Agent Administration Care Setting TypeBlinded DescrInterruptible IndPurpose TxtRepeat FrequencyRepeat Frequency RatioRepeat Quantity RangeStudy Day Range QtyStudy Focus Ind
| Business Data Model Data Model |
| Description | An activity that is intended to occur or start at some point in the context of a particular study. For example: Pregnancy tests are planned for study subjects who are females of childbearing potential. |
| Attributes | |
| Agent Administration Care Setting Type |
|
| Blinded Descr |
|
| Interruptible Ind |
|
| Purpose Txt |
|
| Repeat Frequency |
|
| Repeat Frequency Ratio |
|
| Repeat Quantity Range |
|
| Study Day Range Qty |
|
| Study Focus Ind |
|
| Relationship | |
 containedPlannedActivity/1 |
|
| containedPlannedActivity |
|
| Generalization | |
 R_1295 |
|
| Dependencies | |
 NONE |
|
| Reverse Dependencies | |
| |
|
| Attribute Details |
Agent Administration Care Setting Type
| 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/Enumeration [VARCHAR(20)] |
| Is Part Of PrimaryKey | false |
| Is Required | false |
| Is Derived | false |
| Is Surrogate Key | false |
Blinded Descr
| 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 |
Interruptible Ind
| 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 |
Purpose Txt
| 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 |
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 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 |
Repeat Quantity Range
| 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 |
Study Day Range Qty
| 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 |
Study Focus Ind
| 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 |
| Relationship Details |
containedPlannedActivity/1
| Description | |
| Is Identifying Relationship | false |
| Child Table | Planned 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 | containedPlannedActivity |
| 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 |
containedPlannedActivity
| Description | |
| Is Identifying Relationship | false |
| Child Table | Planned Activity |
| Child Role Name | containingArm |
| 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 | Arm |
| Parent Role Name | containedPlannedActivity |
| Parent Multiplicity | ZERO_TO_MANY |
| Parent Referential Integrity: On Delete | NONE |
| Parent Referential Integrity: On Insert | NONE |
| Parent Referential Integrity: On Update | NONE |
| Generalization Details |
R_1295
| Supertype | Activity |
| Subtype | Planned Activity |
| Transform As | TABLE |
| Business Data Model Data Model |