Study Design dataset

You can use the Study Design dataset to analyze and visualize data collection design data in Oracle Clinical One Analytics that will allow you to identify differences between study versions and across 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:

• Study folder
  
• Branch folder
  
• Event folder
  
• Form folder
  
• Item folder
  
• Reference folder
  
• Audit folder
  

Study folder

This table describes the data elements included in the Study folder

Table 2-39 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	The STUDY_ID_NAME data element that is converted to uppercase and spaces are removed. This value never changes after created even if STUDY_ID_NAME changes.
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.

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 or not.
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.

Event folder

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

Table 2-40 Data elements in the event folder

Data element	Description
VISIT_IS_REQUIRED	Indicates whether or not a visit is required.
IS_SCHEDULED_VISIT	Indicates whether the visit is scheduled or not.
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: Visit_Complete Visit_Started Visit_Date_Changed Visit_Inserted New visits added to the schedule and applied to a study using Advanced Study Versioning (ASV).
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.

Form folder

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

Table 2-41 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 or not.
FORM_IS_REPEATING	Indicates whether the form is repeating or not.
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.

Item folder

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

Table 2-42 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 whether the question is required or not. 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 whether a question is hidden or not, as marked by a study designer
ITEM_VALUES	The raw value of the form question value (can be an array in questions with decodes)
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

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.

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.