Informed Consent IndInformed Consent TsOff Study ReasonOff Study TsRegistration TsStudy Reference From TsStudy Reference To Ts
| Business Data Model Data Model |
| Description | An administrative activity that marks a common administrative landmark for a study subject in the course of a study. For example: Obtain informed consent Verify eligibility criteria Enroll Registration to a study Randomize Assignment to a treatment arm Start of on-study period Complete study visits End of on-study period Exit study Break treatment blind Premature withdrawal |
| Attributes | |
| Informed Consent Ind |
|
| Informed Consent Ts |
|
| Off Study Reason |
|
| Off Study Ts |
|
| Registration Ts |
|
| Study Reference From Ts |
|
| Study Reference To Ts |
|
| Relationship | |
 Study Subject Milestone_Study Subject_FK |
|
| Generalization | |
 R_1662 |
|
| Dependencies | |
 NONE |
|
| Reverse Dependencies | |
| |
|
| Attribute Details |
Informed Consent Ind
| 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 |
Informed Consent Ts
| 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 |
Off Study Reason
| Description | Specifies why the subject is removed from a study. For example: Patient died |
| 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 |
Off Study Ts
| 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 |
Registration Ts
| 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 |
Study Reference From Ts
| 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 |
Study Reference To Ts
| 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 |
| Relationship Details |
Study Subject Milestone_Study Subject_FK
| Is Identifying Relationship | false |
| Child Table | Study Subject Milestone |
| 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 |
| Parent Multiplicity | ZERO_TO_ONE |
| Parent Referential Integrity: On Delete | NONE |
| Parent Referential Integrity: On Insert | NONE |
| Parent Referential Integrity: On Update | NONE |
| Generalization Details |
R_1662
| Supertype | Administrative Activity |
| Subtype | Study Subject Milestone |
| Transform As | TABLE |
| Business Data Model Data Model |