| Business Data Model Data Model |
| Description | A performed activity that applies, introduces or otherwise gives medications or other substances to the subject or experimental unit. For example: An experimental unit who receives methotrexate as part of chemotherapy, radiation therapy. |
| Relationship | |
 PerformedSubstanceAdministration (Med Admin)_Activity Procedure Observation (Clin Finding)_FK |
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| Generalization | |
 Generalization1 |
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| Dependencies | |
 NONE |
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| Reverse Dependencies | |
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| Attribute Details |
Active Ingredient Dose Descr
| Description | The textual representation of active ingredients in the dosing amounts or a range of dosing information used in a substance administration. For example: 200-400 |
| Data Type | Standards - Data Domains.ddm/Data Domains/Text Large [VARCHAR(1024)] |
| Is Part Of PrimaryKey | false |
| Is Required | false |
| Is Derived | false |
| Is Surrogate Key | false |
Active Ingredient Dose Qty
| Description | The quantity of active ingredients used in a substance administration. For example: 5 mg |
| Data Type | Standards - Data Domains.ddm/Data Domains/Quantity Integer [INTEGER] |
| Is Part Of PrimaryKey | false |
| Is Required | false |
| Is Derived | false |
| Is Surrogate Key | false |
Change Reason Txt
| Description | The rationale for changing the substance administration in relation to the previous substance administration. For example: Dose reduced due to hematologic toxicity |
| Data Type | Standards - Data Domains.ddm/Data Domains/Text Large [VARCHAR(1024)] |
| Is Part Of PrimaryKey | false |
| Is Required | false |
| Is Derived | false |
| Is Surrogate Key | false |
Distinct Product Cnt
| Description | The number of products (resulting from different collections) used for this substance administration. This is a count of distinct donations, typically used for stem cell transplants. For example: If blood is taken from 2 people (two donations from one of them), this would be counted as 3 different collections. |
| Data Type | Standards - Data Domains.ddm/Data Domains/Count [INTEGER] |
| Is Part Of PrimaryKey | false |
| Is Required | false |
| Is Derived | false |
| Is Surrogate Key | false |
Donor Type
| Description | Specifies the kind of donor that is used. For example: Syngeneic HLA-identical sibling HLA-matched other relative HLA-mismatched relative Unrelated donor |
| Data Type | Standards - Data Domains.ddm/Data Domains/Enumeration [VARCHAR(20)] |
| Is Part Of PrimaryKey | false |
| Is Required | false |
| Is Derived | false |
| Is Surrogate Key | false |
Dose Frequency
| Description | Specifies how often doses are administered. Used to capture multiple substance administrations in one act, rather than each time a patient swallows a pill, for example "The patient took med X 3 times a day for 10 days starting on June 9th". For example: BID TID QID |
| Data Type | Standards - Data Domains.ddm/Data Domains/Enumeration [VARCHAR(20)] |
| Is Part Of PrimaryKey | false |
| Is Required | false |
| Is Derived | false |
| Is Surrogate Key | false |
Dose Period
| Description | Specifies the period during which the dose total is administered. For example: Daily Course |
| 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 |
End Relative To Reference
| Description | Specifies when this event ended with respect to the sponsor-defined reference period. For example: Before During During/after After |
| Data Type | Standards - Data Domains.ddm/Data Domains/Enumeration [VARCHAR(20)] |
| Is Part Of PrimaryKey | false |
| Is Required | false |
| Is Derived | false |
| Is Surrogate Key | false |
Flow Rate
| Description | A ratio specifying the speed with which the substance is introduced into the subject. For example: 100 mL/h 1 g/d 40 mmol/h |
| Data Type | Standards - Data Domains.ddm/Data Domains/Rate [FLOAT(5)] |
| Is Part Of PrimaryKey | false |
| Is Required | false |
| Is Derived | false |
| Is Surrogate Key | false |
Interruption Duration Qty
| Description | The period of time during which a substance administration is interrupted. For example: An infusion started at 12:15pm and ended at 2:37pm, but there was an interruption of 17 minutes. |
| Data Type | Standards - Data Domains.ddm/Data Domains/Quantity Integer [INTEGER] |
| Is Part Of PrimaryKey | false |
| Is Required | false |
| Is Derived | false |
| Is Surrogate Key | false |
Period Active Ingredient Dose Total Qty
| Description | The total amount of active ingredient in all doses of treatment in a given period of time. |
| Data Type | Standards - Data Domains.ddm/Data Domains/Quantity Integer [INTEGER] |
| Is Part Of PrimaryKey | false |
| Is Required | false |
| Is Derived | false |
| Is Surrogate Key | false |
Period Product Dose Total Qty
| Description | The total of all doses of treatment in a given period of time. The given period of time is defined in Dose Period. |
| Data Type | Standards - Data Domains.ddm/Data Domains/Quantity Integer [INTEGER] |
| Is Part Of PrimaryKey | false |
| Is Required | false |
| Is Derived | false |
| Is Surrogate Key | false |
Planned Change Ind
| Description | Specifies whether a change in the substance administration in relation to the previous substance administration is planned or not. For example: True = planned False = unplanned |
| Data Type | Standards - Data Domains.ddm/Data Domains/Boolean Indicator [INTEGER] |
| Is Part Of PrimaryKey | false |
| Is Required | false |
| Is Derived | false |
| Is Surrogate Key | false |
Product Dose Descr
| Description | The textual representation of dosing amounts or a range of dosing information used in a substance administration. For example: 200-400 |
| Data Type | Standards - Data Domains.ddm/Data Domains/Text Large [VARCHAR(1024)] |
| Is Part Of PrimaryKey | false |
| Is Required | false |
| Is Derived | false |
| Is Surrogate Key | false |
Product Dose Qty
| Description | The quantity of a substance or medication to be administered. For example: 5 mg 20 mg of drug per kg of subject weight |
| Data Type | Standards - Data Domains.ddm/Data Domains/Quantity Integer [INTEGER] |
| Is Part Of PrimaryKey | false |
| Is Required | false |
| Is Derived | false |
| Is Surrogate Key | false |
Relation Type
| Description | Specifies the self-relationship of the source to the target. For example: Autologous (self) Allogeneic-related Allogeneic Unrelated |
| Data Type | Standards - Data Domains.ddm/Data Domains/Enumeration [VARCHAR(20)] |
| Is Part Of PrimaryKey | false |
| Is Required | false |
| Is Derived | false |
| Is Surrogate Key | false |
Route Type
| Description | Identifies the route of administration. For example: Apply Externally Buccal Dental Intravenous Oral Intra-arterial |
| 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 |
Standard Time Ind
| Description | Specifies whether the time of the substance administration is specified using standard (as opposed to daylight savings) time. If the location and date are known, this data is derivable. |
| Data Type | Standards - Data Domains.ddm/Data Domains/Boolean Indicator [INTEGER] |
| Is Part Of PrimaryKey | false |
| Is Required | false |
| Is Derived | false |
| Is Surrogate Key | false |
Start Relative To Reference
| Description | Specifies when this event started with respect to the sponsor-defined reference period. Medications that are ongoing at the end of the reference period should have a value of "during/after". For example: Before During During/after After |
| Data Type | Standards - Data Domains.ddm/Data Domains/Enumeration [VARCHAR(20)] |
| Is Part Of PrimaryKey | false |
| Is Required | false |
| Is Derived | false |
| Is Surrogate Key | false |
Substance Administration Change Type
| Description | Specifies the modification of the substance administration in relation to the previous substance administration. For example: Agent Added Agent Dose Decreased Agent Dose Increased |
| Data Type | Standards - Data Domains.ddm/Data Domains/Enumeration [VARCHAR(20)] |
| Is Part Of PrimaryKey | false |
| Is Required | false |
| Is Derived | false |
| Is Surrogate Key | false |
Substance Unknown Ind
| Description | Specifies whether the substance administered was not known. |
| Data Type | Standards - Data Domains.ddm/Data Domains/Boolean Indicator [INTEGER] |
| Is Part Of PrimaryKey | false |
| Is Required | false |
| Is Derived | false |
| Is Surrogate Key | false |
Treatment Vehicle Qty
| Description | The quantity and units of treatment vehicle used. For example: 10 milligrams 2 milliliters |
| Data Type | Standards - Data Domains.ddm/Data Domains/Quantity Integer [INTEGER] |
| Is Part Of PrimaryKey | false |
| Is Required | false |
| Is Derived | false |
| Is Surrogate Key | false |
| Relationship Details |
PerformedSubstanceAdministration (Med Admin)_Activity Procedure Observation (Clin Finding)_FK
| Is Identifying Relationship | true |
| Child Table | Substance Administration |
| 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 Observation |
| Parent Multiplicity | ONE |
| Parent Referential Integrity: On Delete | NONE |
| Parent Referential Integrity: On Insert | NONE |
| Parent Referential Integrity: On Update | NONE |
| Generalization Details |
Generalization1
| Supertype | Performed Activity |
| Subtype | Substance Administration |
| Transform As | TABLE |
| Business Data Model Data Model |