Study Design dataset

You can use the Study Design dataset data regarding the metadata of visits, forms and items included in study versions and applied across study versions and modes.

Modes

This dataset displays data collection design details of a study version available in any mode. However, this datset does not include study design details from any study version moved directly from draft mode to archived.

Note:

For a study version in draft mode to be available, you need to manually publish data by clicking Send to Analytics in the draft mode dropdown. This option is only available to the following template study roles:

Study Designer
View Study Design
Data Manager
User Administrator

What type of data can I include in a custom report or visualization on Data Collection design?

With this dataset you can:

Create a report to analyze data collection design and schedule
Identify visits schedule and forms design
Identify differences between study versions and modes
Verify changes made in a study version before moving it to production
Create a time and events table

For information about permissions required to access this dataset, see About your access to Oracle Clinical One Analytics.

Browse description 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 2-41 Data elements in the Study folder

Data element	Description
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.
DH_TIMESTAMP	A timestamp that indicates when the data became available in the dataset.
MODIFIED_BY	The user who last modify the study.
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.
OCC_ENABLED	Indicates if a study is currently enabled for Electronic Health Record (EHR) data import. No is displayed if EHR has never been enabled for a study or if a study was disabled for EHR.

Parent topic: Study Design dataset

Branch folder

This table describes the data elements included in the Branch folder

Data element	Description
BRANCH_TITLE	Indicates the branch title or name.
IS_CYCLE_BRANCH	States whether the branch is cycled.
CYCLE_COUNT	Specifies the number of cycles in case the branch is cycled.
ASSIGN_SUBJECTS_USING_TREATMENT_ARM	Indicates if subjects are assigned to the branch by Treatment arm.
ASSIGN_SUBJECTS_USING_FORM_QUESTION	Indicates if subjects get assigned to branch by a form question.
BRANCH_ARM	Specifies which treatment arm(s) correspond to the current branch, in case subjects are assigned to the branch by treatment arm.
BRANCH_FORM	Specifies which form contains the question used to assign subjects to the current branch, in case subjects are assigned to the branch by form question.
BRANCH_QUESTION	Specifies which question is used to assign subjects to the current branch, in case subjects are assigned to the branch by form question.
BRANCH_ANSWER	Specifies which exact answer to the selected question is used to assign subjects to the current branch, in case subjects are assigned to the branch by form question.
BRANCH_VISIT	Specifies the visit containing the selected form and question that is used to assign subjects to the current branch, in case subjects are assigned to the branch by form question.

Parent topic: Study Design dataset

Event folder

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

Table 2-42 Data elements in the event folder

Data element	Description
VISIT_IS_REQUIRED	Indicates if a visit is required.
IS_SCHEDULED_VISIT	Indicates if the visit is scheduled.
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.
VISIT_TYPE	Displays the type of visit: Screening, Randomization, Dispensation, Non-Dispensation, Optional, Withdrawal or Study Completion.
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: Visit_Complete Visit_Date_Changed VisitDateCleared VisitDateEntered Visit_Not_Started Visit_Skip_Undone Visit_Skipped Visit_Started Visit_Inserted: this option refers to new visits inserted into the study's schedule as an Advanced Study Versioning change.
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).
EVENT_TITLE	The event's title, defined by the user when an event is created.
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_ID_NAME	The event's id as in Oracle Clinical One Platform.
VISIT_HOUR_SEQ_ORDER	The order in which subject visits occur, as configured in the study design.
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_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.
ALERT_OUTSIDE_VISIT_WINDOW	Indicates if there is any rule set to alert if visit date is out of window. Values can be: Off Warning Query

Parent topic: Study Design dataset

Form folder

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

Table 2-43 Data elements in Form folder

Data element	Description
FORM_NAME	The name of the form, as specified by the study designer.
FORM_TYPE	Indicates the type of form: One-section form Two-section form Lab form
FORM_IS_ROLLOVER	Indicates whether the form is rollover.
FORM_IS_REPEATING	Indicates whether the form is repeating.
FORM_REFNAME	A form's reference name.
ALLOW_ADDITIONAL_ROWS	Indicates if this is a repeating form that allows additional rows.
SOURCE_DATAVIEW_NAME	If it is a copied form, indicates the original form it was copied from.
SOURCE_STUDY_NAME	If it is a copied form, indicates the name of the study it was copied from.
SOURCE_STUDY_VERSION	If it is a copied form, indicates the study version of the study it was copied from.
SOURCE_VERSION_START	If it is a copied form, indicates the date and time of when the copied data was entered.
RULE_COPY_STATUS	If it is a copied form, indicates the status of the source form rules copy.

Parent topic: Study Design dataset

Item folder

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

Table 2-44 Data elements in Item folder

Data element	Description
ITEM_NAME	Indicates the title of the question, as entered by a study designer.
GROUP_TYPE	Indicates if this is a group question.
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.
FORMITEM_IS_REQUIRED	Indicates if the question is required. Required questions must be answered in order to save the form that contains it.
READONLY	Indicates that the question is marked as read-only by a study designer.
SAS_VARIABLE	Indicates the SAS Variable of a form defined by a study designer.
SAS_LABEL	Indicates the SAS Label of a form defined by a study designer.
REFERENCE_CODE	Indicates a question's reference code.
ITEM_GROUP	If this is a group question, indicates the group question title.
HIDDEN	Indicates if a question is hidden, as marked by a study designer.
ITEM_VALUES	The raw value of the form question value (can be an array in questions with decodes). For more details see Form item output mapping in data extracts.
CODELIST_VALUES	Lists the codelist values added as answers to the current question.
VALIDATION_RULES	Specifies the question's validation rule if any. Validation rules types available depend on the type of question: Text questions: Doesn't contain Date/Time and Date of birth questions: After On or After Before On or Before On Not On Not Between Range Number and Age questions: Greater Than Greater Than or Equal To Less Than Less Than or Equal To Is Not Equal To Not Between Range Drop-down and checkboxes questions Select at Least Select at Most Select Exactly Answer Must Be Radio Buttons questions: Answer Must Be
RULE_ERROR	Reason for failure if validation status is failed or the rule validation failed.
ACTION_RULES	Details the action rule of a question which can be of the types: Show Question Show Form Show Visit Link & Show Form
SDV	Specifies if the question has any SDV parameter and if it is of the type SDV for All Subjects or Critical Variables (Targeted SDV).
CODE_QUESTION	If the question has a Coding Question property, lists the following information: Dictionary Coding Item Type Tag for Central Coding
FORMAT	Specifies the answer format. For example an specific date format, or the number of decimals after the point.
EHR_MAPPING	Displays the OCC data dictionary mapping value for a question mapped for Electronic Health Record (EHR) data import.

Parent topic: Study Design dataset

Reference folder

This table describes the data elements in the Reference folder.

Data element	Description
SOURCE_DATAVIEW_WID	If it is a copied form, indicates the numeric identifier of the form it was copied from.
SOURCE_STUDY_WID	If it is a copied form, indicates the numeric identifier of the study it was copied from.
STUDY_WID	A number that represents the unique identifier of the study.
BRANCH_WID	Indicates the unique numeric identifier of the branch.
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.
MODIFIED_BY_WID	The unique numeric identifier of the user who modified the study.
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.

Parent topic: Study Design dataset

Audit folder

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

Data Element	Description
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 Design dataset