Storage MethodTemperature Range TxtVariance ReasonVariance Type
| Business Data Model Data Model |
| Description | A performed activity that is completed within the context of a given study that is not directly related to the study's overarching hypothesis evaluation or testing, but is nonetheless essential to the efficient and effective coordination and execution of the study. For example: Assignment to a treatment arm Registration to a study Start of on-study period End of on-study period Obtain informed consent Verify eligibility criteria Enroll Randomize Complete study visits Exit study Break treatment blind Protocol violation Premature withdrawal |
| Attributes | |
| Storage Method |
|
| Temperature Range Txt |
|
| Variance Reason |
|
| Variance Type |
|
| Relationship | |
 Administrative Activity_Arm_FK |
|
| Administrative Activity_Study Site_FK |
|
| Administrative Activity_Document_FK |
|
| Generalization | |
 R_1618 |
|
| Dependencies | |
 NONE |
|
| Reverse Dependencies | |
| |
|
| Attribute Details |
Storage Method
| 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/Enumeration [VARCHAR(20)] |
| Is Part Of PrimaryKey | false |
| Is Required | false |
| Is Derived | false |
| Is Surrogate Key | false |
Temperature Range Txt
| 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 |
Variance Reason
| 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/Enumeration [VARCHAR(20)] |
| Is Part Of PrimaryKey | false |
| Is Required | false |
| Is Derived | false |
| Is Surrogate Key | false |
Variance Type
| 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/Enumeration [VARCHAR(20)] |
| Is Part Of PrimaryKey | false |
| Is Required | false |
| Is Derived | false |
| Is Surrogate Key | false |
| Relationship Details |
Administrative Activity_Arm_FK
| Is Identifying Relationship | false |
| Child Table | Administrative 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 | Arm |
| Parent Multiplicity | ZERO_TO_ONE |
| Parent Referential Integrity: On Delete | NONE |
| Parent Referential Integrity: On Insert | NONE |
| Parent Referential Integrity: On Update | NONE |
Administrative Activity_Study Site_FK
| Is Identifying Relationship | false |
| Child Table | Administrative 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 | Study Site |
| Parent Multiplicity | ONE |
| Parent Referential Integrity: On Delete | NONE |
| Parent Referential Integrity: On Insert | NONE |
| Parent Referential Integrity: On Update | NONE |
Administrative Activity_Document_FK
| Is Identifying Relationship | false |
| Child Table | Administrative 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 | Document |
| Parent Multiplicity | ONE |
| Parent Referential Integrity: On Delete | NONE |
| Parent Referential Integrity: On Insert | NONE |
| Parent Referential Integrity: On Update | NONE |
| Generalization Details |
R_1618
| Supertype | Performed Activity |
| Subtype | Administrative Activity |
| Transform As | TABLE |
| Business Data Model Data Model |