Study Codelist dataset
You can use the Study Codelist dataset in Oracle Clinical One Analytics to analyze and visualize data regarding codelists at both study and global level, as well as current code configurations and changes made over time.
Modes
This dataset displays design details of a study version available in any mode.
Roles that can run the report
Any user that's assigned the Run the Analytics Study Codelist Dataset permission can generate this report.
Global level codelists data is only available to global users assigned with the Code List Manager or the Oracle Admin roles.
Note:
Datasets in Oracle Clinical One Analytics display the data that you are allowed to view or edit based on defined data classifications.What type of data can I include in a custom report or visualization on study codelists?
The Study Codelist dataset can include detailed information about codes configured at study level. For instance, you can do the following:
- View all codelists available for your organization.
- View all available codelist items in multi-select questions, instead of just selected choices.
- Reference the study codelist dictionary when reviewing clinical data extracts.
- Review updates made to a codelist at the study level.
- Review updates made to code configuration at the global level.
For information about permissions required to access this dataset, see About your access to Oracle Clinical One Analytics.
Note:
Blank columns in Oracle Clinical One Analytics indicatenull or not applicable.
Parent topic: Dataset descriptions
Study folder
This table describes the data elements included in the Study folder
Table 2-37 Data elements in the Study folder
| Data element | Description |
|---|---|
| STUDY_MODE | Indicates the study mode used in the referencing data in a custom report, such as Testing, Training, or Active. |
| STUDY_ID_NAME | A study ID as specified by the study manager when they created the study, such as a protocol acronym and protocol number. |
| STUDY_TITLE | A protocol's title as specified by the study manager. |
| STUDY_REFNAME | Indicates the study's reference name used by the system. This value is composed by the STUDY_ID_NAME converted to uppercase with blank spaces removed. Once created, this value never changes, even if STUDY_ID_NAME is changed. |
| STUDY_PHASE | A study's phase as indicated by the study manager when they created the study. |
| THERAPEUTIC_AREA | Indicates the therapeutic area as specified by the study manager when they created the study. |
| BLINDING_TYPE | Indicates whether the study is an open-label type of study or a blinded study, as specified by the study manager when they created the study. |
| STUDY_VERSION | Indicates the study version number of the referencing data in a custom report. |
|
STUDY_DESIGN_STATUS |
Indicates the study mode used in the referencing data in a custom report, such as Testing, Training, or Active. |
Parent topic: Study Codelist dataset
Codelists folder
This table describes the data elements included in the Codelists folder.
| Data element | Description |
|---|---|
| CODE | Custom defined identifier for a code in Oracle Clinical One Platform. |
| CODE_DESCRIPTION | The description of the code record. |
| CODE_GROUP_NAME | Name that identifies the code group. |
| CODE_LABEL | Full code name that gets displayed. |
| CODE_LEVEL | Describes whether the record is at a system or custom level codelist. |
| CODE_NAME | The name of the codelist. |
| CODE_VALUE | The code value. |
| COMMENTS | Comment for record change. |
| DH_CODELIST_LEVEL | Describes whether it is an item, study or tenant codelist. |
| LOCALE | Code locale. English, Chinese and Japanese languages are supported. |
| REASON | User provided reason for record change. |
| SEQUENCE | Corresponds to the order assigned to a code in a codelist. This determines the order in which the codes in a codelist get listed. |
| DISPLAY_CODE_NAME | Name that appears in a dropdown when a codelist is used. |
| TAG | User defined tag for the code. |
| CL_HIDDEN | Denotes if a code is hidden to end users. |
Parent topic: Study Codelist dataset
Event folder
This table describes the data elements included in the event folder.
Table 2-38 Data elements in the event folder
| Data element | Description |
|---|---|
| EVENT_ID_NAME | The event's id as in Oracle Clinical One Platform. |
| EVENT_REFNAME |
The event's reference name. Displays a capitalized version of the (user entered) EVENT_TITLE with blank spaces removed. Oracle Clinical One Analytics generates this value, which is not displayed in the Oracle Clinical One Platform user interface. Note: This value does not change if the associated EVENT_TITLE is updated in a subsequent Study Version. |
| EVENT_TITLE | The event's title, defined by the user when an event is created. |
| EVENT_TYPE |
Displays the type of event that primarly impacts a visit's
status. Upon selecting this data element, only events that
occurred in your study are displayed. For example, you may see
some of the following events:
|
| IS_SCHEDULED_VISIT | Indicates if the visit is scheduled. |
| VISIT_CREATION_ORDER | Numeric visit order that follows the visit schedule as it was created. |
| VISIT_HOUR_SEQ_ORDER | The order in which subject visits occur, as configured in the study design. |
| VISIT_IS_REQUIRED | Indicates if a visit is required. |
| VISIT_TYPE | Displays the type of visit: Screening, Randomization, Dispensation, Non-Dispensation, Optional, Withdrawal or Study Completion. |
| VISIT_WINDOW_AFTER_DAYS | Indicates how many days after the scheduled date and time the visit can occur. |
| VISIT_WINDOW_AFTER_HOURS | Indicates how many hours after the scheduled date and time the visit can occur. |
| VISIT_WINDOW_BEFORE_DAYS | Indicates how many days before the scheduled date and time the visit can occur, as entered by a study designer. |
| VISIT_WINDOW_BEFORE_HOURS | Indicates how many hours before the scheduled date and time the visit can occur, as entered by a study designer. |
| SCHEDULED_FROM_EVENT_NAME |
Displays the EVENT_TITLE (visit title) of the Scheduled From visit as defined in the Visit Schedule. Note: If a visit is not scheduled or it is the first visit in the schedule, then this element is populated with the visit’s own title. For example, Screening Visit is displayed for the Screening Visit, as it is the first visit in the schedule. |
| DELAY_DAYS | The number of days between the prior scheduled visit. |
| DELAY_HOURS | The number of hours between the prior scheduled visit (in addition to the DELAY_DAYS field). |
| SCHEDULED_FROM_EVENT_REFNAME |
Displays the EVENT_REFNAME of the Scheduled From Visit as defined in the Visit Schedule. Note: If a visit is not scheduled or it is the first visit in the schedule, then this element is populated with the visit’s own refname. For example, SCREENINGVISIT is displayed for the Screening Visit, as it is the first visit in the schedule. |
Parent topic: Study Codelist dataset
Form folder
This table describes the data elements included in the Form folder.
Table 2-39 Data elements in the Form folder
| Data Element | Description |
|---|---|
| FORM_IS_REPEATING | Indicates whether the form is repeating. |
| FORM_IS_ROLLOVER | Indicates whether the form is rollover. |
| FORM_NAME | The name of the form, as specified by the study designer. |
| FORM_REFNAME | A form's reference name. |
| FORM_TYPE | Indicates the type of form:
|
Parent topic: Study Codelist dataset
Item folder
This table describes the data elements included in the Item folder.
| Data Element | Description |
|---|---|
| GROUP_TYPE | Indicates if this is a group question. |
| HIDDEN | Indicates if a question is hidden, as marked by a study designer. |
| ITEM_GROUP | If this is a group question, indicates the group question title. |
| ITEM_GROUP_ID | If this is a group question, indicates the group question ID. |
| ITEM_NAME | Indicates the title of the question, as entered by a study designer. |
| MEASURE_UNIT | Indicates the measure of unit specified by a study designer for a Number type of question. |
| QUESTION_HINT | Indicates information that a study designer provided as a hint to help answer a question. |
| QUESTION_TYPE | Indicates the type of question as defined by a study designer. |
| READONLY | Indicates that the question is marked as read-only by a study designer. |
| REFERENCE_CODE | Indicates a question's reference code. |
| SAS_LABEL | Indicates the SAS Label of a form defined by a study designer. |
| SAS_VARIABLE | Indicates the SAS Variable of a form defined by a study designer. |
| FORMITEM_IS_REQUIRED | Indicates if the question is required. Required questions must be answered in order to save the form that contains it. |
Parent topic: Study Codelist dataset
Audit folder
This table describes the data elements included in the Audit folder.
Table 2-40 Datat elements in the audit folder
| Data element | Description |
|---|---|
| IS_CURRENT | Audit trail field to display either current status or full audit trail of the data. |
| OBJECT_VERSION_NUMBER | Audit trail field that represents the version number of the data. |
| OPERATION_TYPE | Audit trail field that represents the type of operation performed (i.e. create, modify). |
|
SOFTWARE_VERSION_NUMBER |
A number that represents an incremental increase every time a data point is modified. |
| USER_NAME |
Audit trail field that represents the user who performed the action. The value for this column may represent a user's actual username or a user's email address, depending on how the user login was defined in Oracle Life Sciences IAMS. |
| VERSION_END | Indicates the date and time of when data was changed, if the data is not current. |
| VERSION_START | Indicates the date and time of when the data was changed. |
| CURRENT_STUDY_ROLE_NAME | Specifies of the role of the user who updated the given record. If the user's study role changes, this field will show the current study role of the given user. |
Parent topic: Study Codelist dataset
Reference folder
| Data element | Description |
|---|---|
| CODE_GROUP_WID | A number that represents the unique identifier of a codelist group. |
| CODE_VALUE_WID | A number that represents the unique identifier of a code value. |
| CODE_WID | A number that represents the unique identifier of a code record. |
|
EVENT_WID |
A number that represents the unique identifier of an event. |
| FORM_WID | A number that represents the unique identifier of a form. |
| ITEM_WID | A number that represents the unique identifier of an item. |
|
STUDY_WID |
A number that represents the unique identifier of the study. |
|
USER_WID |
Indicates a user's numeric identifier. |
|
CURRENT_STUDY_ROLE_WID |
Numeric identifier of the role of the user who updated the given record. If the user study role changes, this field will show the current study role of the given user. |
|
DH_TIMESTAMP |
A timestamp that indicates when the data became available in the dataset. |
This table describes the data elements included in the Reference folder.
| Data Element | Description |
|---|---|
| CODE_GROUP_WID | A number that represents the unique identifier of a codelist group. |
| CODE_VALUE_WID | A number that represents the unique identifier of a code value. |
| CODE_WID | A number that represents the unique identifier of a code record. |
| EVENT_WID | A number that represents the unique identifier of an event. |
| FORM_WID | A number that represents the unique identifier of a form. |
| ITEM_WID | A number that represents the unique identifier of an item. |
| STUDY_WID | A number that represents the unique identifier of the study. |
| USER_WID | A number that represents the unique identifier of an user. |
| CURRENT_STUDY_ROLE_WID | A number that represents the unique identifier of the user study role who updated the record. If the user study role changes, this field will show the current study role of the given user. |
| DH_TIMESTAMP | A timestamp that idicates when the transaction's data became available in the dataset. |
Parent topic: Study Codelist dataset