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key Large [LONG]
Is Part Of PrimaryKeyfalse
Is Requiredtrue
Is Derivedfalse
Is Surrogate Keyfalse



 Notified Practitioner Dk
DescriptionA numeric surrogate key used to uniquely identify entities in the dimensional model.
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key Large [LONG]
Is Part Of PrimaryKeyfalse
Is Requiredtrue
Is Derivedfalse
Is Surrogate Keyfalse



 Notified Practitioner Sk
DescriptionA numeric surrogate key used to uniquely identify entities in the atomic model.
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key Large [LONG]
Is Part Of PrimaryKeyfalse
Is Requiredtrue
Is Derivedfalse
Is Surrogate Keyfalse



 Off Study Reason Cd
DescriptionSpecifies why the subject is removed from a study.

For example:
Patient died
Data TypeStandards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Off Study Reason Code Sk
DescriptionSpecifies why the subject is removed from a study.

For example:
Patient died
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Off Study Ts
DescriptionThe 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 TypeStandards - Data Domains.ddm/Data Domains/Date Time [TIMESTAMP]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Original Qty
DescriptionThe 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 TypeStandards - Data Domains.ddm/Data Domains/Quantity Integer [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Performed Notification Message Title Txt
DescriptionThe subject of the notification.
Data TypeStandards - Data Domains.ddm/Data Domains/Text Large [VARCHAR(1024)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Performed Notification Message Txt
DescriptionThe actual text that was included in the notification.
Data TypeStandards - Data Domains.ddm/Data Domains/Text Large [VARCHAR(1024)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Performing Organization Dk
DescriptionA numeric surrogate key used to uniquely identify entities in the dimensional model.
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key Large [LONG]
Is Part Of PrimaryKeyfalse
Is Requiredtrue
Is Derivedfalse
Is Surrogate Keyfalse



 Performing Organization Sk
DescriptionA numeric surrogate key used to uniquely identify entities in the atomic model.
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key Large [LONG]
Is Part Of PrimaryKeyfalse
Is Requiredtrue
Is Derivedfalse
Is Surrogate Keyfalse



 Performing Person Dk
DescriptionA numeric surrogate key used to uniquely identify entities in the dimensional model.
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key Large [LONG]
Is Part Of PrimaryKeyfalse
Is Requiredtrue
Is Derivedfalse
Is Surrogate Keyfalse



 Performing Person Sk
DescriptionA numeric surrogate key used to uniquely identify entities in the atomic model.
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key Large [LONG]
Is Part Of PrimaryKeyfalse
Is Requiredtrue
Is Derivedfalse
Is Surrogate Keyfalse



 Planned Change Ind
DescriptionSpecifies 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 TypeStandards - Data Domains.ddm/Data Domains/Boolean Indicator [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Planned Repeat Frequency Cd
DescriptionThe 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 TypeStandards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Planned Repeat Frequency Code Sk
DescriptionThe 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 TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Planned Repeat Frequency Ratio
DescriptionA ratio representing the number of occurrences of a planned activity within a given time period.

For example:
Once per 12 hours
2 times per day
Data TypeStandards - Data Domains.ddm/Data Domains/Ratio [FLOAT(5)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Planned Study Day Range Qty
DescriptionThe relative timing for a planned activity expressed as the number of days offset from the study-defined reference activity (for example, date of registration, start of treatment) for a particular subject, study subject or experimental unit.

For example:
Day 1
Days 10-20
Data TypeStandards - Data Domains.ddm/Data Domains/Quantity Integer [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Point Of Care Location Dk
DescriptionA numeric surrogate key used to uniquely identify entities in the dimensional model.
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key Large [LONG]
Is Part Of PrimaryKeyfalse
Is Requiredtrue
Is Derivedfalse
Is Surrogate Keyfalse



 Point Of Care Location Sk
DescriptionA numeric surrogate key used to uniquely identify entities in the atomic model.
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key Large [LONG]
Is Part Of PrimaryKeyfalse
Is Requiredtrue
Is Derivedfalse
Is Surrogate Keyfalse



 Product Dk
DescriptionA numeric surrogate key used to uniquely identify entities in the dimensional model.
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredtrue
Is Derivedfalse
Is Surrogate Keyfalse



 Product Sk
DescriptionA numeric surrogate key used to uniquely identify entities in the atomic model.
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key Large [LONG]
Is Part Of PrimaryKeyfalse
Is Requiredtrue
Is Derivedfalse
Is Surrogate Keyfalse



 Product Transport Method Cd
DescriptionSpecifies the technique that is used to transport the product.

For example:
Frozen gel pack
Room temperature per transplant center request
Data TypeStandards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Product Transport Method Code Sk
DescriptionSpecifies the technique that is used to transport the product.

For example:
Frozen gel pack
Room temperature per transplant center request
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Product Transport Standard Time Ind
DescriptionSpecifies 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 TypeStandards - Data Domains.ddm/Data Domains/Boolean Indicator [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Protocol Arm Dk
DescriptionA numeric surrogate key used to uniquely identify entities in the dimensional model.
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key Large [LONG]
Is Part Of PrimaryKeyfalse
Is Requiredtrue
Is Derivedfalse
Is Surrogate Keyfalse



 Protocol Arm Sk
DescriptionA numeric surrogate key used to uniquely identify entities in the atomic model.
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key Large [LONG]
Is Part Of PrimaryKeyfalse
Is Requiredtrue
Is Derivedfalse
Is Surrogate Keyfalse



 Purpose Txt
DescriptionThe reason for the planned activity.

For example:
Treating a disease (treatment)
Determining eligibility for a study (screening)

Per GForge Tracker item 31402, this attribute is redundant and we're deprecating it in favor of the existing Activity Reason Code.
Data TypeStandards - Data Domains.ddm/Data Domains/Text Large [VARCHAR(1024)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Reason Cd
DescriptionA 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 TypeStandards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Reason Code Sk
DescriptionA 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 TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Registration Ts
DescriptionThe date (and time) the subject has been registered to the study assuming they have finished screening and have been found eligible.
Data TypeStandards - Data Domains.ddm/Data Domains/Date Time [TIMESTAMP]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Relation Cd
DescriptionSpecifies the self-relationship of the source to the target.

For example:
Autologous (self)
Allogeneic-related
Allogeneic Unrelated
Data TypeStandards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Relation Code Sk
DescriptionSpecifies the self-relationship of the source to the target.

For example:
Autologous (self)
Allogeneic-related
Allogeneic Unrelated
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Repeat Duration Qty
DescriptionThe period of time over which the activity is repeated.
Data TypeStandards - Data Domains.ddm/Data Domains/Quantity Integer [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Repeat Frequency Cd
DescriptionThe 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 TypeStandards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Repeat Frequency Code Sk
DescriptionThe 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 TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Repeat Frequency Ratio
DescriptionA 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 TypeStandards - Data Domains.ddm/Data Domains/Ratio [FLOAT(5)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Repeat Quantity Range
DescriptionAn integer falling within minimum and maximum bounds that specifies how many times the planned activity occurs. If the frequency is more than once a day, this is still interpreted per time, for example, BID for 5 days is 10 repeats.
Data TypeStandards - Data Domains.ddm/Data Domains/Quantity Integer [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Repetition Qty
DescriptionAn 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 TypeStandards - Data Domains.ddm/Data Domains/Quantity Integer [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Scheduled Active Ingredient Dose Qty
DescriptionThe quantity of active ingredient anticipated to be administered.

For Example:
5 mg
This is intended to be a subject-specific quantity.

Defined Substance Administration Product Dose can contain a dose expressed in absolute or relative terms (for example, mg or mg/kg). Scheduled Substance Administration Active Ingredient Dose and Performed Substance Administration Product Dose must contain a dose expressed in absolute terms (for example, mg). If the Defined Substance Administration Product Dose was expressed in relative terms (for example, mg/kg), then the absolute dose must have been calculated using one or more observed factors as identified by the Defined Dose Expression Variable Relationship.
Data TypeStandards - Data Domains.ddm/Data Domains/Quantity Integer [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Scheduled End Dt
DescriptionThe expected end date of the scheduled activity.
Data TypeStandards - Data Domains.ddm/Data Domains/Date [DATE]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Scheduled Notification Message Title Txt
DescriptionThe subject of the notification.
Data TypeStandards - Data Domains.ddm/Data Domains/Text Large [VARCHAR(1024)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Scheduled Notification Message Txt
DescriptionThe actual text scheduled to be included in the notification. This may mean that message variables have been replaced with actual data.
Data TypeStandards - Data Domains.ddm/Data Domains/Text Large [VARCHAR(1024)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Scheduled Repetition Num
DescriptionAn 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 with repetition numbers of 1, 2, 3, and 4 respectively.
Data TypeStandards - Data Domains.ddm/Data Domains/Quantity Integer [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Scheduled Start Dt
DescriptionThe expected start date of the scheduled activity.
Data TypeStandards - Data Domains.ddm/Data Domains/Date [DATE]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Source Cd
DescriptionThe code that corresponds to the Source Code Sk.
Data TypeStandards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)]
Is Part Of PrimaryKeyfalse
Is Requiredtrue
Is Derivedfalse
Is Surrogate Keyfalse



 Source Code Sk
DescriptionThe 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 TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredtrue
Is Derivedfalse
Is Surrogate Keyfalse



 Specimen Dk
DescriptionA numeric surrogate key used to uniquely identify entities in the dimensional model.
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key Large [LONG]
Is Part Of PrimaryKeyfalse
Is Requiredtrue
Is Derivedfalse
Is Surrogate Keyfalse



 Specimen Sk
DescriptionA numeric surrogate key used to uniquely identify entities in the atomic model.
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key Large [LONG]
Is Part Of PrimaryKeyfalse
Is Requiredtrue
Is Derivedfalse
Is Surrogate Keyfalse



 Standard Time Ind
DescriptionSpecifies 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 TypeStandards - Data Domains.ddm/Data Domains/Boolean Indicator [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Start Relative To Reference Cd
DescriptionSpecifies 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 TypeStandards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Start Relative To Reference Code Sk
DescriptionSpecifies 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 TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Status Cd
DescriptionIndicates the phase in the lifecycle of the activity as part of a global library.

For example:
Draft New
Released
Retired
Archived
Data TypeStandards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Status Change Reason Cd
DescriptionSpecifies why the status has changed.
Data TypeStandards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Status Change Reason Code Sk
DescriptionSpecifies why the status has changed.
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Status Code Sk
DescriptionIndicates the phase in the lifecycle of the activity as part of a global library.

For example:
Draft New
Released
Retired
Archived
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Status Dt
DescriptionThe date and time the status for an activity as part of a study or clinical trial is defined.
Data TypeStandards - Data Domains.ddm/Data Domains/Date Time [TIMESTAMP]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Study Accrual Threshold Pct
DescriptionAn integer specifying a percentage of target accrual for a study, which when reached triggers a notification.

For example:
75% or 90% of the target accrual number.
Data TypeStandards - Data Domains.ddm/Data Domains/Percentage [FLOAT(2)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Study Day Range Qty
DescriptionThe 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 TypeStandards - Data Domains.ddm/Data Domains/Quantity Integer [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Study Dk
DescriptionA numeric surrogate key used to uniquely identify entities in the dimensional model.
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key Large [LONG]
Is Part Of PrimaryKeyfalse
Is Requiredtrue
Is Derivedfalse
Is Surrogate Keyfalse



 Study Focus Ind
DescriptionSpecifies whether the activity is a key investigational activity for a study. If a study has study agents, one or more of the study activities will presumably use the agent and have this indicator set to true.

For example:
A study focused on investigating the effectiveness of a drug will flag the substance administration of the drug or a study focused on determining the average blood pressure of a certain population will flag the blood pressure observation.
Data TypeStandards - Data Domains.ddm/Data Domains/Boolean Indicator [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Study Protocol Dk
DescriptionA numeric surrogate key used to uniquely identify entities in the dimensional model.
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key Large [LONG]
Is Part Of PrimaryKeyfalse
Is Requiredtrue
Is Derivedfalse
Is Surrogate Keyfalse



 Study Protocol Sk
DescriptionA numeric surrogate key used to uniquely identify entities in the atomic model.
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key Large [LONG]
Is Part Of PrimaryKeyfalse
Is Requiredtrue
Is Derivedfalse
Is Surrogate Keyfalse



 Study Reference From Ts
DescriptionThe date (and time) used to indicate the start of the study for a subject.
Data TypeStandards - Data Domains.ddm/Data Domains/Date [DATE]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Study Reference To Ts
DescriptionThe date (and time) used to indicate the end of the study for a subject.
Data TypeStandards - Data Domains.ddm/Data Domains/Date [DATE]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Study Site Accrual Threshold Pct
DescriptionAn integer specifying a percentage of target accrual at a particular study site, which when reached triggers a notification.

For example:
75% or 90% of the target accrual number.
Data TypeStandards - Data Domains.ddm/Data Domains/Percentage [FLOAT(2)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Study Site Dk
DescriptionA numeric surrogate key used to uniquely identify entities in the dimensional model.
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key Large [LONG]
Is Part Of PrimaryKeyfalse
Is Requiredtrue
Is Derivedfalse
Is Surrogate Keyfalse



 Study Site Sk
DescriptionA numeric surrogate key used to uniquely identify entities in the atomic model.
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key Large [LONG]
Is Part Of PrimaryKeyfalse
Is Requiredtrue
Is Derivedfalse
Is Surrogate Keyfalse



 Study Sk
DescriptionA numeric surrogate key used to uniquely identify entities in the atomic model.
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key Large [LONG]
Is Part Of PrimaryKeyfalse
Is Requiredtrue
Is Derivedfalse
Is Surrogate Keyfalse



 Study Subject Dk
DescriptionA numeric surrogate key used to uniquely identify entities in the dimensional model.
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key Large [LONG]
Is Part Of PrimaryKeyfalse
Is Requiredtrue
Is Derivedfalse
Is Surrogate Keyfalse



 Study Subject Sk
DescriptionA numeric surrogate key used to uniquely identify entities in the atomic model.
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key Large [LONG]
Is Part Of PrimaryKeyfalse
Is Requiredtrue
Is Derivedfalse
Is Surrogate Keyfalse



 Subcategory Cd
DescriptionSpecifies a subdivision within a larger category of activities.

For example:
Chemotherapy
Radiotherapy
Hormonal therapy
Alternative therapy
Data TypeStandards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Subcategory Code Sk
DescriptionSpecifies a subdivision within a larger category of activities.

For example:
Chemotherapy
Radiotherapy
Hormonal therapy
Alternative therapy
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Substance Unknown Ind
DescriptionSpecifies whether the substance administered was not known.
Data TypeStandards - Data Domains.ddm/Data Domains/Boolean Indicator [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Target Anatomic Site Cd
DescriptionSpecifies 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 TypeStandards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Target Anatomic Site Code Sk
DescriptionSpecifies 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 TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Target Anatomic Site Laterality Cd
DescriptionSpecifies the side of the body (or a paired organ) that is a target site for an observation.

For example:
Bilateral
Left
Right
Data TypeStandards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Target Anatomic Site Laterality Code Sk
DescriptionSpecifies the side of the body (or a paired organ) that is a target site for an observation.

For example:
Bilateral
Left
Right
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Temperature Range Txt
DescriptionThe thermal reading at which the storage unit was set.

For example:
gt -80 degrees celsius
-135 to -80 degrees celsius
Data TypeStandards - Data Domains.ddm/Data Domains/Text Small [VARCHAR(50)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Tenant Sk
DescriptionThe surrogate key of the entry identifying the legal owner of the data.
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredtrue
Is Derivedfalse
Is Surrogate Keyfalse



 Transfer Qty
DescriptionThe amount and unit of study agent transferred in standard or canonical units.
Data TypeStandards - Data Domains.ddm/Data Domains/Quantity Integer [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Treatment Vehicle Qty
DescriptionThe quantity and units of treatment vehicle used.

For example:
10 milligrams
2 milliliters
Data TypeStandards - Data Domains.ddm/Data Domains/Quantity Integer [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Valid From Ts
DescriptionEstablishes 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 TypeStandards - Data Domains.ddm/Data Domains/Timestamp [TIMESTAMP]
Is Part Of PrimaryKeyfalse
Is Requiredtrue
Is Derivedfalse
Is Surrogate Keyfalse



 Valid To Ts
DescriptionEnds a period of validity.
Data TypeStandards - Data Domains.ddm/Data Domains/Timestamp [TIMESTAMP]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Variance Reason Cd
DescriptionDescribes why what occurred is different from what was expected.

For example:
Subject received early treatment because of vacation plans.
Data TypeStandards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Variance Reason Code Sk
DescriptionDescribes why what occurred is different from what was expected.

For example:
Subject received early treatment because of vacation plans.
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Variance Type Cd
DescriptionSpecifies the kind of variance.

For example:
Early / late occurrence of an act
Higher / lower amount transferred
Data TypeStandards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Variance Type Code Sk
DescriptionSpecifies the kind of variance.

For example:
Early / late occurrence of an act
Higher / lower amount transferred
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse

Relationship Details

 Activity Fact_Product Dimension_FK
Is Identifying Relationshipfalse
Child TableActivity Fact
Child MultiplicityZERO_TO_MANY
Child Referential Integrity: On DeleteNONE
Child Referential Integrity: On InsertNONE
Child Referential Integrity: On UpdateNONE
Parent TableProduct Dimension
Parent MultiplicityONE
Parent Referential Integrity: On DeleteNONE
Parent Referential Integrity: On InsertNONE
Parent Referential Integrity: On UpdateNONE



 Activity Fact_Experimental Unit Dimension_FK
Is Identifying Relationshipfalse
Child TableActivity Fact
Child MultiplicityZERO_TO_MANY
Child Referential Integrity: On DeleteNONE
Child Referential Integrity: On InsertNONE
Child Referential Integrity: On UpdateNONE
Parent TableExperimental Unit Dimension
Parent MultiplicityONE
Parent Referential Integrity: On DeleteNONE
Parent Referential Integrity: On InsertNONE
Parent Referential Integrity: On UpdateNONE



 Activity Fact_Organization Dimension_FK
Is Identifying Relationshipfalse
Child TableActivity Fact
Child Role Nameperforming
Child MultiplicityZERO_TO_MANY
Child Referential Integrity: On DeleteNONE
Child Referential Integrity: On InsertNONE
Child Referential Integrity: On UpdateNONE
Parent TableOrganization Dimension
Parent MultiplicityONE
Parent Referential Integrity: On DeleteNONE
Parent Referential Integrity: On InsertNONE
Parent Referential Integrity: On UpdateNONE



 Activity Fact_Practitioner Dimension_FK
Is Identifying Relationshipfalse
Child TableActivity Fact
Child Role Namenotified
Child MultiplicityZERO_TO_MANY
Child Referential Integrity: On DeleteNONE
Child Referential Integrity: On InsertNONE
Child Referential Integrity: On UpdateNONE
Parent TablePractitioner Dimension
Parent MultiplicityONE
Parent Referential Integrity: On DeleteNONE
Parent Referential Integrity: On InsertNONE
Parent Referential Integrity: On UpdateNONE



 Activity Fact_Point Of Care Location Dimension_FK
Is Identifying Relationshipfalse
Child TableActivity Fact
Child MultiplicityZERO_TO_MANY
Child Referential Integrity: On DeleteNONE
Child Referential Integrity: On InsertNONE
Child Referential Integrity: On UpdateNONE
Parent TablePoint Of Care Location Dimension
Parent MultiplicityONE
Parent Referential Integrity: On DeleteNONE
Parent Referential Integrity: On InsertNONE
Parent Referential Integrity: On UpdateNONE



 Activity Fact_Document Dimension_FK
Is Identifying Relationshipfalse
Child TableActivity Fact
Child MultiplicityZERO_TO_MANY
Child Referential Integrity: On DeleteNONE
Child Referential Integrity: On InsertNONE
Child Referential Integrity: On UpdateNONE
Parent TableDocument Dimension
Parent MultiplicityONE
Parent Referential Integrity: On DeleteNONE
Parent Referential Integrity: On InsertNONE
Parent Referential Integrity: On UpdateNONE



 Activity Fact_Person Dimension_FK
Is Identifying Relationshipfalse
Child TableActivity Fact
Child Role Nameperforming
Child MultiplicityZERO_TO_MANY
Child Referential Integrity: On DeleteNONE
Child Referential Integrity: On InsertNONE
Child Referential Integrity: On UpdateNONE
Parent TablePerson Dimension
Parent MultiplicityONE
Parent Referential Integrity: On DeleteNONE
Parent Referential Integrity: On InsertNONE
Parent Referential Integrity: On UpdateNONE



 Activity Fact_Person Dimension_FK1
Is Identifying Relationshipfalse
Child TableActivity Fact
Child Role Namenotified
Child MultiplicityZERO_TO_MANY
Child Referential Integrity: On DeleteNONE
Child Referential Integrity: On InsertNONE
Child Referential Integrity: On UpdateNONE
Parent TablePerson Dimension
Parent MultiplicityONE
Parent Referential Integrity: On DeleteNONE
Parent Referential Integrity: On InsertNONE
Parent Referential Integrity: On UpdateNONE



 Activity Fact_Organization Dimension_FK1
Is Identifying Relationshipfalse
Child TableActivity Fact
Child Role Namenotified
Child MultiplicityZERO_TO_MANY
Child Referential Integrity: On DeleteNONE
Child Referential Integrity: On InsertNONE
Child Referential Integrity: On UpdateNONE
Parent TableOrganization Dimension
Parent MultiplicityONE
Parent Referential Integrity: On DeleteNONE
Parent Referential Integrity: On InsertNONE
Parent Referential Integrity: On UpdateNONE



 Activity Fact_Calendar Dimension_FK
Is Identifying Relationshipfalse
Child TableActivity Fact
Child MultiplicityZERO_TO_MANY
Child Referential Integrity: On DeleteNONE
Child Referential Integrity: On InsertNONE
Child Referential Integrity: On UpdateNONE
Parent TableCalendar Dimension
Parent MultiplicityONE
Parent Referential Integrity: On DeleteNONE
Parent Referential Integrity: On InsertNONE
Parent Referential Integrity: On UpdateNONE



 Activity Fact_Study Protocol Dimension_FK
Is Identifying Relationshipfalse
Child TableActivity Fact
Child Role Namerequired by
Child MultiplicityZERO_TO_MANY
Child Referential Integrity: On DeleteNONE
Child Referential Integrity: On InsertNONE
Child Referential Integrity: On UpdateNONE
Parent TableStudy Protocol Dimension
Parent MultiplicityONE
Parent Referential Integrity: On DeleteNONE
Parent Referential Integrity: On InsertNONE
Parent Referential Integrity: On UpdateNONE



 Activity Fact_Protocol Arm Dimension_FK
Is Identifying Relationshipfalse
Child TableActivity Fact
Child Role Nameperformed in
Child MultiplicityZERO_TO_MANY
Child Referential Integrity: On DeleteNONE
Child Referential Integrity: On InsertNONE
Child Referential Integrity: On UpdateNONE
Parent TableProtocol Arm Dimension
Parent MultiplicityONE
Parent Referential Integrity: On DeleteNONE
Parent Referential Integrity: On InsertNONE
Parent Referential Integrity: On UpdateNONE



 Activity Fact_Epoch_FK
Is Identifying Relationshipfalse
Child TableActivity Fact
Child Role Namecomponent of
Child MultiplicityZERO_TO_MANY
Child Referential Integrity: On DeleteNONE
Child Referential Integrity: On InsertNONE
Child Referential Integrity: On UpdateNONE
Parent TableEpoch Dimension
Parent MultiplicityONE
Parent Referential Integrity: On DeleteNONE
Parent Referential Integrity: On InsertNONE
Parent Referential Integrity: On UpdateNONE



 Activity Fact_Study Dimension_FK
Is Identifying Relationshipfalse
Child TableActivity Fact
Child MultiplicityZERO_TO_MANY
Child Referential Integrity: On DeleteNONE
Child Referential Integrity: On InsertNONE
Child Referential Integrity: On UpdateNONE
Parent TableStudy Dimension
Parent MultiplicityONE
Parent Referential Integrity: On DeleteNONE
Parent Referential Integrity: On InsertNONE
Parent Referential Integrity: On UpdateNONE



 Activity Fact_Study Subject Dimension_FK
Is Identifying Relationshipfalse
Child TableActivity Fact
Child MultiplicityZERO_TO_MANY
Child Referential Integrity: On DeleteNONE
Child Referential Integrity: On InsertNONE
Child Referential Integrity: On UpdateNONE
Parent TableStudy Subject Dimension
Parent MultiplicityONE
Parent Referential Integrity: On DeleteNONE
Parent Referential Integrity: On InsertNONE
Parent Referential Integrity: On UpdateNONE



 Activity Fact_Specimen Dimension_FK
Is Identifying Relationshipfalse
Child TableActivity Fact
Child MultiplicityZERO_TO_MANY
Child Referential Integrity: On DeleteNONE
Child Referential Integrity: On InsertNONE
Child Referential Integrity: On UpdateNONE
Parent TableSpecimen Dimension
Parent MultiplicityONE
Parent Referential Integrity: On DeleteNONE
Parent Referential Integrity: On InsertNONE
Parent Referential Integrity: On UpdateNONE



 Activity Fact_Study Site Dimension_FK
Is Identifying Relationshipfalse
Child TableActivity Fact
Child MultiplicityZERO_TO_MANY
Child Referential Integrity: On DeleteNONE
Child Referential Integrity: On InsertNONE
Child Referential Integrity: On UpdateNONE
Parent TableStudy Site Dimension
Parent MultiplicityONE
Parent Referential Integrity: On DeleteNONE
Parent Referential Integrity: On InsertNONE
Parent Referential Integrity: On UpdateNONE

Primary Key Details

 Activity Fact PK
Key AttributeActivity Fact Dk