Study Design Delta report

This report assists study designers in identifying study design configuration differences and verify changes between study versions across modes before moving to Production.

Modes

Available for data in any mode.

Users that can run the report

Any user assigned the Run the Data Collection Design Dataset permission can generate this report. To save a copy in a different location, and to modify it you must have authoring access. See About your access to Oracle Clinical One Analytics.

You can create a story and either print or export your work in different formats to share your insights, see Export data analyses.

Note:

If you export Branch, Event, Form or Item details report as .csv file, Row Color and Rank columns are added at the end. These columns contain irrelevant information about how data is displayed and ordered in the UI, so they can be ignored for data analysis purposes.

Browse descriptions of data elements included in this report:

Parent topic: Standard report templates descriptions

Study design differences

This table describes the data elements included in the Study Design Differences section.

Data element	Description
Comparing Versions	Color legend listing the study versions being compared. Includes the following data of each version: 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_DESIGN_STATUS Indicates the study mode used in the referencing data in a custom report, such as Testing, Approved, or Archived. Note: Study versions can also have a Hisory status. A study design reaches this status when the study version is moved from Testing to Apporved. So, for example, if v1.0.0.24 is moved from Testing to Approved container, then it will become v1.1.0.24 and so it will get displayed in UI, having an Approved status. Study design v1.0.0.24 will still exist in the system with History status and it will be the same study design as v1.1.0.24 (Approved) but will not be seen in the Approved container in the UI. STUDY_VERSION Indicates the study version number of the referencing data in a custom report
Total Branch Differences	Indicates the total number of differences for branches between study versions.
Total Event Differences	Indicates the total number of differences for events between study versions.
Total Form Differences	Indicates the total number of differences for forms between study versions.
Total Item Differences	Indicates the total number of differences for items between study verisons.

Parent topic: Study Design Delta report

Branch Details

This table describes the data elements included in the Branch Details.

Data element	Description
Delta Exists	Y indicates a difference between versions and the row color represents in which version the branch exists. N indicates no difference between versions exists.
BRANCH_TITLE	Indicates the branch title or name.
BRANCH_ID	A branch's ID as specified by a study designer.
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.

Parent topic: Study Design Delta report

Event Details

This table describes the data elements included in the Event Details.

Data element	Description
Delta Exists	Y indicates a difference between versions and the row color represents in which version the event exists. N indicates no difference between versions exists.
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	The previous visit to this visit, as defined in the study design
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 started, visit completed)
DELAY_DAYS	The number of days between the prior scheduled visit
DELAY_HOURS	This column is reserved for future use
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	This column is reserved for future use
VISIT_WINDOW_AFTER_DAYS	Indicates how many days after the scheduled date and time the visit can occur, as entered by a study designer
VISIT_WINDOW_AFTER_HOURS	This column is reserved for future use
EVENT_TITLE	A visit or event's title as specified by a study designer
EVENT_REFNAME	A visit or even's reference code as specified by a study designer
EVENT_ID_NAME	A visit or event's ID as specified by a study designer
VISIT_HOUR_SEQ_ORDER	The order in which subject visits occur, as configured in the study design

Parent topic: Study Design Delta report

Form Details

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

Data element	Description
Delta Exists	Y indicates a difference between versions and the row color represents in which version the form exists. N indicates no difference between versions exists.
FORM_NAME	The name of the form, as specified by the study designer.
FORM_TYPE	Indicates the form type.
FORM_IS_ROLLOVER	Indicates whether or not it is a rollover form.
FORM_IS_REPEATING	Indicates whether or not it is a repeating form.
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 Delta report

Item details

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

Data element	Description
Delta Exists	Y indicates a difference between versions and the row color represents in which version the item exists. N indicates no difference between versions exists.
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
ITEM_TYPE	Indicates the item type.
QUESTION_TYPE	The form item's question type
QUESTION_HINT	Indicates information that can be provided as a hint to help answer a question.
FORMITEM_IS_REQUIRED	Indicates whether or not the question requires an answer
READONLY	Indicates that the question is in Read Only form
SAS_VARIABLE	Indicates the SAS Variable of a question defined by a study designer
SAS_LABEL	Indicates the SAS Label of a question defined by a study designer
REFERENCE_CODE	An item's reference code
ITEM_GROUP	If this is a group question, indicates the group question title.
HIDDEN	Indicates whether or not is hidden
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_RULE	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

Parent topic: Study Design Delta report