Date Range QtyDate Range Validation TypeDelay Duration QtyFasting Status IndMedical History IndNegation IndNegation ReasonRepetition QtyStudy Day Range Qty
| Business Data Model Data Model |
| 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 | |
| Date Range Qty |
|
| Date Range Validation Type |
|
| Delay Duration Qty |
|
| Fasting Status Ind |
|
| Medical History Ind |
|
| Negation Ind |
|
| Negation Reason |
|
| Repetition Qty |
|
| Study Day Range Qty |
|
| Generalization | |
 R_1305 |
|
| Dependencies | |
 NONE |
|
| Reverse Dependencies | |
| |
|
| Attribute Details |
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 Type
| 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/Enumeration [VARCHAR(20)] |
| 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 |
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 |
Medical History Ind
| Description | Specifies whether the activity is considered part of the historical record of a subject, that is, it did not occur within the bounds of the study. |
| Data Type | Standards - Data Domains.ddm/Data Domains/Boolean Indicator [INTEGER] |
| Is Part Of PrimaryKey | false |
| Is Required | false |
| Is Derived | false |
| Is Surrogate Key | false |
Negation Ind
| Description | Specifies whether an activity did not occur. For example: If a subject did not take aspirin in the previous week, the negation indicator = "true". |
| Data Type | Standards - Data Domains.ddm/Data Domains/Boolean Indicator [INTEGER] |
| Is Part Of PrimaryKey | false |
| Is Required | false |
| Is Derived | false |
| Is Surrogate Key | false |
Negation Reason
| Description | The text, code, or both, that describe 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 |
Repetition Qty
| Description | An integer that identifies the occurrence of a repeating activity. The first repetition is defined as '1'. For example: A planned activity can have a repeat quantity of 4, which results in four scheduled activities and performed activities with repetition numbers of 1, 2, 3, and 4 (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 |
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 |
| Relationship Details |
triggeredPerformedActivity
| Is Identifying Relationship | false |
| Child Table | Performed Activity |
| Child Role Name | triggeringObservationResultActionTakenRelationship |
| Child Multiplicity | ZERO_TO_MANY |
| Child Referential Integrity: On Delete | SET_NULL |
| Child Referential Integrity: On Insert | NONE |
| Child Referential Integrity: On Update | SET_NULL |
| Parent Table | Observation Result Action Taken |
| Parent Role Name | triggeredPerformedActivity |
| Parent Multiplicity | ZERO_TO_ONE |
| Parent Referential Integrity: On Delete | NONE |
| Parent Referential Integrity: On Insert | SET_NULL |
| Parent Referential Integrity: On Update | SET_NULL |
instantiatingPerformedActivity/1
| Description | |
| Is Identifying Relationship | false |
| Child Table | Performed Activity |
| Child Role Name | instantiatedPlannedActivity |
| Child Multiplicity | ZERO_TO_MANY |
| Child Referential Integrity: On Delete | SET_NULL |
| Child Referential Integrity: On Insert | NONE |
| Child Referential Integrity: On Update | SET_NULL |
| Parent Table | Planned Activity |
| Parent Role Name | instantiatingPerformedActivity |
| Parent Multiplicity | ZERO_TO_ONE |
| Parent Referential Integrity: On Delete | NONE |
| Parent Referential Integrity: On Insert | SET_NULL |
| Parent Referential Integrity: On Update | SET_NULL |
executedPerformedActivity
| Description | |
| Is Identifying Relationship | false |
| Child Table | Performed Activity |
| Child Role Name | versionStudyProtocolVersion |
| Child Multiplicity | ZERO_TO_MANY |
| Child Referential Integrity: On Delete | SET_NULL |
| Child Referential Integrity: On Insert | NONE |
| Child Referential Integrity: On Update | SET_NULL |
| Parent Table | Study Protocol |
| Parent Role Name | executedPerformedActivity |
| Parent Multiplicity | ZERO_TO_ONE |
| Parent Referential Integrity: On Delete | NONE |
| Parent Referential Integrity: On Insert | SET_NULL |
| Parent Referential Integrity: On Update | SET_NULL |
containedPerformedActivity
| Is Identifying Relationship | false |
| Child Table | Performed Activity |
| Child Role Name | containingEpoch |
| Child Multiplicity | ZERO_TO_MANY |
| Child Referential Integrity: On Delete | SET_NULL |
| Child Referential Integrity: On Insert | NONE |
| Child Referential Integrity: On Update | SET_NULL |
| Parent Table | Epoch |
| Parent Role Name | containedPerformedActivity |
| Parent Multiplicity | ZERO_TO_ONE |
| Parent Referential Integrity: On Delete | NONE |
| Parent Referential Integrity: On Insert | SET_NULL |
| Parent Referential Integrity: On Update | SET_NULL |
evaluatedPerformedActivity
| Description | |
| Is Identifying Relationship | false |
| Child Table | Performed Activity |
| Child Role Name | evaluatingEvaluatedActivityRelationship |
| Child Multiplicity | ZERO_TO_MANY |
| Child Referential Integrity: On Delete | SET_NULL |
| Child Referential Integrity: On Insert | NONE |
| Child Referential Integrity: On Update | SET_NULL |
| Parent Table | Evaluated Activity |
| Parent Role Name | evaluatedPerformedActivity |
| Parent Multiplicity | ZERO_TO_ONE |
| Parent Referential Integrity: On Delete | NONE |
| Parent Referential Integrity: On Insert | SET_NULL |
| Parent Referential Integrity: On Update | SET_NULL |
assessedPerformedActivity
| Description | |
| Is Identifying Relationship | false |
| Child Table | Performed Activity |
| Child Role Name | assessingAssessedActivityRelationship |
| Child Multiplicity | ZERO_TO_MANY |
| Child Referential Integrity: On Delete | SET_NULL |
| Child Referential Integrity: On Insert | NONE |
| Child Referential Integrity: On Update | SET_NULL |
| Parent Table | Assessed Activity |
| Parent Role Name | assessedPerformedActivity |
| Parent Multiplicity | ZERO_TO_ONE |
| Parent Referential Integrity: On Delete | NONE |
| Parent Referential Integrity: On Insert | SET_NULL |
| Parent Referential Integrity: On Update | SET_NULL |
PerformedActivity_Location_FK
| Is Identifying Relationship | false |
| Child Table | Performed Activity |
| 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 | Location |
| Parent Multiplicity | ZERO_TO_ONE |
| Parent Referential Integrity: On Delete | NONE |
| Parent Referential Integrity: On Insert | NONE |
| Parent Referential Integrity: On Update | NONE |
| Generalization Details |
R_1305
| Supertype | Activity |
| Subtype | Performed Activity |
| Transform As | TABLE |
| Business Data Model Data Model |