| Oracle® Clinical Stable Interface Technical Reference Manual Release 5.0 E36999-01 |
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PDF · Mobi · ePub |
| Oracle® Clinical Stable Interface Technical Reference Manual Release 5.0 E36999-01 |
|
|
PDF · Mobi · ePub |
Oracle Clinical Release 4.6 introduced an enhanced DCI Book form that allows you to create rules that define the required decision points in a flexible study.
The following tables hold the rule definitions for enhanced DCI Books:
DCI_BOOK_RULES is the master table. DCI_BOOK_RULE_TGT_INTERVALS and DCI_BOOK_RULE_TGT_DCIS are child tables. However, DCI_BOOK_RULE_TGT_INTERVALS and DCI_BOOK_RULE_TGT_DCIS are mutually exclusive in their relationship to DCI_BOOK_RULES: For a given RULE_ID in DCI_BOOK_RULES, the child rows are either in DCI_BOOK_RULE_TGT_INTERVALS or DCI_BOOK_RULE_TGT_DCIS. Which one is present is determined by the value of RULE_TYPE in the DCI_BOOK_RULES table.
The following tables for Patient Positions also support flexible studies:
Each of these Patient Position tables has a foreign key to PATIENT_POSITIONS and to the object of the expectedness they track: PP_EXPECTED_INTERVALS to PLAN_INTERVAL_ID, PP_EXPECTED_CPES to CLIN_PLAN_EVE_ID, and PP_EXPECTED_DCIS to DCI_ID. The PP_EXPECTED_DCIS also has a foreign key to the Clinical Planned Event (CPE) because DCIs are expected at a CPE. There is a row in the tables if the object is expected and none if it is not expected — with the caveat that intervals and CPEs will have a row present even if they are not expected if the BYPASSED_FLAG field indicates that they have been skipped due to a Bypass To rule.
Note:
Tables that have test data counterparts are designated by a (T) at the end of the table's title. PP_EXPECTED_INTERVALS(T) therefore describes the production table PP_EXPECTED_INTERVALS and the test table PP_EXPECTED_INTERVALST.DCI Book rules are created within a DCI Book for a flexible study. Each rule has a set of trigger conditions and a set of target conditions. The target or targets of a rule are conditional and only become expected when the trigger conditions are met. The DCI_BOOK_RULES table contains the trigger conditions (the data definition and data value or values), for a rule. A trigger may be the existence of a particular received DCI at a Clinical Planned Event, or it may be as specific as a particular response to a question in a qualified DCI module at a Clinical Planned Event. A DCI Book rule applies for the selected DCI Trigger at every CPE(s) at which it exists in the DCI Book.
Interval rules specify the conditions for the CPEs in an entire study Interval (or Intervals) to be required. There are two different types of Interval rule; the Enable rule, which sets the DCI – CPE combinations within the Interval as expected, or the Bypass To rule, which also causes all DCI – CPE combinations after the CPE of the data entry point — including DCI-CPE in the rest of the current interval — up to the target Interval to be non-expected.
DCI rules specify the criteria for a DCI to be required There are two different types of DCI rule; the 'Enable Within CPE' type applies to the target DCI(s) only at the same CPE as defined in the Trigger, and the 'Enable Across CPEs' applies to the target DCI(s) whenever it is collected in the DCI Book.
The details of the targets for a DCI Book rule are found in either the DCI_BOOK_RULE_TGT_INTERVALS table or the DCI_BOOK_RULE_TGT_DCIS table.
DCI_BOOK_RULES Related tables and foreign keys
| Name of related table | Foreign key name in this table | Foreign key name in the related table |
|---|---|---|
| DCI_BOOKS | DCI_BOOK_ID | DCI_BOOK_ID |
| Column | Null? | Type | Column Description |
|---|---|---|---|
| RULE_ID | Not null | NUMBER(10) | The rule ID value. |
| DCI_BOOK_ID | Not null | NUMBER(10) | The ID of the DCI Book. |
| RULE_TYPE | Not null | VARCHAR2(20) | Specifies whether the rule triggers Intervals or DCIs. Values are INTERVAL or DCI. |
| RULE_TARGET_ACTION | Not null | VARCHAR2(20) | Specifies the rule subtype. For Interval rules, the subtypes are Enable and Bypass To. For DCI rules, the subtypes are Across CPEs and Within CPE. |
| TRIGGER_DCI_ID | Not null | NUMBER(10) | ID of the DCI containing the data evaluated by the rule |
| TRIGGER_DCM_ID | Null | NUMBER(10) | ID of the DCM within the trigger DCI containing the data evaluated by the rule. The special value of 0 indicates that simply the presence of the DCI with a status of Pass 1 Complete or higher causes the rule to evaluate to TRUE. |
| TRIGGER_DCM_MODULE_SN | Null | NUMBER(3) | A serial number indicating the order of the trigger DCM module within the parent DCI |
| TRIGGER_DCM_QUALIFIER | Null | VARCHAR2(80) | Value of the Qualifying Question that identifies the particular DCM within the trigger DCI. |
| TRIGGER_DCM_QG_ID | Null | NUMBER(10) | ID of the DCM Question Group within the trigger DCI/DCM containing the data evaluated by the rule. |
| TRIGGER_DCM_QUE_ID | Null | NUMBER(10) | ID of the DCM Question within the trigger DCI/DCM containing the data evaluated by the rule. |
| TRIGGER_VALUES | Null | VARCHAR2(2000) | List of the Response values which cause the rule to evaluate to TRUE. Delimited by the non-printing character with ASCII value 31. |
| CLINICAL_STUDY_ID | Not null | NUMBER(10) | The ID of the clinical study. |
| CREATED_BY | Not null | VARCHAR2(30) | The username of the person who created the DCI Book rule. |
| CREATION_TS | Not null | DATE | Creation Timestamp |
| MODIFIED_BY | Null | VARCHAR2(30) | User who last modified this DCI book rule. |
| MODIFICATION_TS | Null | DATE | The Modification Timestamp. |
| RULE_DESCRIPTION | Null | VARCHAR2(200) | Describes the rule's function for the end user. The description appears on the Interval and the DCI rule screens. |
This table contains the target Interval(s) for an Interval rule in a DCI Book. The target can be one or more Intervals in the Study schedule, or the pseudo value [Next Interval], which is used, for example, in a study design where patients continue on cycles of treatment until an end point is reached.
When the Interval rule trigger conditions are met, all CPEs in the target Interval(s) become expected. All DCIs collected at those CPEs also become expected, if they are not the target of a DCI rule. For a Bypass To Interval rule, all DCI – CPE combinations after the CPE at which the trigger DCI meets the trigger conditions, up to the expected target Interval also become Non-expected.
Primary Key RULE_ID, INTERVAL_ID
DCI_BOOK_RULE_TGT_INTERVALS Related tables and foreign keys
| Name of related table | Foreign key name in this table | Foreign key name in the related table |
|---|---|---|
| DCI_BOOK_RULES | RULE_ID | RULE_ID |
DCI_BOOK_RULE_TGT_INTERVALS Column Descriptions
| Column | Null? | Type | Column Description |
|---|---|---|---|
| RULE_ID | Not null | NUMBER(10) | The rule ID. |
| INTERVAL_ID | Not null | NUMBER(10) | The target interval ID. |
| DCI_BOOK_ID | Not null | NUMBER(10) | The ID of the DCI Book. |
| CLINICAL_STUDY_ID | Not null | NUMBER(10) | The ID of the clinical study. |
| CREATED_BY | Not null | VARCHAR2(30) | The username of the person who created the DCI Book target interval. |
| CREATION_TS | Not null | DATE | The creation timestamp. |
| MODIFIED_BY | Null | VARCHAR2(30) | User who last modified this DCI book rule target interval. |
| MODIFICATION_TS | Null | DATE | The modification timestamp. |
This table contains the DCI(s) which are defined as the target of a DCI rule in a DCI Book. All DCIs that are not the target of a DCI rule are expected if the Interval, and therefore the CPEs, in which they are defined is, or becomes, expected. In addition, if a DCI is the target of a DCI rule, the rule trigger conditions must also be met for the DCI to become expected.
DCI_BOOK_RULE_TGT_DCIS Related tables and foreign keys
| Name of related table | Foreign key name in this table | Foreign key name in the related table |
|---|---|---|
| DCI_BOOK_RULES | RULE_ID | RULE_ID |
DCI_BOOK_RULE_TGT_DCIS Column Descriptions
| Column | Null? | Type | Column Description |
|---|---|---|---|
| RULE_ID | Not null | NUMBER(10) | The rule ID. |
| DCI_ID | Not null | NUMBER(10) | The ID of the DCI to which the DCI module belongs. |
| DCI_BOOK_ID | Not null | NUMBER(10) | The ID of the DCI Book. |
| CLINICAL_STUDY_ID | Not null | NUMBER(10) | The ID of the clinical study. |
| CREATED_BY | Not null | VARCHAR2(30) | The username of the person who created the DCI Book rule target DCI. |
| CREATION_TS | Not null | DATE | The creation timestamp. |
| MODIFIED_BY | Null | VARCHAR2(30) | User who last modified this DCI book rule target DCI. |
| MODIFICATION_TS | Null | DATE | The modification timestamp. |
PP_EXPECTED_INTERVALS tracks the current expectedness of Intervals for a particular Patient. If the Interval is expected for the Patient, there is an entry in this table with the BYPASSED_FLAG = N. If the Interval is not expected for the Patient, there is either no row or the entry has the BYPASSED_FLAG = Y.
Primary Key PATIENT_POSITION_ID, PLAN_INTERVAL_ID
PP_EXPECTED_INTERVALS Related tables and foreign keys
| Name of related table | Foreign key name in this table | Foreign key name in the related table |
|---|---|---|
| PATIENT_POSITIONS | PATIENT_POSITION_ID | PATIENT_POSITION_ID |
PP_EXPECTED_INTERVALS Column Descriptions
| Column Name | Null? | Type | Column Description |
|---|---|---|---|
| CLINICAL_STUDY_ID | Not null | NUMBER(10) | The ID of the clinical study. |
| PATIENT_POSITION_ID | Not null | NUMBER(10) | Patient Position ID |
| PLAN_INTERVAL_ID | Not null | NUMBER(10) | Plan Interval ID |
| BYPASSED_FLAG | Null | VARCHAR2(1) | Indicates whether Interval has been bypassed by Bypass To Interval rule. Values are Y or N. |
The PP_EXPECTED_INTERVALS table is audited by the PP_EXPECTED_INTERVALS$JN journal table. See the Column Descriptions in the table below.
PP_EXPECTED_INTERVALS$JN Related tables and foreign keys
| Name of related table | Foreign key name in this table | Foreign key name in the related table |
|---|---|---|
| PATIENT_POSITIONS | PATIENT_POSITION_ID | PATIENT_POSITION_ID |
PP_EXPECTED_INTERVALS$JN Column Descriptions
| Column Name | Null? | Type | Column Description |
|---|---|---|---|
| JN_SN | Not null | NUMBER(10) | Journal Sequence. |
| JN_OPERATION | Not null | VARCHAR2(3) | Journal Operation INS, UPD or DEL |
| JN_ORACLE_USER | Not null | VARCHAR2(30) | Oracle User who modified the data. |
| JN_TIMESTAMP | Not null | DATE | Journal Timestamp. |
| CLINICAL_STUDY_ID | Not null | NUMBER(10) | The ID of the clinical study. |
| PATIENT_POSITION_ID | Not null | NUMBER(10) | Patient Position ID. |
| PLAN_INTERVAL_ID | Not null | NUMBER(10) | Plan Interval ID. |
| BYPASSED_FLAG | Null | VARCHAR2(1) | Bypassed Flag. |
PP_EXPECTED_CPES tracks the current expectedness of clinical planned events for a particular Patient. If the clinical planned event is expected for the Patient, there is an entry in this table with the BYPASSED_FLAG = N. If the clinical planned event is not expected for the Patient, there is either no row or the entry has the BYPASSED_FLAG = Y.
Primary Key PATIENT_POSITION_ID, CLIN_PLAN_EVE_ID
PP_EXPECTED_CPES Related tables and foreign keys
| Name of related table | Foreign key name in this table | Foreign key name in the related table |
|---|---|---|
| PATIENT_POSITIONS | PATIENT_POSITION_ID | PATIENT_POSITION_ID |
PP_EXPECTED_CPES Column Descriptions
| Column Name | Null? | Type | Column Description |
|---|---|---|---|
| CLINICAL_STUDY_ID | Not null | NUMBER(10) | The ID of the clinical study. |
| PATIENT_POSITION_ID | Not null | NUMBER(10) | Patient Position ID |
| CLIN_PLAN_EVE_ID | Not null | NUMBER(10) | Clinical planned event ID |
| BYPASSED_FLAG | Null | VARCHAR2 (1) | Indicates whether CPE has been bypassed by a Bypass To Interval rule. Values are Y or N. |
| LAST_EXPECTEDNESS_MOD_TS | Null | DATE | Timestamp of last modification of expectedness for a DCI assigned to this CPE in the DCI Book. It is updated whenever a DCI assigned to this CPE is added or removed from the PP_EXPECTED_DCIS table. |
The PP_EXPECTED_CPES table is audited by the PP_EXPECTED_CPES$JN journal table. See the Column Descriptions in the table below.
Related tables and foreign keys
| Name of related table | Foreign key name in this table | Foreign key name in the related table |
|---|---|---|
| PATIENT_POSITIONS | PATIENT_POSITION_ID | PATIENT_POSITION_ID |
PP_EXPECTED_CPES$JN Column Descriptions
| Column Name | Null? | Type | Column Description |
|---|---|---|---|
| JN_SN | Not null | NUMBER(10) | The Journal Sequence number. |
| JN_OPERATION | Not null | VARCHAR2(3) | Journal Operation INS, UPD, or DEL |
| JN_ORACLE_USER | Not null | VARCHAR2(30) | Oracle User who modified the data |
| JN_TIMESTAMP | Not Null | DATE | Journal Timestamp |
| CLINICAL_STUDY_ID | Not null | NUMBER(10) | The ID of the clinical study. |
| PATIENT_POSITION_ID | Not null | NUMBER(10) | Patient Position ID |
| CLIN_PLAN_EVE_ID | Not null | NUMBER(10) | Clinical planned event ID |
| BYPASSED_FLAG | Null | VARCHAR2(1) | Bypassed Flag |
| LAST_EXPECTEDNESS_MOD_TS | Null | DATE | Timestamp of last modification of expectedness for a DCI assigned to this CPE in the DCI Book. It is updated whenever a DCI assigned to this CPE is added or removed from the PP_EXPECTED_DCIS table. |
Note:
A journal row is not added if the only update is LAST_EXPECTEDNESS_MOD_TS.PP_EXPECTED_DCIS tracks the current expectedness of DCIs at Clinical Planned Events for a particular Patient. If the DCI is expected at a Clinical Planned Event for the Patient, there is an entry in this table. If the DCI is not expected, there is no entry.
Primary Key PATIENT_POSITION_ID, CLIN_PLAN_EVE_ID, DCI_ID
Related tables and foreign keys
| Name of related table | Foreign key name in this table | Foreign key name in the related table |
|---|---|---|
| PATIENT_POSITIONS | PATIENT_POSITION_ID | PATIENT_POSITION_ID |
PP_EXPECTED_DCIS Column Descriptions
| Column Name | Null? | Type | Column Description |
|---|---|---|---|
| CLINICAL_STUDY_ID | Not null | NUMBER(10) | The ID of the clinical study. |
| PATIENT_POSITION_ID | Not null | NUMBER(10) | Patient Position ID |
| CLIN_PLAN_EVE_ID | Not null | NUMBER)10) | Clinical planned event ID |
| DCI_ID | Not null | NUMBER(10) | The ID of the DCI to which the expected DCI belongs. |
| CREATION_TS | Not null | DATE | The creation timestamp. |
The PP_EXPECTED_DCIS table is audited by the PP_EXPECTED_DCIS$JN journal table. See the Column Descriptions in the table below.
Related tables and foreign keys
| Name of related table | Foreign key name in this table | Foreign key name in the related table |
|---|---|---|
| PATIENT_POSITIONS | PATIENT_POSITION_ID | PATIENT_POSITION_ID |
PP_EXPECTED_DCIS$JN Column Descriptions
| Column Name | Null? | Type | Column Description |
|---|---|---|---|
| JN_SN | Not null | NUMBER(10) | Journal Sequence |
| JN_OPERATION | Not null | VARCHAR2(3) | Journal Operation INS, UPD or DEL |
| JN_ORACLE_USER | Not null | VARCHAR2(30) | Oracle User who modified the data |
| JN_TIMESTAMP | Not null | DATE | The journal timestamp. |
| CLINICAL_STUDY_ID | Not null | NUMBER(10) | The ID of the clinical study. |
| PATIENT_POSITION_ID | Not null | NUMBER(10) | Patient Position ID |
| CLIN_PLAN_EVE_ID | Not null | NUMBER(10) | Clinical planned event ID |
| DCI_ID | Not null | NUMBER(10) | The ID of the DCI to which the expected DCI belongs. |
| CREATION_TS | Not null | DATE | The creation timestamp. |
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