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END_EFFECTIVE_DT_TM DATETIME N The date/time after which the row is no longer valid as active current data.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