Table Detail Report
INVEST_DEV
| Column Section | Relationship Section | Top of Page |
Table-level Detail
| Description: | INVEST DEV |
| Definition: | Contains information about investigational device |
| Table Type: | REFERENCE |
Column Detail - INVEST_DEV
| Column Name | Type | Null? | Definition |
|---|---|---|---|
| AGENT_DEV_ID | DOUBLE | N | Uniquely identifies the agent |
| 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. |
| DEVICE_ID | DOUBLE | N | A unique key for the Investigation Device on a protocol. No two active rows can have the same Device_id. |
| DEVICE_NAME | VARCHAR(20) | Y | Free text name of the investigational device |
| DEVICE_TYPE_CD | DOUBLE | N | Classification of the device / Classification of investigational drug. |
| END_EFFECTIVE_DT_TM | DATETIME | N | The date/time after which the row is no longer valid as active current data.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_DEVICE_NBR_TXT | VARCHAR(12) | N | Textual investigational device number. |
| INVEST_DEV_ID | DOUBLE | N | Primary Key |
| 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_DEV
| Child Column in INVEST_DEV(FK) | Parent Table Name | Parent Column Name | |
|---|---|---|---|
| Parents: | AGENT_DEV_ID | INVEST_AGENT_DEV | INVEST_AGENT_DEV_ID |
| DEVICE_ID | INVEST_DEV | INVEST_DEV_ID |
| Parent Column in INVEST_DEV (PK) | Child Table Name | Child Column Name | |
|---|---|---|---|
| Children: | INVEST_DEV_ID | INVEST_DEV | DEVICE_ID |
INVEST_NEW_DRUG
| Column Section | Relationship Section | Top of Page |
Table-level Detail
| Description: | INVEST NEW DRUG |
| Definition: | Contains information about investigation new drug |
| Table Type: | REFERENCE |
Column Detail - INVEST_NEW_DRUG
| Column Name | Type | Null? | Definition |
|---|---|---|---|
| AGENT_DEV_ID | DOUBLE | N | Uniquely identifies the drug |
| 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. |
| CATALOG_CD | DOUBLE | N | Identifies the drug |
| 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_DRUG_NAME | VARCHAR(255) | N | Textual investigational drug name. |
| INVEST_DRUG_NBR_TXT | VARCHAR(12) | N | Textual investigational drug number. |
| INVEST_NEW_DRUG_DEV_ID | DOUBLE | N | Uniquely identifies the IND/IDE |
| NEW_DRUG_ID | DOUBLE | N | A unique key for the Investigation Drug on a protocol. No two active rows can have the same new_drug_id. |
| 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_NEW_DRUG
| Child Column in INVEST_NEW_DRUG(FK) | Parent Table Name | Parent Column Name | |
|---|---|---|---|
| Parents: | AGENT_DEV_ID | INVEST_AGENT_DEV | INVEST_AGENT_DEV_ID |
| NEW_DRUG_ID | INVEST_NEW_DRUG | INVEST_NEW_DRUG_DEV_ID |
| Parent Column in INVEST_NEW_DRUG (PK) | Child Table Name | Child Column Name | |
|---|---|---|---|
| Children: | INVEST_NEW_DRUG_DEV_ID | INVEST_NEW_DRUG | NEW_DRUG_ID |
PEER_REVIEWER
| Column Section | Relationship Section | Top of Page |
Table-level Detail
| Description: | PEER REVIEWER |
| Definition: | Contains information aboutt review, done on a protocol by anothether institution |
| Table Type: | REFERENCE |
Column Detail - PEER_REVIEWER
| Column Name | Type | Null? | Definition |
|---|---|---|---|
| ORGANIZATION_ID | DOUBLE | N | This field uniquely identifies a row in the organization table. This field identifies the institution performing the peer review. For this purpose, an institution can be another hospital, research institute, drug company, government agency, etc. |
| PEER_REVIEWER_ID | DOUBLE | N | This is the value of the unique primary identifier of the peer_reviewer table. It is an internal system assigned number. |
| PEER_REVIEWER_STATUS_CD | DOUBLE | N | This field contains the code that defines the status of the peer review. |
| PROT_MASTER_ID | DOUBLE | N | This field uniquely identifies a row in the prot_master table. This field identifies the protocol that is subject to peer review. |
| 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 - PEER_REVIEWER
| Child Column in PEER_REVIEWER(FK) | Parent Table Name | Parent Column Name | |
|---|---|---|---|
| Parents: | ORGANIZATION_ID | ORGANIZATION | ORGANIZATION_ID |
| PROT_MASTER_ID | PROT_MASTER | PROT_MASTER_ID |
PROT_ALIAS
| Column Section | Relationship Section | Top of Page |
Table-level Detail
| Description: | PROT ALIAS |
| Definition: | This table contains the aliases for a protocol |
| Table Type: | REFERENCE |
Column Detail - PROT_ALIAS
| Column Name | Type | Null? | Definition |
|---|---|---|---|
| ALIAS_ID | DOUBLE | N | A unique key for the Protocol alias on a protocol. No two active rows can have the same Alias_id. |
| ALIAS_POOL_CD | DOUBLE | N | Identifies the alias pool to which this protocol alias belongs |
| 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. |
| PROT_ALIAS | VARCHAR(255) | N | This field contains the protocol mnemonic/code assigned to the protocol by an institution associated with the protocol. |
| PROT_ALIAS_ID | DOUBLE | N | This is the value of the unique primary identifier of the prot_alias table. It is an internal system assigned number. |
| PROT_ALIAS_TYPE_CD | DOUBLE | N | This field contains the code for the type of alias this protocol alias represents. |
| PROT_MASTER_ID | DOUBLE | N | This field uniquely identifies a row in the prot_master table. This field identifies the protocol for which this protocol alias applies |
| 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 - PROT_ALIAS
| Child Column in PROT_ALIAS(FK) | Parent Table Name | Parent Column Name | |
|---|---|---|---|
| Parents: | ALIAS_ID | PROT_ALIAS | PROT_ALIAS_ID |
| PROT_MASTER_ID | PROT_MASTER | PROT_MASTER_ID |
| Parent Column in PROT_ALIAS (PK) | Child Table Name | Child Column Name | |
|---|---|---|---|
| Children: | PROT_ALIAS_ID | PROT_ALIAS | ALIAS_ID |
PROT_AMD_COMMITTEE_RELTN
| Column Section | Relationship Section | Top of Page |
Table-level Detail
| Description: | Protocol amendment and committee relationship table. |
| Definition: | This table contains the required committees for a particular amendment's activation. |
| Table Type: | REFERENCE |
Column Detail - PROT_AMD_COMMITTEE_RELTN
| Column Name | Type | Null? | Definition |
|---|---|---|---|
| ACTIVE_IND | DOUBLE | N | The table row is active or inactive. A row is generally active unless it is in an inactive state such as logically deleted, combined away, pending purge, etc. |
| COMMITTEE_ID | DOUBLE | N | This field uniquely identifies a row in the committee table. This field identifies the commitee that is related to the protocol amendment. |
| EDIT_IND | DOUBLE | N | This field indicates whether the validate_ind field can be edited. |
| PROT_AMD_COMMITTEE_ID | DOUBLE | N | This is the value of the unique primary identifier of the Prot_amd_committee_reltn 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 related to the committee. |
| 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. |
| VALIDATE_IND | DOUBLE | N | The relationship between committee and amendment is selected as needing validated for when a protocol amendment is activated. |
Relationship Detail - PROT_AMD_COMMITTEE_RELTN
| Child Column in PROT_AMD_COMMITTEE_RELTN(FK) | Parent Table Name | Parent Column Name | |
|---|---|---|---|
| Parents: | COMMITTEE_ID | COMMITTEE | COMMITTEE_ID |
| PROT_AMENDMENT_ID | PROT_AMENDMENT | PROT_AMENDMENT_ID |