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.

Browse descriptions of data elements included in this dataset:

Note:

Blank columns in Oracle Clinical One Analytics indicate null or not applicable.

Parent topic: Dataset descriptions

Study folder

This table describes the data elements included in the Study folder

Table 3-37 Data elements in the Study folder

Data element Description
STUDY_MODE
Indicates the study mode used in the referencing data in a custom report. Values can be:
  • Testing
  • Training
  • Active
STUDY_ID_NAME

The study ID as specified when the study was created. The study ID typically includes the protocol acronym or protocol number and must be unique within a tenant.

You can view or update this value in Clinical One Cloud Service from the General tab of the Study's settings.

STUDY_TITLE

The Study Title as specified when the study was created.

You can view or update this value in Clinical One Cloud Service from the General tab of the Study's settings.

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

The study phase as specified when the study was created.

You can view or update this value in Clinical One Cloud Service from the General tab of the Study's settings.

The study phase is specified by selecting an option from a drop-down list of options, which is populated with the labels from the studyGeneralSettings.studyPhase codelist within the system codelist selected for the study. Users with the appropriate permissions can update codelists used within a study at any time. See Create and manage code lists.

THERAPEUTIC_AREA

Indicates the therapeutic area as specified when the study was created.

You can view or update this value in Clinical One Cloud Service from the General tab of the Study's settings.

The therapeutic area is specified by selecting an option from a drop-down list of options, which is populated with the labels from the studyGeneralSettings.therapeuticArea codelist within the system codelist selected for the study. Users with the appropriate permissions can update codelists used within a study at any time. See Create and manage code lists.

BLINDING_TYPE

Indicates the blinding type of the study (whether the study is open-label or blinded) as specified when the study was created.

You can view or update this value in Clinical One Cloud Service from the General tab of the Study's settings.

The blinding type is specified by selecting an option from a drop-down list of options, which is populated with the labels from the studyGeneralSettings.openLableBlinded codelist within the system codelist selected for the study. Users with the appropriate permissions can update codelists used within a study at any time. See Create and manage code lists.

STUDY_VERSION

Indicates the study version of the referencing data in a custom report.

The study version is associated to a subject and corresponds to that on which a subject was added to the study. This value does not change for a subject, regardless of the creation of new study versions for a given mode.

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 Clinical One Cloud Service.
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. If it includes a custom codelist, this value indicates whether it is a static or dynamic 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.
SITE_ASSOCIATION

Indicates which sites in that mode the code list is mapped to with a value of either ALL SITES or an alphabetical list of the sites based on site ID.

Note: This field only populates for study level codelists.
CODELIST_MODE Indicates the mode in which the associated site was created (Training, Testing, Active).

Parent topic: Study Codelist dataset

Event folder

This table describes the data elements included in the event folder.

Table 3-38 Data elements in the event folder

Data element Description
EVENT_ID_NAME The event's id as in Clinical One Cloud Service.
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 Clinical One Cloud Service 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 impacts a visit. Upon selecting this data element, only events that occurred in your study are displayed. This data element displays any of the following events:
  • VisitDateCleared: the visit date was cleared.
  • VisitDateEntered: the visit date was entered.
  • VisitDispensed: dispensation occurred during the visit.
  • VisitRandomized: randomization occurred during the visit.
  • VisitRandomizedDispensed: dispensation and randomization occurred during the visit.
  • VisitScreened: screening occurred during the visit.
  • Visit_Complete: the visit was completed.
  • Visit_Date_Changed: the visit date was changed.
  • Visit_Hide: the visit was hidden.
  • Visit_Inserted: a new visit is inserted into the study's schedule as an Advanced Study Versioning change.
  • Visit_Not_Started: the visit is associated to the subject but is not yet started.
  • Visit_Show
  • Visit_Skip_Undone: the visit was previously skipped, but the skip action was undone.
  • Visit_Skipped: the visit was skipped for the subject.
  • Visit_Started: the visit was started for the subject but hasn't progressed all the way to complete.
  • Visit_Scheduled: the visit is associated to the subject as part of their schedule.
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
  • 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, if 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 that visit’s own refname..

Parent topic: Study Codelist dataset

Form folder

This table describes the data elements included in the Form folder.

Table 3-39 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:
  • One-section form
  • Two-section form
  • Lab 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. For example:|
  • Text
  • Number
  • Age
  • Date/time
  • Drop-down
  • Radio buttons
  • Checkboxes
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 3-40 Data elements in the audit folder

Data element Description
IS_CURRENT Audit trail field to indicate if the record represents current data. Displays:
  • Y for Yes.
  • N for No.
OBJECT_VERSION_NUMBER Audit trail field that represents a sequential number for records about operations on a same element.
OPERATION_TYPE Audit trail field that represents the type of operation performed on the record:
  • CREATED: a given action resulted in a new record.
  • MODIFIED: a given action resulted in the update of an existing record.
  • REMOVED: a given action resulted in the data removal for an existing record.
  • CLEARED: a given action resulted in the clearing of data for an existing record.

SOFTWARE_VERSION_NUMBER

A number that increases incrementally every time a data point is modified.
USER_NAME

Audit trail field that represents the user who performed the action that generated the record.

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

As this dataset contains past and current records, the version end indicates the date and time when a change was applied that made the given record to stop being current.

If the record is current, then the version end is not defined, and '31/12/3099 12:00:00 a.m.' displays by default.

VERSION_START

As this dataset contains past and current records, the version start indicates the date and time when a given record was created.

To be used in combination with VERSION_END to determine if the record is current or version ended.
CURRENT_STUDY_ROLE_NAME Specifies of the role of the user who performed the action associated to the given record.

Even if the user's study role changes, this field always shows the current study role of the given user.

Parent topic: Study Codelist dataset

Reference folder

Note:

Although WID values are unique identifiers at the study level, they may change over product releases and should not be used as identifiers in your reports.
Data element Description
CODE_GROUP_WID

A number that represents the codelist group, as a unique identifier within the study.
CODE_VALUE_WID

A number that represents the code value, as a unique identifier within the study.
CODE_WID

A number that represents the codelist, as a unique identifier within the study.

EVENT_WID

A number that represents the event, as a unique identifier within the study.
FORM_WID

A number that represents the form, as a unique identifier within the study.
ITEM_WID

A number that represents the form item, as a unique identifier within the study.

STUDY_WID

A number that represents the site, as a unique identifier.

USER_WID

A number that represents the user, as a unique identifier within the study.

CURRENT_STUDY_ROLE_WID

A number that represents the role of the user who updated the given record, as a unique identifier within the study.

Even if the user study role changes, this field always shows the current study role of the given user.

DH_TIMESTAMP

A timestamp that indicates when the data became available in the dataset.

Parent topic: Study Codelist dataset