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 | NUMBER | N | This field contains a code indicating whether accrual figures are required for this protocol |
| AMENDMENT_DESCRIPTION | VC2(255) | Y | This field contains a description of the amendment. |
| AMENDMENT_DT_TM | DATE | N | This field contains the date and time the amendment was approved. |
| AMENDMENT_NBR | NUMBER | N | This field contains the amendment sequence number (0 - initial protocol, 1 - first amendment, 2 - second amendment, 3 - third amendment, etc.). |
| AMENDMENT_STATUS_CD | NUMBER | N | Indicates the status of the amendment |
| ANTICIPATED_PROT_DURATION | NUMBER | 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 This column has been replaced by new column ANTICIPATED_PROT_DUR_VALUE in order to support decimal values.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 | NUMBER | 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 | FLOAT | 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 | VC2(255) | Y | Free text description of the compensation to be received by patients enrolled on the amendment |
| COMPENSATION_IND | NUMBER | N | An Indicator to specify if there is compensation connected to this amendment. |
| CT_DOMAIN_INFO_ID | NUMBER | N | The domain related to the amendment from the CT_DOMAIN_INFO table |
| DATA_CAPTURE_IND | NUMBER | N | Indicates if the amendment has data capture turned on or off. |
| DATA_SCRIPT_CD | NUMBER | N | The code value that points to the script that collects data for the protocol for integrate data capture. |
| DCV_AUTO_ENROLL_IND | NUMBER | N | This column indicates if the amendment has Discovere auto enrollment turned on or off. |
| ENROLL_STRATIFICATION_TYPE_CD | NUMBER | N | Indicates the stratification type of the amendment |
| GROUPWIDE_TARGETED_ACCRUAL | NUMBER | 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 | NUMBER | Y | Indicates if this protocol targets patients who are currently eligible for treatment on other open/planned protocols |
| PARENT_AMENDMENT_ID | NUMBER | N | The parent_amendment_id is the PK of the amendment a revision is for. |
| PARTICIPATION_TYPE_CD | NUMBER | N | Indicates the type of participation of the organizsation in the amendment. Examples include Institution only, cooperative group etc. |
| PROT_AMENDMENT_ID | NUMBER | N | Primary Key |
| PROT_MASTER_ID | NUMBER | N | Uniquely identifies the protocol to which this amendment is attached |
| PROT_TITLE | VC2(2000) | N | This field contains the title (name) of the protocol. |
| REVISION_IND | NUMBER | N | Indicates whether the amendment is a revision or not. |
| REVISION_NBR_TXT | VC2(30) | Y | Alphanumeric revision number for the revision. |
| REVISION_SEQ | NUMBER | N | Sequence the revision comes in after the amendment. |
| SAFETY_MONITOR_COMMITTEE_IND | NUMBER | Y | Indicator to specify if there is a safety committee connected to this amendment |
| TARGETED_ACCRUAL | NUMBER | 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 | NUMBER | N | The application context number from the record info block. |
| UPDT_CNT | NUMBER | 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 | DATE | N | The date and time the row was last inserted or updated. |
| UPDT_ID | NUMBER | 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 | NUMBER | 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 | NUMBER | N | This field contains the code for the protocol arm. |
| ARM_DESCRIPTION | VC2(255) | Y | This field contains a description of the protocol treatment arm. |
| ARM_STATUS_CD | NUMBER | 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 | NUMBER | 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 | DATE | Y | This field contains the date and time of the most recent suspension or closure of the protocol arm. |
| PRIMARY_REASON_CLOSURE_SUSP_CD | NUMBER | N | This field contains a code for the primary reason that the protocol arm was suspended or closed. |
| PROT_AMENDMENT_ID | NUMBER | 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 | NUMBER | N | This is the value of the unique primary identifier of the prot_arm table. It is an internal system assigned number. |
| TARGETED_ACCRUAL | NUMBER | Y | This field contains the targeted number of patients from the coordinating institution to be enrolled in the protocol arm. |
| UPDT_APPLCTX | NUMBER | N | The application context number from the record info block. |
| UPDT_CNT | NUMBER | 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 | DATE | N | The date and time the row was last inserted or updated. |
| UPDT_ID | NUMBER | 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 | NUMBER | 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 | DATE | 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 | NUMBER | 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 | VC2(30) | N | Display label for the cohort (Has to be less than 30 character in length) |
| COHORT_STATUS_CD | NUMBER | N | A code value indicating the status of the cohort. It can be Open, Closed or Suspended |
| END_EFFECTIVE_DT_TM | DATE | 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 | NUMBER | N | The link back to the cohort_id that this cohort originated or was copied from. |
| PROT_COHORT_DESCRIPTION | VC2(2000) | Y | Description of the cohort |
| PROT_COHORT_ID | NUMBER | N | This is the value of the unique primary identifier of the prot_cohort table. It is an internal system assigned number. |
| PT_ACCRUAL | NUMBER | Y | Number of patients to be accrued on the cohort |
| STATUS_CHG_REASON_CD | NUMBER | N | A code value indicating the reason for change in the status of cohort |
| STRATUM_ID | NUMBER | N | Identifies a row in the prot_stratum table. It identifies the stratum to which this cohort belongs. |
| UPDT_APPLCTX | NUMBER | N | The application context number from the record info block. |
| UPDT_CNT | NUMBER | 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 | DATE | N | The date and time the row was last inserted or updated. |
| UPDT_ID | NUMBER | 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 | NUMBER | N | The registered (assigned) task number for the process that inserted or updated the row. |
| VALID_FROM_DT_TM | DATE | N | The date on which the cohort becomes valid |
| VALID_TO_DT_TM | DATE | 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 | DATE | 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 | DATE | 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 | NUMBER | N | PRIMARY KEY |
| PROT_FILE_NAME | VC2(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 | NUMBER | N | Protocol File Type Flag: 1 = PROT1OCOL; 2 = ARM |
| PROT_KCW_LONG_BLOB_ID | NUMBER | N | The ID of the Retrieve Protocol for Execution(RPE) XML file stored on the long_blob table. |
| PROT_KCW_PROCESS_STATUS_IND | NUMBER | 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 | NUMBER | N | This field uniquely identifies a row in the PROT_MASTER table |
| PROT_POWER_PLAN_CMNT_TXT | VC2(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 | DATE | Y | The processing date of the power plan in knowledge compiler wizard. This value will be entered by the user. |
| PROT_POWER_PLAN_NAME | VC2(255) | Y | The name of the power plan. Entered by user. |
| PROT_POWER_PLAN_STATUS_IND | NUMBER | 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 | NUMBER | N | The count of updates that happened through web service requests |
| PROT_REQ_UPDATE_DT_TM | DATE | Y | The date on which the update occurred through a web service request. |
| PROT_RESEARCH_ACCOUNT_ID | NUMBER | N | The id of the Research Account that is linked with the protocol |
| PROT_RESEARCH_ACCOUNT_NAME | VC2(255) | Y | The research account of the organization which is billed for the ongoing study protocol. |
| PROT_RES_ACCNT_CD | NUMBER | N | represents the Research Account used for Clinical trials billing. (The code value from code set 4504006) |
| PROT_RPE_LONG_BLOB_ID | NUMBER | N | The ID of the Knowledge Compiler Wizard(KCW) XML file stored on the long_blob table. |
| UPDT_APPLCTX | NUMBER | 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 | NUMBER | 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 | DATE | 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 | NUMBER | 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 | NUMBER | Y | Indicates whether the update request was processed successfully |
| UPDT_TASK | NUMBER | 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 | DATE | 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 | DATE | 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 | VC2(100) | Y | The BILL MODIFIER code for the corresponding ORDER. |
| PROT_BILL_TO_TRIAL_CODE | VC2(100) | Y | The BILL TO TRIAL code for the corresponding ORDER. |
| PROT_CRPC_BILL_MODIFIER_ID | NUMBER | N | PRIMARY KEY |
| PROT_MASTER_ID | NUMBER | N | This field uniquely identifies a row in the PROT_MASTER table. |
| PROT_ORDER_CKI_NBR | FLOAT | N | The unique value which helps to identify the component for an ORDER in the Power Plan XML |
| PROT_ORDER_EXTN_TXT | VC2(140) | Y | The unique value to identify an ORDER inside a protocol. |
| PROT_ORDER_MNEMONIC | VC2(255) | Y | The name of the ORDER for a protocol. A protocol can contain multiple ORDER's. |
| UPDT_APPLCTX | NUMBER | 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 | NUMBER | 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 | DATE | 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 | NUMBER | 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 | NUMBER | 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 |