Table Detail Report
ELIG_QUEST_LIBRARY
Column Section | Relationship Section | Top of Page |
Table-level Detail
Description: | This table stores the library questions that are not related to an amendment. |
Definition: | This table contains library questions. These library questions can be imported to create specific amendment level questions. |
Table Type: | REFERENCE |
Column Detail - ELIG_QUEST_LIBRARY
Column Name | Type | Null? | Definition |
---|---|---|---|
ANSWER_FORMAT_ID | DOUBLE | N | The answer format that contains the valid answer for the question |
DATE_REQUIRED_FLAG | DOUBLE | N | Indicates if a date is required when answering this question |
ELIG_QUEST_LIBRARY_ID | DOUBLE | N | This is the value of the unique primary identifier of the elig_quest_library table. It is an internal system assigned number. |
EQL_CAT_CD | DOUBLE | N | Idneitifies which group this library question belongs to |
EQL_LABEL | VARCHAR(30) | N | A short display label for the question (< 30 characters) |
EQL_QUESTION | VARCHAR(2000) | N | *OBSOLETE - Question Text. Replaced by value associate with LONG_TEXT_ID from Long Text Reference |
LOGICAL_DOMAIN_ID | DOUBLE | N | The unique identifier for a logical domain. This identifier allows the data to be grouped by logical domain. For example, If you assign clients a logical_domain_id this would allow you to store data for multiple clients on this table. |
LONG_TEXT_ID | DOUBLE | N | References the Long Text for the eligible question. Foreign Key from Long Text Reference table. |
UPDT_APPLCTX | DOUBLE | N | The application context number from the record info block. The UPDT family of columns are typically used for housekeeping and external system process and should never be depended on for solution specific logic. |
UPDT_CNT | DOUBLE | N | Set to 0 on insert. Incremented by 1 on update. Used to recognize update conflict where data in a row updated by one application is at risk of being lost by a second application attempting to update the row. The UPDT family of columns are typically used for housekeeping and external system process and should never be depended on for solution specific logic. |
UPDT_DT_TM | DATETIME | N | The date and time the row was last inserted or updated. The UPDT family of columns are typically used for housekeeping and external system process and should never be depended on for solution specific logic. |
UPDT_ID | DOUBLE | N | The person_id of the person from the personnel table (prsnl) that caused the last insert or update of the row in the table. The UPDT family of columns are typically used for housekeeping and external system process and should never be depended on for solution specific logic. |
UPDT_TASK | DOUBLE | N | The registered (assigned) task number for the process that inserted or updated the row. The UPDT family of columns are typically used for housekeeping and external system process and should never be depended on for solution specific logic. |
VALUE_REQUIRED_FLAG | DOUBLE | N | Indicates if a value is required for the question. 0 indicates not required. 1 indicates required and 2 indicates optional |
Relationship Detail - ELIG_QUEST_LIBRARY
Child Column in ELIG_QUEST_LIBRARY(FK) | Parent Table Name | Parent Column Name | |
---|---|---|---|
Parents: | ANSWER_FORMAT_ID | ANSWER_FORMAT | ANSWER_FORMAT_ID |
LOGICAL_DOMAIN_ID | LOGICAL_DOMAIN | LOGICAL_DOMAIN_ID | |
LONG_TEXT_ID | LONG_TEXT_REFERENCE | LONG_TEXT_ID |
ENTITY_ACCESS
Column Section | Relationship Section | Top of Page |
Table-level Detail
Description: | Table stores the Access mask for entities. |
Definition: | Table stores the Access mask for entities. The access masks in this table over-ride the default access masks determined by the role played by the entity on the amendment |
Table Type: | REFERENCE |
Column Detail - ENTITY_ACCESS
Column Name | Type | Null? | Definition |
---|---|---|---|
ACCESS_MASK | CHAR(5) | N | A mask of characters to indicate the level of access - the mask could be made up of any or all of the following - R - Read C - Create U - Update D - Delete E - Execute |
BEG_EFFECTIVE_DT_TM | DATETIME | N | The date and time for which this table row becomes effective. Normally, this will be the date and time the row is added, but could be a past or future date and time. |
END_EFFECTIVE_DT_TM | DATETIME | Y | The date/time after which the row is no longer valid as active current data. This may be valued with the date that the row became inactive. |
ENTITY_ACCESS_ID | DOUBLE | N | Primary Key |
FUNCTIONALITY_CD | DOUBLE | N | The functionality for which the access mask is defined |
PERSON_ID | DOUBLE | N | This is the value of the unique primary identifier of the person table. It is an internal system assigned number. |
PROT_AMENDMENT_ID | DOUBLE | N | uniquely identifies the amendment |
UPDT_APPLCTX | DOUBLE | N | The application context number from the record info block. |
UPDT_CNT | DOUBLE | N | Set to 0 on insert. Incremented by 1 on update. Used to recognize update conflict where data in a row updated by one application is at risk of being lost by a second application attempting to update the row. |
UPDT_DT_TM | DATETIME | N | The date and time the row was last inserted or updated. |
UPDT_ID | DOUBLE | N | The person_id of the person from the personnel table (prsnl) that caused the last insert or update of the row in the table. |
UPDT_TASK | DOUBLE | N | The registered (assigned) task number for the process that inserted or updated the row. |
Relationship Detail - ENTITY_ACCESS
Child Column in ENTITY_ACCESS(FK) | Parent Table Name | Parent Column Name | |
---|---|---|---|
Parents: | PROT_AMENDMENT_ID | PROT_AMENDMENT | PROT_AMENDMENT_ID |
PERSON_ID | PRSNL | PERSON_ID |
IND_IDE_OWNERSHIP
Column Section | Relationship Section | Top of Page |
Table-level Detail
Description: | INVESTIGATIONAL NEW DRUG INVESTIGATIONAL DEVICE OWNERSHIP |
Definition: | This table stores ownership information on investigational new drug or device |
Table Type: | REFERENCE |
Column Detail - IND_IDE_OWNERSHIP
Column Name | Type | Null? | Definition |
---|---|---|---|
AGENT_DEV_ID | DOUBLE | N | This field identifies the investigational new drug or device whose ownership is being recorded. |
BEG_EFFECTIVE_DT_TM | DATETIME | N | The date and time for which this table row becomes effective. Normally, this will be the date and time the row is added, but could be a past or future date and time. |
END_EFFECTIVE_DT_TM | DATETIME | N | The date/time after which the row is no longer valid as active current data. This may be valued with the date that the row became inactive. |
IND_IDE_NBR | VARCHAR(6) | Y | The number of the IND/IDE |
IND_IDE_OWNERSHIP_ID | DOUBLE | N | Primary Key |
ORGANIZATION_ID | DOUBLE | N | Uniquely identifies the organization which owns the drug/device |
OWNERSHIP_ID | DOUBLE | N | A unique key for the Investigation Drug or Device's Owner on a protocol. No two active rows can have the same ownership_id. |
PERSON_ID | DOUBLE | N | This is the value of the unique primary identifier of the person table. It is an internal system assigned number. |
ROLE_TYPE_CD | DOUBLE | N | The role which owns the drug/device |
UPDT_APPLCTX | DOUBLE | N | The application context number from the record info block. |
UPDT_CNT | DOUBLE | N | Set to 0 on insert. Incremented by 1 on update. Used to recognize update conflict where data in a row updated by one application is at risk of being lost by a second application attempting to update the row. |
UPDT_DT_TM | DATETIME | N | The date and time the row was last inserted or updated. |
UPDT_ID | DOUBLE | N | The person_id of the person from the personnel table (prsnl) that caused the last insert or update of the row in the table. |
UPDT_TASK | DOUBLE | N | The registered (assigned) task number for the process that inserted or updated the row. |
VALID_FROM_DT_TM | DATETIME | N | The date from which IND/IDE is valid |
VALID_TO_DT_TM | DATETIME | N | The date till which IND/IDE is valid |
Relationship Detail - IND_IDE_OWNERSHIP
Child Column in IND_IDE_OWNERSHIP(FK) | Parent Table Name | Parent Column Name | |
---|---|---|---|
Parents: | OWNERSHIP_ID | IND_IDE_OWNERSHIP | IND_IDE_OWNERSHIP_ID |
ORGANIZATION_ID | ORGANIZATION | ORGANIZATION_ID | |
PERSON_ID | PRSNL | PERSON_ID |
Parent Column in IND_IDE_OWNERSHIP (PK) | Child Table Name | Child Column Name | |
---|---|---|---|
Children: | IND_IDE_OWNERSHIP_ID | IND_IDE_OWNERSHIP | OWNERSHIP_ID |
IND_IDE_TRACKING
Column Section | Top of Page |
Table-level Detail
Description: | this table is used to track drugs/devices |
Definition: | This table is used to track investigational new drug or device |
Table Type: | REFERENCE |
Column Detail - IND_IDE_TRACKING
Column Name | Type | Null? | Definition |
---|---|---|---|
AGENT_DEV_ID | DOUBLE | N | This field uniquely identifies a row in the invest_agent_dev table. |
BEG_EFFECTIVE_DT_TM | DATETIME | N | The date and time for which this table row becomes effective. Normally, this will be the date and time the row is added, but could be a past or future date and time. |
COMMENT_TXT | LONGBLOB | Y | This field contains any comments about the tracking that are deemed appropriate. |
END_EFFECTIVE_DT_TM | DATETIME | N | The date/time after which the row is no longer valid as active current data. This may be valued with the date that the row became inactive. |
IND_IDE_TRACKING_ID | DOUBLE | N | Primary Key |
TRACKING_CD | DOUBLE | N | This field contains a code indicating the type of tracking that was performed. |
TRACKING_DT_TM | DATETIME | N | This field contains the date and time on which the IND/IDE tracking was performed. |
UPDT_APPLCTX | DOUBLE | N | The application context number from the record info block. |
UPDT_CNT | DOUBLE | N | Set to 0 on insert. Incremented by 1 on update. Used to recognize update conflict where data in a row updated by one application is at risk of being lost by a second application attempting to update the row. |
UPDT_DT_TM | DOUBLE | N | The date and time the row was last inserted or updated. |
UPDT_ID | DOUBLE | N | The person_id of the person from the personnel table (prsnl) that caused the last insert or update of the row in the table. |
UPDT_TASK | DOUBLE | N | The registered (assigned) task number for the process that inserted or updated the row. |
INVEST_AGENT_DEV
Column Section | Relationship Section | Top of Page |
Table-level Detail
Description: | Contains info about investigational agents or devices being used in the protocol |
Definition: | This table contains information about investigational agents or devices being used in the protocol. |
Table Type: | REFERENCE |
Column Detail - INVEST_AGENT_DEV
Column Name | Type | Null? | Definition |
---|---|---|---|
AGENT_DEV_ID | DOUBLE | N | A logical identifier into the invest_agent_dev table. No two active rows (with end_effective_dt_tm of 31-dec-2100) will have the same agent_dev_id |
BEG_EFFECTIVE_DT_TM | DATETIME | N | The date and time for which this table row becomes effective. Normally, this will be the date and time the row is added, but could be a past or future date and time. |
END_EFFECTIVE_DT_TM | DATETIME | N | The date/time after which the row is no longer valid as active current data. This may be valued with the date that the row became inactive. |
INVEST_AGENT_DEV_CD | DOUBLE | N | This field contains a code indicating an investigational agent or device being used in the protocol/study. |
INVEST_AGENT_DEV_ID | DOUBLE | N | This is the value of the unique primary identifier of the invest_agent_dev table. It is an internal system assigned number. |
PROT_AMENDMENT_ID | DOUBLE | N | This field uniquely identifies a row in the prot_amendment table. This field identifies the protocol amendment that is using the investigational agent or device |
UPDT_APPLCTX | DOUBLE | N | The application context number from the record info block. |
UPDT_CNT | DOUBLE | N | Set to 0 on insert. Incremented by 1 on update. Used to recognize update conflict where data in a row updated by one application is at risk of being lost by a second application attempting to update the row. |
UPDT_DT_TM | DATETIME | N | The date and time the row was last inserted or updated. |
UPDT_ID | DOUBLE | N | The person_id of the person from the personnel table (prsnl) that caused the last insert or update of the row in the table. |
UPDT_TASK | DOUBLE | N | The registered (assigned) task number for the process that inserted or updated the row. |
Relationship Detail - INVEST_AGENT_DEV
Child Column in INVEST_AGENT_DEV(FK) | Parent Table Name | Parent Column Name | |
---|---|---|---|
Parents: | PROT_AMENDMENT_ID | PROT_AMENDMENT | PROT_AMENDMENT_ID |
Parent Column in INVEST_AGENT_DEV (PK) | Child Table Name | Child Column Name | |
---|---|---|---|
Children: | INVEST_AGENT_DEV_ID | INVEST_DEV | AGENT_DEV_ID |
INVEST_NEW_DRUG | AGENT_DEV_ID |