| Business Data Model Data Model |
| Description | An 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. |
| Dependencies | |
 NONE |
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| Reverse Dependencies | |
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| Attribute Details |
Activity Category
| Description | Classification of activities. For example: In the case where Category Code = "anti-cancer treatment", the Sub Category Code may = "radiotherapy" and the Name Code may = "external beam radiotherapy". |
| Data Type | Standards - Data Domains.ddm/Data Domains/Enumeration [VARCHAR(20)] |
| Is Part Of PrimaryKey | false |
| Is Required | false |
| Is Derived | false |
| Is Surrogate Key | false |
Activity Reason
| Description | A coded value specifying the motivation, cause, or rationale of an activity. For example: Routine requirement Drug reaction Infectious disease reporting requirement On patient request |
| Data Type | Standards - Data Domains.ddm/Data Domains/Enumeration [VARCHAR(20)] |
| Is Part Of PrimaryKey | false |
| Is Required | false |
| Is Derived | false |
| Is Surrogate Key | false |
Activity Status
| Description | Indicates the phase in the lifecycle of the activity as part of a global library. For example: Draft New Released Retired Archived |
| Data Type | Standards - Data Domains.ddm/Data Domains/Enumeration [VARCHAR(20)] |
| Is Part Of PrimaryKey | false |
| Is Required | false |
| Is Derived | false |
| Is Surrogate Key | false |
Activity Status Change Reason
| Description | Specifies why the status has changed. |
| 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 |
Activity Subcategory
| Description | Specifies a subdivision within a larger category of activities. For example: Chemotherapy Radiotherapy Hormonal therapy Alternative therapy |
| Data Type | Standards - Data Domains.ddm/Data Domains/Enumeration [VARCHAR(20)] |
| Is Part Of PrimaryKey | false |
| Is Required | false |
| Is Derived | false |
| Is Surrogate Key | false |
Clinical Trial Activity Name
| Description | The text description of an activity within a clinical trial or study. |
| Data Type | Standards - Data Domains.ddm/Data Domains/Text Large [VARCHAR(1024)] |
| Is Part Of PrimaryKey | false |
| Is Required | false |
| Is Derived | false |
| Is Surrogate Key | false |
Clinical Trial Activity Status Date and Time
| Description | The date and time the status for an activity as part of a study or clinical trial is defined. |
| Data Type | Standards - Data Domains.ddm/Data Domains/Date Time [TIMESTAMP] |
| Is Part Of PrimaryKey | false |
| Is Required | false |
| Is Derived | false |
| Is Surrogate Key | false |
Comment Txt
| Description | Additional description of the activity. For example: Guidance on how to perform the observation. |
| Data Type | Standards - Data Domains.ddm/Data Domains/Text Large [VARCHAR(1024)] |
| Is Part Of PrimaryKey | false |
| Is Required | false |
| Is Derived | false |
| Is Surrogate Key | false |
Description Txt
| Description | The textual representation of the activity. |
| Data Type | Standards - Data Domains.ddm/Data Domains/Text Large [VARCHAR(1024)] |
| Is Part Of PrimaryKey | false |
| Is Required | false |
| Is Derived | false |
| Is Surrogate Key | false |
Duration Qty
| Description | The intended period of time for the planned activity as defined by the study. For example: 6 weeks may be the planned duration for a composite activity that represents the activities occurring during an epoch on arm A. |
| Data Type | Standards - Data Domains.ddm/Data Domains/Quantity Integer [INTEGER] |
| Is Part Of PrimaryKey | false |
| Is Required | false |
| Is Derived | false |
| Is Surrogate Key | false |
Identification Num
| Description | A unique symbol that establishes identity of an activity. For example: 12345 is the identifier for a substance administration |
| Data Type | Standards - Data Domains.ddm/Data Domains/Alphanumeric [VARCHAR(80)] |
| Is Part Of PrimaryKey | false |
| Is Required | false |
| Is Derived | false |
| Is Surrogate Key | false |
Repeat Duration Qty
| Description | The period of time over which the activity is repeated. |
| Data Type | Standards - Data Domains.ddm/Data Domains/Quantity Integer [INTEGER] |
| Is Part Of PrimaryKey | false |
| Is Required | false |
| Is Derived | false |
| Is Surrogate Key | false |
Repeat Frequency
| Description | The repeating frequency with which the treatment is to be administered. It is similar to the frequency and SIG code tables used in order entry systems. |
| Data Type | Standards - Data Domains.ddm/Data Domains/Enumeration [VARCHAR(20)] |
| Is Part Of PrimaryKey | false |
| Is Required | false |
| Is Derived | false |
| Is Surrogate Key | false |
Repeat Frequency Ratio
| Description | A ratio representing the number of occurrences of an activity within a given time period. For example: Once per 12 hours 2 times per day |
| Data Type | Standards - Data Domains.ddm/Data Domains/Ratio [FLOAT(5)] |
| Is Part Of PrimaryKey | false |
| Is Required | false |
| Is Derived | false |
| Is Surrogate Key | false |
| Business Data Model Data Model |