Table Detail Report

PROT_AMENDMENT



Column Section Relationship Section Top of Page


Table-level Detail

Description: PROT AMENDMENT
Definition: This table contains information about all amendments to a protocol
Table Type: REFERENCE





Column Detail - PROT_AMENDMENT


Column Name Type Null? Definition
ACCRUAL_REQUIRED_INDC_CD DOUBLE N This field contains a code indicating whether accrual figures are required for this protocol
AMENDMENT_DESCRIPTION VARCHAR(255) Y This field contains a description of the amendment.
AMENDMENT_DT_TM DATETIME N This field contains the date and time the amendment was approved.
AMENDMENT_NBR DOUBLE N This field contains the amendment sequence number (0 - initial protocol, 1 - first amendment, 2 - second amendment, 3 - third amendment, etc.).
AMENDMENT_STATUS_CD DOUBLE N Indicates the status of the amendment
ANTICIPATED_PROT_DURATION DOUBLE N Obsolete. This column has been replaced by new column ANTICIPATED_PROT_DUR_VALUE in order to support decimal values.
ANTICIPATED_PROT_DUR_UOM_CD DOUBLE N This field contains the code for the time units in which the anticipated protocol duration is expressed. Normally, this code would represent years or months.
ANTICIPATED_PROT_DUR_VALUE DOUBLE N This column replaces ANTICIPATED_PROT_DURATION. This new column will be defined an an F8 datatype for CCL in order to allow for decimal values. This field contains the anticipated duration of the protocol. The old column will be obsoleted.
COMPENSATION_DESCRIPTION VARCHAR(255) Y Free text description of the compensation to be received by patients enrolled on the amendment
COMPENSATION_IND DOUBLE N An Indicator to specify if there is compensation connected to this amendment.
CT_DOMAIN_INFO_ID DOUBLE N The domain related to the amendment from the CT_DOMAIN_INFO table
DATA_CAPTURE_IND DOUBLE N Indicates if the amendment has data capture turned on or off.
DATA_SCRIPT_CD DOUBLE N The code value that points to the script that collects data for the protocol for integrate data capture.
DCV_AUTO_ENROLL_IND DOUBLE N This column indicates if the amendment has Discovere auto enrollment turned on or off.
ENROLL_STRATIFICATION_TYPE_CD DOUBLE N Indicates the stratification type of the amendment
GROUPWIDE_TARGETED_ACCRUAL DOUBLE Y This field contains the number of patients that the protocol would like to have enrolled in the protocol. This figure includes the enrollment from all collaborating groups.
OTHER_APPLICABLE_PROT_IND DOUBLE Y Indicates if this protocol targets patients who are currently eligible for treatment on other open/planned protocols
PARENT_AMENDMENT_ID DOUBLE N The parent_amendment_id is the PK of the amendment a revision is for.
PARTICIPATION_TYPE_CD DOUBLE N Indicates the type of participation of the organizsation in the amendment. Examples include Institution only, cooperative group etc.
PROT_AMENDMENT_ID DOUBLE N Primary Key
PROT_MASTER_ID DOUBLE N Uniquely identifies the protocol to which this amendment is attached
PROT_TITLE VARCHAR(2000) N This field contains the title (name) of the protocol.
REVISION_IND DOUBLE N Indicates whether the amendment is a revision or not.
REVISION_NBR_TXT VARCHAR(30) Y Alphanumeric revision number for the revision.
REVISION_SEQ DOUBLE N Sequence the revision comes in after the amendment.
SAFETY_MONITOR_COMMITTEE_IND DOUBLE Y Indicator to specify if there is a safety committee connected to this amendment
TARGETED_ACCRUAL DOUBLE Y This field contains the number of patients that the protocol would like to have enrolled in the protocol from the coordinating institution.
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_AMENDMENT


Child Column in PROT_AMENDMENT(FK) Parent Table Name Parent Column Name
Parents: CT_DOMAIN_INFO_ID CT_DOMAIN_INFO CT_DOMAIN_INFO_ID
PARENT_AMENDMENT_ID PROT_AMENDMENT PROT_AMENDMENT_ID
PROT_MASTER_ID PROT_MASTER PROT_MASTER_ID




Parent Column in PROT_AMENDMENT (PK) Child Table Name Child Column Name
Children: PROT_AMENDMENT_ID AMENDMENT_REASON PROT_AMENDMENT_ID
APPL_DISEASE PROT_AMENDMENT_ID
CT_DOCUMENT PROT_AMENDMENT_ID
CT_MILESTONES PROT_AMENDMENT_ID
CT_PROT_AMD_CUSTOM_FLD_VAL PROT_AMENDMENT_ID
CT_PT_AMD_ASSIGNMENT PROT_AMENDMENT_ID
CT_PT_AMD_ASSIGNMENT TRANSFER_CHECKED_AMENDMENT_ID
DATA_SUBMISSION PROT_AMENDMENT_ID
ENTITY_ACCESS PROT_AMENDMENT_ID
INVEST_AGENT_DEV PROT_AMENDMENT_ID
PROT_AMD_COMMITTEE_RELTN PROT_AMENDMENT_ID
PROT_AMENDMENT PARENT_AMENDMENT_ID
PROT_ARM PROT_AMENDMENT_ID
PROT_ELIG_QUEST PROT_AMENDMENT_ID
PROT_GRANT_SPONSOR PROT_AMENDMENT_ID
PROT_MODALITY PROT_AMENDMENT_ID
PROT_OBJECTIVE PROT_AMENDMENT_ID
PROT_QUESTIONNAIRE PROT_AMENDMENT_ID
PROT_ROLE PROT_AMENDMENT_ID
PROT_STRATUM PROT_AMENDMENT_ID
PROT_SUSPENSION PROT_AMENDMENT_ID
PT_CONSENT PROT_AMENDMENT_ID
PT_ELIG_RESULT PROT_AMENDMENT_ID
PT_ELIG_TRACKING PROT_AMENDMENT_ID
REVISION PROT_AMENDMENT_ID
SAFETY_COMMITTEE PROT_AMENDMENT_ID


PROT_ARM



Column Section Relationship Section Top of Page


Table-level Detail

Description: PROT ARM
Definition: This table stores treatment arm information for an amendment
Table Type: REFERENCE





Column Detail - PROT_ARM


Column Name Type Null? Definition
ARM_CD DOUBLE N This field contains the code for the protocol arm.
ARM_DESCRIPTION VARCHAR(255) Y This field contains a description of the protocol treatment arm.
ARM_STATUS_CD DOUBLE N This field contains a code indicating the status of the protocol arm. The statii include, but are not limited to, open, suspended, closed and terminated
GROUPWIDE_TARGETED_ACCRUAL DOUBLE Y This field contains the targeted accrual for this protocol arm from all institutions enrolling patients in the protocol.
MOST_RECENT_CLOSURE_SUSP_DT_TM DATETIME Y This field contains the date and time of the most recent suspension or closure of the protocol arm.
PRIMARY_REASON_CLOSURE_SUSP_CD DOUBLE N This field contains a code for the primary reason that the protocol arm was suspended or closed.
PROT_AMENDMENT_ID DOUBLE N This field uniquely identifies a row in the prot_amendment table. This field identifies the protocol amendment for which this treatment arm is defined.
PROT_ARM_ID DOUBLE N This is the value of the unique primary identifier of the prot_arm table. It is an internal system assigned number.
TARGETED_ACCRUAL DOUBLE Y This field contains the targeted number of patients from the coordinating institution to be enrolled in the protocol arm.
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_ARM


Child Column in PROT_ARM(FK) Parent Table Name Parent Column Name
Parents: PROT_AMENDMENT_ID PROT_AMENDMENT PROT_AMENDMENT_ID




Parent Column in PROT_ARM (PK) Child Table Name Child Column Name
Children: PROT_ARM_ID PT_PROT_REG PROT_ARM_ID


PROT_COHORT



Column Section Relationship Section Top of Page


Table-level Detail

Description: PROT COHORT
Definition: This table contains information about the cohorts of a stratum
Table Type: REFERENCE





Column Detail - PROT_COHORT


Column Name Type Null? Definition
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.
COHORT_ID DOUBLE N Logical identifier into the prot_cohort table. No two active rows (End_effective_dt_tm = 31-dec-2100) will have the same cohort_id
COHORT_LABEL VARCHAR(30) N Display label for the cohort (Has to be less than 30 character in length)
COHORT_STATUS_CD DOUBLE N A code value indicating the status of the cohort. It can be Open, Closed or Suspended
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.
PARENT_COHORT_ID DOUBLE N The link back to the cohort_id that this cohort originated or was copied from.
PROT_COHORT_DESCRIPTION VARCHAR(2000) Y Description of the cohort
PROT_COHORT_ID DOUBLE N This is the value of the unique primary identifier of the prot_cohort table. It is an internal system assigned number.
PT_ACCRUAL DOUBLE Y Number of patients to be accrued on the cohort
STATUS_CHG_REASON_CD DOUBLE N A code value indicating the reason for change in the status of cohort
STRATUM_ID DOUBLE N Identifies a row in the prot_stratum table. It identifies the stratum to which this cohort belongs.
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 on which the cohort becomes valid
VALID_TO_DT_TM DATETIME N The date till which the cohort is valid. It can't accrue patients after this date.



Relationship Detail - PROT_COHORT


Child Column in PROT_COHORT(FK) Parent Table Name Parent Column Name
Parents: PARENT_COHORT_ID PROT_COHORT PROT_COHORT_ID




Parent Column in PROT_COHORT (PK) Child Table Name Child Column Name
Children: PROT_COHORT_ID PROT_COHORT PARENT_COHORT_ID


PROT_CRPC_BILLING



Column Section Relationship Section Top of Page


Table-level Detail

Description: PROTOCOL CLINICAL RESEARCH PROCESS CONTENT BILLING
Definition: Information on the XML files generated for Clinical Research Process Content and Knowledge Compiler Wizard.
Table Type: ACTIVITY





Column Detail - PROT_CRPC_BILLING


Column Name Type Null? Definition
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_CRPC_BILLING_ID DOUBLE N PRIMARY KEY
PROT_FILE_NAME VARCHAR(200) N The name of the file. For protocol's it will be the protocol title and for arm's it will be a combination of protocol title and arm title.
PROT_FILE_TYPE_FLAG DOUBLE N Protocol File Type Flag: 1 = PROT1OCOL; 2 = ARM
PROT_KCW_LONG_BLOB_ID DOUBLE N The ID of the Retrieve Protocol for Execution(RPE) XML file stored on the long_blob table.
PROT_KCW_PROCESS_STATUS_IND DOUBLE N The Success/Failure indicator to represent the status of the incoming Clinical Research Process Content(CRPC) request to Knowledge Compiler Wizard(KCW) compatible XML conversion.
PROT_MASTER_ID DOUBLE N This field uniquely identifies a row in the PROT_MASTER table
PROT_POWER_PLAN_CMNT_TXT VARCHAR(2000) Y The comments user adds pertaining to the power plan that is being processed in the knowledge compiler wizard.
PROT_POWER_PLAN_DT_TM DATETIME Y The processing date of the power plan in knowledge compiler wizard. This value will be entered by the user.
PROT_POWER_PLAN_NAME VARCHAR(255) Y The name of the power plan. Entered by user.
PROT_POWER_PLAN_STATUS_IND DOUBLE Y The processing status indicator of the power plan. Selected by user after processing power plan in knowledge compiler wizard. This is not a boolean field, as the name might imply, but can contain multiple values. Valid values are: 0=not assigned, 1=Production, 2=Testing, 3=Archive, 4=Inactive
PROT_REQ_UPDATE_CNT DOUBLE N The count of updates that happened through web service requests
PROT_REQ_UPDATE_DT_TM DATETIME Y The date on which the update occurred through a web service request.
PROT_RESEARCH_ACCOUNT_ID DOUBLE N The id of the Research Account that is linked with the protocol
PROT_RESEARCH_ACCOUNT_NAME VARCHAR(255) Y The research account of the organization which is billed for the ongoing study protocol.
PROT_RES_ACCNT_CD DOUBLE N represents the Research Account used for Clinical trials billing. (The code value from code set 4504006)
PROT_RPE_LONG_BLOB_ID DOUBLE N The ID of the Knowledge Compiler Wizard(KCW) XML file stored on the long_blob 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_STATUS_IND DOUBLE Y Indicates whether the update request was processed successfully
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.



Relationship Detail - PROT_CRPC_BILLING


Child Column in PROT_CRPC_BILLING(FK) Parent Table Name Parent Column Name
Parents: PROT_RES_ACCNT_CD CODE_VALUE CODE_VALUE
PROT_KCW_LONG_BLOB_ID LONG_BLOB LONG_BLOB_ID
PROT_RPE_LONG_BLOB_ID LONG_BLOB LONG_BLOB_ID
PROT_MASTER_ID PROT_MASTER PROT_MASTER_ID
PROT_RESEARCH_ACCOUNT_ID RESEARCH_ACCOUNT RESEARCH_ACCOUNT_ID


PROT_CRPC_BILL_MODIFIER



Column Section Relationship Section Top of Page


Table-level Detail

Description: PROTOCOL CLINICAL RESEARCH PROCESS CONTENT BILL MODIFIER
Definition: This table is used to store the bill modifier information for the orders that are part of a protocol
Table Type: ACTIVITY





Column Detail - PROT_CRPC_BILL_MODIFIER


Column Name Type Null? Definition
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_BILL_MODIFIER_CODE VARCHAR(100) Y The BILL MODIFIER code for the corresponding ORDER.
PROT_BILL_TO_TRIAL_CODE VARCHAR(100) Y The BILL TO TRIAL code for the corresponding ORDER.
PROT_CRPC_BILL_MODIFIER_ID DOUBLE N PRIMARY KEY
PROT_MASTER_ID DOUBLE N This field uniquely identifies a row in the PROT_MASTER table.
PROT_ORDER_CKI_NBR DOUBLE N The unique value which helps to identify the component for an ORDER in the Power Plan XML
PROT_ORDER_EXTN_TXT VARCHAR(140) Y The unique value to identify an ORDER inside a protocol.
PROT_ORDER_MNEMONIC VARCHAR(255) Y The name of the ORDER for a protocol. A protocol can contain multiple ORDER's.
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.



Relationship Detail - PROT_CRPC_BILL_MODIFIER


Child Column in PROT_CRPC_BILL_MODIFIER(FK) Parent Table Name Parent Column Name
Parents: PROT_MASTER_ID PROT_MASTER PROT_MASTER_ID