| Dimensional Warehouse 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. |
Primary Key | |
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Dependencies | |
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Reverse Dependencies | |
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Attribute Details |
Description | Concatenated values of a set of business attributes that uniquely identify the row. |
Data Type | Standards - Data Domains.ddm/Data Domains/Business Key [VARCHAR(255)] |
Is Part Of PrimaryKey | false |
Is Required | true |
Is Derived | false |
Is Surrogate Key | false |
Description | A numeric surrogate key used to uniquely identify entities in the dimensional model. |
Data Type | Standards - Data Domains.ddm/Data Domains/Surrogate Key Large [LONG] |
Is Part Of PrimaryKey | true |
Is Required | true |
Is Derived | false |
Is Surrogate Key | true |
Description | A numeric surrogate key used to uniquely identify entities in the atomic model. |
Data Type | Standards - Data Domains.ddm/Data Domains/Surrogate Key Large [LONG] |
Is Part Of PrimaryKey | false |
Is Required | true |
Is Derived | false |
Is Surrogate Key | false |
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 |
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 |
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 |
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/Tenant Common Code [VARCHAR(80)] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
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/Surrogate Key [INTEGER] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
Description | Specifies the period during which the dose total is administered. For example: Daily Course |
Data Type | Standards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
Description | Specifies the period during which the dose total is administered. For example: Daily Course |
Data Type | Standards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
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 |
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 |
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 |
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 |
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 |
Description | Identifies the route of administration. For example: Apply Externally Buccal Dental Intravenous Oral Intra-arterial |
Data Type | Standards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
Description | Identifies the route of administration. For example: Apply Externally Buccal Dental Intravenous Oral Intra-arterial |
Data Type | Standards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
Description | Identifies 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 Type | Standards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
Description | Identifies 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 Type | Standards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
Description | Identifies 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 Type | Standards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
Description | Identifies 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 Type | Standards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
Description | Specifies 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 Type | Standards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
Description | Specifies 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 Type | Standards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
Description | The surrogate key of the load information entry describing the details regarding the loading of the row in the atomic data warehouse. |
Data Type | Standards - Data Domains.ddm/Data Domains/Surrogate Key Large [LONG] |
Is Part Of PrimaryKey | false |
Is Required | true |
Is Derived | false |
Is Surrogate Key | false |
Description | The 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 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 | A numeric surrogate key used to uniquely identify entities in the dimensional model. |
Data Type | Standards - Data Domains.ddm/Data Domains/Surrogate Key Large [LONG] |
Is Part Of PrimaryKey | false |
Is Required | true |
Is Derived | false |
Is Surrogate Key | false |
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/Tenant Common Code [VARCHAR(80)] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
Description | Classification of activities. For example: In the case where Category Code = "anti-cancer treatment", the Sub Category Code may = "radiotherapy" and the Name Code may = "external beam radiotherapy". |
Data Type | Standards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
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 |
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/Tenant Common Code [VARCHAR(80)] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
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/Surrogate Key [INTEGER] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
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 | Set to 'Y' if this is the most recent row of a group having the same Surrogate Key. |
Data Type | Standards - Data Domains.ddm/Data Domains/Boolean Indicator [INTEGER] |
Is Part Of PrimaryKey | false |
Is Required | true |
Is Derived | false |
Is Surrogate Key | false |
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 |
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/Tenant Common Code [VARCHAR(80)] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
Description | Specifies the degree of authoritativeness or certitude of the date of the activity. For example: Date estimated Date greater than 100 days - day is correct |
Data Type | Standards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
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/Tenant Common Code [VARCHAR(80)] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
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/Surrogate Key [INTEGER] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
Description | Specifies the period during which the dose total is administered. For example: Daily Course |
Data Type | Standards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
Description | Specifies the period during which the dose total is administered. For example: Daily Course |
Data Type | Standards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
Description | Text 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 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 | 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 |
Description | The subject of the notification. |
Data Type | Standards - Data Domains.ddm/Data Domains/Text Large [VARCHAR(1024)] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
Description | The 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 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 | Total 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 Type | Standards - Data Domains.ddm/Data Domains/Quantity Integer [INTEGER] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
Description | 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 |
Description | Identifies the route of administration. For example: Apply Externally Buccal Dental Intravenous Oral Intra-arterial |
Data Type | Standards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
Description | Identifies the route of administration. For example: Apply Externally Buccal Dental Intravenous Oral Intra-arterial |
Data Type | Standards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
Description | The period of time that an action is delayed relative to an original schedule. Derived from comparing the dates of the scheduled activity with the corresponding performed activity. For example: If a substance administration is delayed 2 days as a result of an adverse event, then the delay duration is 2 days. |
Data Type | Standards - Data Domains.ddm/Data Domains/Quantity Integer [INTEGER] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
Description | Specifies how the notification message is to be delivered. For example: |
Data Type | Standards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
Description | Specifies how the notification message is to be delivered. For example: |
Data Type | Standards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
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 |
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 |
Description | A numeric surrogate key used to uniquely identify entities in the dimensional model. |
Data Type | Standards - Data Domains.ddm/Data Domains/Surrogate Key Large [LONG] |
Is Part Of PrimaryKey | false |
Is Required | true |
Is Derived | false |
Is Surrogate Key | false |
Description | A numeric surrogate key used to uniquely identify entities in the atomic model. |
Data Type | Standards - Data Domains.ddm/Data Domains/Surrogate Key Large [LONG] |
Is Part Of PrimaryKey | false |
Is Required | true |
Is Derived | false |
Is Surrogate Key | false |
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/Tenant Common Code [VARCHAR(80)] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
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/Surrogate Key [INTEGER] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
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 |
Description | The surrogate key of the load information entry describing the details regarding the loading of the row. |
Data Type | Standards - Data Domains.ddm/Data Domains/Surrogate Key Large [LONG] |
Is Part Of PrimaryKey | false |
Is Required | true |
Is Derived | false |
Is Surrogate Key | false |
Description | Establishes a period where a set of attributes are true according to the business. |
Data Type | Standards - Data Domains.ddm/Data Domains/Date [DATE] |
Is Part Of PrimaryKey | false |
Is Required | true |
Is Derived | false |
Is Surrogate Key | false |
Description | Ends a period of effectivity. |
Data Type | Standards - Data Domains.ddm/Data Domains/Date [DATE] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
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/Tenant Common Code [VARCHAR(80)] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
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/Surrogate Key [INTEGER] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
Description | A numeric surrogate key used to uniquely identify entities in the dimensional model. |
Data Type | Standards - Data Domains.ddm/Data Domains/Surrogate Key Large [LONG] |
Is Part Of PrimaryKey | false |
Is Required | true |
Is Derived | false |
Is Surrogate Key | false |
Description | A numeric surrogate key used to uniquely identify entities in the atomic model. |
Data Type | Standards - Data Domains.ddm/Data Domains/Surrogate Key Large [LONG] |
Is Part Of PrimaryKey | false |
Is Required | true |
Is Derived | false |
Is Surrogate Key | false |
Description | A numeric surrogate key used to uniquely identify entities in the dimensional model. |
Data Type | Standards - Data Domains.ddm/Data Domains/Surrogate Key Large [LONG] |
Is Part Of PrimaryKey | false |
Is Required | true |
Is Derived | false |
Is Surrogate Key | false |
Description | A numeric surrogate key used to uniquely identify entities in the atomic model. |
Data Type | Standards - Data Domains.ddm/Data Domains/Surrogate Key Large [LONG] |
Is Part Of PrimaryKey | false |
Is Required | true |
Is Derived | false |
Is Surrogate Key | false |
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 |
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 |
Description | Specifies whether the study subject gave official consent by signing the official consent form. |
Data Type | Standards - Data Domains.ddm/Data Domains/Boolean Indicator [INTEGER] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
Description | The date (and time) the study subject gives official consent by signing the official consent form. |
Data Type | Standards - Data Domains.ddm/Data Domains/Date Time [TIMESTAMP] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
Description | Specifies whether the planned activity is interruptible by asynchronous events. This may only be useful for Planned Subject Activity Groups or administrative activities. |
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 |
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 |
Description | Specifies the technique that is used to store the material. For example: Liquid nitrogen Vapor phase Electric freezer |
Data Type | Standards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
Description | Specifies the technique that is used to store the material. For example: Liquid nitrogen Vapor phase Electric freezer |
Data Type | Standards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
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 |
Description | Identifies 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 Type | Standards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
Description | Identifies 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 Type | Standards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
Description | A 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 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 | 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 |
Description | The text and/or code that describes why an activity did not occur. For example: Forgot to ask Sample lost |
Data Type | Standards - Data Domains.ddm/Data Domains/String [VARCHAR(255)] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
Description | A numeric surrogate key used to uniquely identify entities in the dimensional model. |
Data Type | Standards - Data Domains.ddm/Data Domains/Surrogate Key Large [LONG] |
Is Part Of PrimaryKey | false |
Is Required | true |
Is Derived | false |
Is Surrogate Key | false |
Description | A numeric surrogate key used to uniquely identify entities in the atomic model. |
Data Type | Standards - Data Domains.ddm/Data Domains/Surrogate Key Large [LONG] |
Is Part Of PrimaryKey | false |
Is Required | true |
Is Derived | false |
Is Surrogate Key | false |
Description | A numeric surrogate key used to uniquely identify entities in the dimensional model. |
Data Type | Standards - Data Domains.ddm/Data Domains/Surrogate Key Large [LONG] |
Is Part Of PrimaryKey | false |
Is Required | true |
Is Derived | false |
Is Surrogate Key | false |
Description | A numeric surrogate key used to uniquely identify entities in the atomic model. |
Data Type | Standards - Data Domains.ddm/Data Domains/Surrogate Key Large [LONG] |
Is Part Of PrimaryKey | false |
Is Required | true |
Is Derived | false |
Is Surrogate Key | false |
Description | A numeric surrogate key used to uniquely identify entities in the dimensional model. |
Data Type | Standards - Data Domains.ddm/Data Domains/Surrogate Key Large [LONG] |
Is Part Of PrimaryKey | false |
Is Required | true |
Is Derived | false |
Is Surrogate Key | false |
Description | A numeric surrogate key used to uniquely identify entities in the atomic model. |
Data Type | Standards - Data Domains.ddm/Data Domains/Surrogate Key Large [LONG] |
Is Part Of PrimaryKey | false |
Is Required | true |
Is Derived | false |
Is Surrogate Key | false |
Description | Specifies why the subject is removed from a study. For example: Patient died |
Data Type | Standards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
Description | Specifies why the subject is removed from a study. For example: Patient died |
Data Type | Standards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
Description | The date (and time) when the study subject is removed from the study. For example: The subject is not being followed and will not be retreated. |
Data Type | Standards - Data Domains.ddm/Data Domains/Date Time [TIMESTAMP] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
Description | The amount and unit of study agent transferred in original units. Original units can be derived from the translation attribute of the PQ data type Performed Study Agent Transfer Quantity. |
Data Type | Standards - Data Domains.ddm/Data Domains/Quantity Integer [INTEGER] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
Description | The subject of the notification. |
Data Type | Standards - Data Domains.ddm/Data Domains/Text Large [VARCHAR(1024)] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
Description | The actual text that was included in the notification. |
Data Type | Standards - Data Domains.ddm/Data Domains/Text Large [VARCHAR(1024)] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
Description | A numeric surrogate key used to uniquely identify entities in the dimensional model. |
Data Type | Standards - Data Domains.ddm/Data Domains/Surrogate Key Large [LONG] |
Is Part Of PrimaryKey | false |
Is Required | true |
Is Derived | false |
Is Surrogate Key | false |
Description | A numeric surrogate key used to uniquely identify entities in the atomic model. |
Data Type | Standards - Data Domains.ddm/Data Domains/Surrogate Key Large [LONG] |
Is Part Of PrimaryKey | false |
Is Required | true |
Is Derived | false |
Is Surrogate Key | false |
Description | A numeric surrogate key used to uniquely identify entities in the dimensional model. |
Data Type | Standards - Data Domains.ddm/Data Domains/Surrogate Key Large [LONG] |
Is Part Of PrimaryKey | false |
Is Required | true |
Is Derived | false |
Is Surrogate Key | false |
Description | A numeric surrogate key used to uniquely identify entities in the atomic model. |
Data Type | Standards - Data Domains.ddm/Data Domains/Surrogate Key Large [LONG] |
Is Part Of PrimaryKey | false |
Is Required | true |
Is Derived | false |
Is Surrogate Key | false |
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 |
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/Tenant Common Code [VARCHAR(80)] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
Description | The repeating frequency with which the treatment is to be administered. It is similar to the frequency and SIG code tables used in order entry systems. |
Data Type | Standards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
Description | A 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 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 |
Description | The 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 Type | Standards - Data Domains.ddm/Data Domains/Quantity Integer [INTEGER] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
Description | A numeric surrogate key used to uniquely identify entities in the dimensional model. |
Data Type | Standards - Data Domains.ddm/Data Domains/Surrogate Key Large [LONG] |
Is Part Of PrimaryKey | false |
Is Required | true |
Is Derived | false |
Is Surrogate Key | false |
Description | A numeric surrogate key used to uniquely identify entities in the atomic model. |
Data Type | Standards - Data Domains.ddm/Data Domains/Surrogate Key Large [LONG] |
Is Part Of PrimaryKey | false |
Is Required | true |
Is Derived | false |
Is Surrogate Key | false |
Description | A numeric surrogate key used to uniquely identify entities in the dimensional model. |
Data Type | Standards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER] |
Is Part Of PrimaryKey | false |
Is Required | true |
Is Derived | false |
Is Surrogate Key | false |
Description | A numeric surrogate key used to uniquely identify entities in the atomic model. |
Data Type | Standards - Data Domains.ddm/Data Domains/Surrogate Key Large [LONG] |
Is Part Of PrimaryKey | false |
Is Required | true |
Is Derived | false |
Is Surrogate Key | false |
Description | Specifies the technique that is used to transport the product. For example: Frozen gel pack Room temperature per transplant center request |
Data Type | Standards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
Description | Specifies the technique that is used to transport the product. For example: Frozen gel pack Room temperature per transplant center request |
Data Type | Standards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
Description | Specifies whether the time of the product transport is specified using standard (as opposed to daylight savings) time. If the location and date are known, this data is derivable. |
Data Type | Standards - Data Domains.ddm/Data Domains/Boolean Indicator [INTEGER] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
Description | A numeric surrogate key used to uniquely identify entities in the dimensional model. |
Data Type | Standards - Data Domains.ddm/Data Domains/Surrogate Key Large [LONG] |
Is Part Of PrimaryKey | false |
Is Required | true |
Is Derived | false |
Is Surrogate Key | false |
Description | A numeric surrogate key used to uniquely identify entities in the atomic model. |
Data Type | Standards - Data Domains.ddm/Data Domains/Surrogate Key Large [LONG] |
Is Part Of PrimaryKey | false |
Is Required | true |
Is Derived | false |
Is Surrogate Key | false |
Description | The 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 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 | 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/Tenant Common Code [VARCHAR(80)] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
Description | A coded value specifying the motivation, cause, or rationale of an activity. For example: Routine requirement Drug reaction Infectious disease reporting requirement On patient request |
Data Type | Standards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
Description | The date (and time) the subject has been registered to the study assuming they have finished screening and have been found eligible. |
Data Type | Standards - Data Domains.ddm/Data Domains/Date Time [TIMESTAMP] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
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/Tenant Common Code [VARCHAR(80)] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
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/Surrogate Key [INTEGER] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
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 |
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/Tenant Common Code [VARCHAR(80)] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
Description | The repeating frequency with which the treatment is to be administered. It is similar to the frequency and SIG code tables used in order entry systems. |
Data Type | Standards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
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 |
Description | An 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 Type | Standards - Data Domains.ddm/Data Domains/Quantity Integer [INTEGER] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
Description | An integer that identifies the particular occurrence of a repeating activity. The first repetition is defined as '1'. For example: A Planned Activity might have a repeat quantity of 4 which would result in 4 scheduled activities and performed activities with repetition numbers of 1, 2, 3, and 4 respectively. Derived from Scheduled ActivityRepetition Number. |
Data Type | Standards - Data Domains.ddm/Data Domains/Quantity Integer [INTEGER] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
Description | The 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 Type | Standards - Data Domains.ddm/Data Domains/Quantity Integer [INTEGER] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
Description | The expected end date of the scheduled activity. |
Data Type | Standards - Data Domains.ddm/Data Domains/Date [DATE] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
Description | The subject of the notification. |
Data Type | Standards - Data Domains.ddm/Data Domains/Text Large [VARCHAR(1024)] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
Description | The actual text scheduled to be included in the notification. This may mean that message variables have been replaced with actual data. |
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 | An integer that identifies the particular occurrence of a repeating activity. The first repetition is defined as '1'. For example: A Planned Activity might have a repeat quantity of 4 which would result in 4 scheduled activities with repetition numbers of 1, 2, 3, and 4 respectively. |
Data Type | Standards - Data Domains.ddm/Data Domains/Quantity Integer [INTEGER] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
Description | The expected start date of the scheduled activity. |
Data Type | Standards - Data Domains.ddm/Data Domains/Date [DATE] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
Description | The code that corresponds to the Source Code Sk. |
Data Type | Standards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)] |
Is Part Of PrimaryKey | false |
Is Required | true |
Is Derived | false |
Is Surrogate Key | false |
Description | The origin of the data identifying the actual load source, vendor, manual key entry, or context of the data in a specific row in the database. |
Data Type | Standards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER] |
Is Part Of PrimaryKey | false |
Is Required | true |
Is Derived | false |
Is Surrogate Key | false |
Description | A numeric surrogate key used to uniquely identify entities in the dimensional model. |
Data Type | Standards - Data Domains.ddm/Data Domains/Surrogate Key Large [LONG] |
Is Part Of PrimaryKey | false |
Is Required | true |
Is Derived | false |
Is Surrogate Key | false |
Description | A numeric surrogate key used to uniquely identify entities in the atomic model. |
Data Type | Standards - Data Domains.ddm/Data Domains/Surrogate Key Large [LONG] |
Is Part Of PrimaryKey | false |
Is Required | true |
Is Derived | false |
Is Surrogate Key | false |
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 |
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/Tenant Common Code [VARCHAR(80)] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
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/Surrogate Key [INTEGER] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
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/Tenant Common Code [VARCHAR(80)] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
Description | Specifies why the status has changed. |
Data Type | Standards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
Description | Specifies why the status has changed. |
Data Type | Standards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
Description | Indicates the phase in the lifecycle of the activity as part of a global library. For example: Draft New Released Retired Archived |
Data Type | Standards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
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 |
Description | An 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 Type | Standards - Data Domains.ddm/Data Domains/Percentage [FLOAT(2)] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
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 |
Description | A numeric surrogate key used to uniquely identify entities in the dimensional model. |
Data Type | Standards - Data Domains.ddm/Data Domains/Surrogate Key Large [LONG] |
Is Part Of PrimaryKey | false |
Is Required | true |
Is Derived | false |
Is Surrogate Key | false |
Description | Specifies 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 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 |
Description | A numeric surrogate key used to uniquely identify entities in the dimensional model. |
Data Type | Standards - Data Domains.ddm/Data Domains/Surrogate Key Large [LONG] |
Is Part Of PrimaryKey | false |
Is Required | true |
Is Derived | false |
Is Surrogate Key | false |
Description | A numeric surrogate key used to uniquely identify entities in the atomic model. |
Data Type | Standards - Data Domains.ddm/Data Domains/Surrogate Key Large [LONG] |
Is Part Of PrimaryKey | false |
Is Required | true |
Is Derived | false |
Is Surrogate Key | false |
Description | The date (and time) used to indicate the start of the study for a subject. |
Data Type | Standards - Data Domains.ddm/Data Domains/Date [DATE] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
Description | The date (and time) used to indicate the end of the study for a subject. |
Data Type | Standards - Data Domains.ddm/Data Domains/Date [DATE] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
Description | An 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 Type | Standards - Data Domains.ddm/Data Domains/Percentage [FLOAT(2)] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
Description | A numeric surrogate key used to uniquely identify entities in the dimensional model. |
Data Type | Standards - Data Domains.ddm/Data Domains/Surrogate Key Large [LONG] |
Is Part Of PrimaryKey | false |
Is Required | true |
Is Derived | false |
Is Surrogate Key | false |
Description | A numeric surrogate key used to uniquely identify entities in the atomic model. |
Data Type | Standards - Data Domains.ddm/Data Domains/Surrogate Key Large [LONG] |
Is Part Of PrimaryKey | false |
Is Required | true |
Is Derived | false |
Is Surrogate Key | false |
Description | A numeric surrogate key used to uniquely identify entities in the atomic model. |
Data Type | Standards - Data Domains.ddm/Data Domains/Surrogate Key Large [LONG] |
Is Part Of PrimaryKey | false |
Is Required | true |
Is Derived | false |
Is Surrogate Key | false |
Description | A numeric surrogate key used to uniquely identify entities in the dimensional model. |
Data Type | Standards - Data Domains.ddm/Data Domains/Surrogate Key Large [LONG] |
Is Part Of PrimaryKey | false |
Is Required | true |
Is Derived | false |
Is Surrogate Key | false |
Description | A numeric surrogate key used to uniquely identify entities in the atomic model. |
Data Type | Standards - Data Domains.ddm/Data Domains/Surrogate Key Large [LONG] |
Is Part Of PrimaryKey | false |
Is Required | true |
Is Derived | false |
Is Surrogate Key | false |
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/Tenant Common Code [VARCHAR(80)] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
Description | Specifies a subdivision within a larger category of activities. For example: Chemotherapy Radiotherapy Hormonal therapy Alternative therapy |
Data Type | Standards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
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 |
Description | Specifies 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 Type | Standards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
Description | Specifies 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 Type | Standards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
Description | Specifies the side of the body (or a paired organ) that is a target site for an observation. For example: Bilateral Left Right |
Data Type | Standards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
Description | Specifies the side of the body (or a paired organ) that is a target site for an observation. For example: Bilateral Left Right |
Data Type | Standards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
Description | The thermal reading at which the storage unit was set. For example: gt -80 degrees celsius -135 to -80 degrees celsius |
Data Type | Standards - Data Domains.ddm/Data Domains/Text Small [VARCHAR(50)] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
Description | The surrogate key of the entry identifying the legal owner of the data. |
Data Type | Standards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER] |
Is Part Of PrimaryKey | false |
Is Required | true |
Is Derived | false |
Is Surrogate Key | false |
Description | The amount and unit of study agent transferred in standard or canonical units. |
Data Type | Standards - Data Domains.ddm/Data Domains/Quantity Integer [INTEGER] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
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 |
Description | Establishes a period where a set of attributes are true in the source system. This would be populated with the transaction timestamp and would be used for the snapshot date. |
Data Type | Standards - Data Domains.ddm/Data Domains/Timestamp [TIMESTAMP] |
Is Part Of PrimaryKey | false |
Is Required | true |
Is Derived | false |
Is Surrogate Key | false |
Description | Ends a period of validity. |
Data Type | Standards - Data Domains.ddm/Data Domains/Timestamp [TIMESTAMP] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
Description | Describes why what occurred is different from what was expected. For example: Subject received early treatment because of vacation plans. |
Data Type | Standards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
Description | Describes why what occurred is different from what was expected. For example: Subject received early treatment because of vacation plans. |
Data Type | Standards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
Description | Specifies the kind of variance. For example: Early / late occurrence of an act Higher / lower amount transferred |
Data Type | Standards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
Description | Specifies the kind of variance. For example: Early / late occurrence of an act Higher / lower amount transferred |
Data Type | Standards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
Relationship Details |
Is Identifying Relationship | false |
Child Table | Activity Fact |
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 | Product Dimension |
Parent Multiplicity | ONE |
Parent Referential Integrity: On Delete | NONE |
Parent Referential Integrity: On Insert | NONE |
Parent Referential Integrity: On Update | NONE |
Is Identifying Relationship | false |
Child Table | Activity Fact |
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 | Experimental Unit Dimension |
Parent Multiplicity | ONE |
Parent Referential Integrity: On Delete | NONE |
Parent Referential Integrity: On Insert | NONE |
Parent Referential Integrity: On Update | NONE |
Is Identifying Relationship | false |
Child Table | Activity Fact |
Child Role Name | performing |
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 | Organization Dimension |
Parent Multiplicity | ONE |
Parent Referential Integrity: On Delete | NONE |
Parent Referential Integrity: On Insert | NONE |
Parent Referential Integrity: On Update | NONE |
Is Identifying Relationship | false |
Child Table | Activity Fact |
Child Role Name | notified |
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 | Practitioner Dimension |
Parent Multiplicity | ONE |
Parent Referential Integrity: On Delete | NONE |
Parent Referential Integrity: On Insert | NONE |
Parent Referential Integrity: On Update | NONE |
Is Identifying Relationship | false |
Child Table | Activity Fact |
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 | Point Of Care Location Dimension |
Parent Multiplicity | ONE |
Parent Referential Integrity: On Delete | NONE |
Parent Referential Integrity: On Insert | NONE |
Parent Referential Integrity: On Update | NONE |
Is Identifying Relationship | false |
Child Table | Activity Fact |
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 | Document Dimension |
Parent Multiplicity | ONE |
Parent Referential Integrity: On Delete | NONE |
Parent Referential Integrity: On Insert | NONE |
Parent Referential Integrity: On Update | NONE |
Is Identifying Relationship | false |
Child Table | Activity Fact |
Child Role Name | performing |
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 | Person Dimension |
Parent Multiplicity | ONE |
Parent Referential Integrity: On Delete | NONE |
Parent Referential Integrity: On Insert | NONE |
Parent Referential Integrity: On Update | NONE |
Is Identifying Relationship | false |
Child Table | Activity Fact |
Child Role Name | notified |
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 | Person Dimension |
Parent Multiplicity | ONE |
Parent Referential Integrity: On Delete | NONE |
Parent Referential Integrity: On Insert | NONE |
Parent Referential Integrity: On Update | NONE |
Is Identifying Relationship | false |
Child Table | Activity Fact |
Child Role Name | notified |
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 | Organization Dimension |
Parent Multiplicity | ONE |
Parent Referential Integrity: On Delete | NONE |
Parent Referential Integrity: On Insert | NONE |
Parent Referential Integrity: On Update | NONE |
Is Identifying Relationship | false |
Child Table | Activity Fact |
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 | Calendar Dimension |
Parent Multiplicity | ONE |
Parent Referential Integrity: On Delete | NONE |
Parent Referential Integrity: On Insert | NONE |
Parent Referential Integrity: On Update | NONE |
Is Identifying Relationship | false |
Child Table | Activity Fact |
Child Role Name | required by |
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 | Study Protocol Dimension |
Parent Multiplicity | ONE |
Parent Referential Integrity: On Delete | NONE |
Parent Referential Integrity: On Insert | NONE |
Parent Referential Integrity: On Update | NONE |
Is Identifying Relationship | false |
Child Table | Activity Fact |
Child Role Name | performed in |
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 | Protocol Arm Dimension |
Parent Multiplicity | ONE |
Parent Referential Integrity: On Delete | NONE |
Parent Referential Integrity: On Insert | NONE |
Parent Referential Integrity: On Update | NONE |
Is Identifying Relationship | false |
Child Table | Activity Fact |
Child Role Name | component of |
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 | Epoch Dimension |
Parent Multiplicity | ONE |
Parent Referential Integrity: On Delete | NONE |
Parent Referential Integrity: On Insert | NONE |
Parent Referential Integrity: On Update | NONE |
Is Identifying Relationship | false |
Child Table | Activity Fact |
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 | Study Dimension |
Parent Multiplicity | ONE |
Parent Referential Integrity: On Delete | NONE |
Parent Referential Integrity: On Insert | NONE |
Parent Referential Integrity: On Update | NONE |
Is Identifying Relationship | false |
Child Table | Activity Fact |
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 | Study Subject Dimension |
Parent Multiplicity | ONE |
Parent Referential Integrity: On Delete | NONE |
Parent Referential Integrity: On Insert | NONE |
Parent Referential Integrity: On Update | NONE |
Is Identifying Relationship | false |
Child Table | Activity Fact |
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 | Specimen Dimension |
Parent Multiplicity | ONE |
Parent Referential Integrity: On Delete | NONE |
Parent Referential Integrity: On Insert | NONE |
Parent Referential Integrity: On Update | NONE |
Is Identifying Relationship | false |
Child Table | Activity Fact |
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 | Study Site Dimension |
Parent Multiplicity | ONE |
Parent Referential Integrity: On Delete | NONE |
Parent Referential Integrity: On Insert | NONE |
Parent Referential Integrity: On Update | NONE |
Primary Key Details |
Key Attribute | Activity Fact Dk |
| Dimensional Warehouse Model Data Model |