Deviation CategoryOccurrence Date Range QtyProtocol Deviation SubcategorySeverity
| Business Data Model Data Model |
| Description | A performed observation result that designates an event as a variation from process or procedures defined in a study protocol. For example: Study subject not withdrawn as per protocol Excluded concomitant medication Treatment deviation Deviations usually do not preclude the overall evaluability of subject data for either efficacy or safety. |
| Attributes | |
| Deviation Category |
|
| Occurrence Date Range Qty |
|
| Protocol Deviation Subcategory |
|
| Severity |
|
| Relationship | |
 authorizedPerformedProtocolDeviation |
|
| Generalization | |
 R_1654 |
|
| Dependencies | |
 NONE |
|
| Reverse Dependencies | |
| |
|
| Attribute Details |
Deviation Category
| Description | Classification of protocol deviation. For example: Concomitant Medications Data Integrity Compromised Eligibility not checked Eligibility waiver Informed Consent Other specify Study Procedures Treatment [NCI CRF Standard examples] |
| 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 |
Occurrence Date Range Qty
| Description | The date and time span specifying when the protocol deviation began and ended. |
| 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 |
Protocol Deviation Subcategory
| Description | Specifies a subdivision within a larger category of a protocol deviation. |
| 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 |
Severity
| Description | Specifies the intensity of an activity, event or condition. For example: Major Moderate Minor |
| 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 |
authorizedPerformedProtocolDeviation
| Description | |
| Is Identifying Relationship | false |
| Child Table | Performed Protocol Deviation |
| Child Role Name | authorizingStudyLegalSponsor |
| 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 | Study Legal Sponsor |
| Parent Role Name | authorizedPerformedProtocolDeviation |
| 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 |
| Generalization Details |
R_1654
| Supertype | Performed Observation Result |
| Subtype | Performed Protocol Deviation |
| Transform As | TABLE |
| Business Data Model Data Model |