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 2-40 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	The STUDY_TITLE data element reflects the title of a protocol as defined by the study manager each time a new study version is created and renamed in the Study Mode section. For example, if the original study version is named P01_A23 in Active mode, that name appears as the STUDY_TITLE. If the study manager later creates a new version of the study and renames it to P01_A23_Production2, this new name will be displayed as the STUDY_TITLE for that version when used in Active mode. When you include multiple study versions in your dataset, and each has a different title, the STUDY_TITLE element will reflect the specific title assigned to each version. For example, your dataset might include study versions 1.0.2, 1.0.3, and 1.0.4. If the study manager renamed each version, you would see those unique titles in the dataset: P_01_A23 (for study version 1.0.2) P01_A23_Production2 (for study version 1.0.3) P01_A23_Production3 (for study version 1.0.4)
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.
REASON_FOR_REVISION	Indicates the user provided reason for revising the study version. This reason is provided when moving a study version from Test to Active container. If a value has not been specified for this element, its value displays as `NULL`.
VERSION_TITLE	Indicates the title of the study version. If a value has not been specified for this element, its value displays as `NULL`.
IS_APPROVED	This element aides in reviewing Archived study versions that may have been in the Active container in the past. It is applicable to all study versions, and is labeled N for any Study Version that was not moved to Active mode. It remains Y for study versions moved from Test to Active when those study versions are subsequently moved to archive.

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_SUBJECT_USING_TREATMENT_ARM	Indicates if subjects are assigned to the branch by Treatment arm.
ASSIGN_SUBJECT_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 2-41 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 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
EARLIEST_VISIT_TO_COMPLETE	When creating a study completion visit, you can specify an earlier visit that must be completed in order to enable the option for marking the subject as Complete. The reference name of that specified scheduled visit is provided in this field. This data element is added for each event. However, it is only specified when the record is for a Subject Completion event, while all other records display as a `NULL` value.
VISIT_ORDER	An integer indicating a visit’s ordinal position (order) within the visit schedule for the selected study version. These values may change across versions; for example, a visit that is in position 3 in version 1.0.0.1 may shift to position 4 in a later version if a new visit is inserted at position 3. Note: Ordinal values are study design attributes only and do not reflect a subject’s progress through a study or carry clinical significance. About draft study versions: VISIT_ORDER values won’t appear in the dataset for a draft study version until you either move the draft to the test container or choose Send to Analytics from the draft container menu. About visits: The dataset output displays scheduled (non-branch and branch) visits and unscheduled visits in the following manner. Scheduled non-branch visits (for example, a screening visit) are listed first, followed by scheduled branch visits, and finally unscheduled visits when the VISIT_ORDER is sorted in ascending order. Scheduled branch visits are assigned an ordinal value that reflects their position in a branch. When sorted in ascending order, visits from earlier tiers appear before those in later ones. Note: A tier—the highest level in visit branch design—is used to organize parallel branches, also called arms or cohorts. Each branch consists of a group of visits. For instance, a study includes two tiers (Tier1 and Tier2); each consists of two branches (BranchA and BranchB), and each branch contains a set of visits (Day1 and Day15). When sorted in ascending order, they appear as follows in the output. Tier1.BranchA.Day1 Tier1.BranchA.Day15 Tier1.BranchB.Day1 Tier1.BranchB.Day15 Tier2.BranchA.Day1 Tier2.BranchA.Day15 Tier2.BranchB.Day1 Tier2.BranchB.Day15 Unscheduled visits, which include Withdrawal, Screen Fail, Rescreen, and Study Completion visits, are assigned an ordinal value based on the sequence defined on the Unscheduled Visit or Event sidebar and appear after scheduled branch visits when VISIT_ORDER is sorted in ascending order.

Parent topic: Study Design dataset

Form folder

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

Table 2-42 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.

FORM_ORDER

An integer indicating a form's ordinal position (order) within a visit for the selected study version. These values may change across versions; for example, a form that is in position 3 in version 1.0.0.1 may shift to position 4 in a later version if a new form is inserted at position 3.

Note: Ordinal values are positive integers that indicate the sequence of forms in a visit as defined by the study design. They do not indicate if a form was started or completed and do not carry any clinical significance.

About Advanced Study Versioning (ASV): Duplicate FORM_ORDER values appear in the output when a new form is added using Advanced Study Versioning (ASV) and the dataset is generated for a previous study version. For example, study version 1.0.0.1 includes three forms, and study version 1.0.0.2 introduces a new form (Vitals). The output appears as follows when the dataset is generated for version 1.0.0.1. However, if the dataset is generated for version 1.0.0.2, no duplicate values appear and the order is sequentially correct.

FORM_NAME	FORM_ORDER
Screening	1
Baseline	2
Vitals	2 (3 when generated for 1.0.0.2)
Study Completion	3 (4 when generated for 1.0.0.2)

Parent topic: Study Design dataset

Item folder

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

Table 2-43 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. For example:

Text
Number
Age
Date/time
Drop-down
Radio buttons
Checkboxes

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.

DATA_CLASSIFICATION

Indicates how the data is categorized according to its sensitivity and intended use. Applicable only to hidden items.

This data element populates with a comma separated list of all the selected data classification groups of a hidden item. Possible values for this element include:

Adjudication data
Blinded data
PII data
Public data
Sponsor data

DATA_TYPE

Indicates the data format of the collected data. For example:

VARCHAR
NUMBER
DATETIME
ODM

APPLY_CHANGE_VERSION

Indicates the version in which changes to the form item apply.

This data element refers to the lowest study version in which the change occurs; all study versions between the APPLY_CHANGE_VERSION and current study version are included in the change.

ITEM_ORDER

An integer indicating a question's ordinal position (order) on a form for the selected study version. These values may change across versions; for example, a question that is in position 3 in version 1.0.0.1 may shift to position 4 in a later version if a new question is inserted at position 3.

Note: Ordinal values are positive integers that indicate the sequence of questions on forms as defined by the study design. They do not indicate if a question was answered and do not carry any clinical significance.

About Age items on forms: When an Age item is added to a form, the system also adds a Date of Birth field and displays them together, making it appear as a single question in the study design. In the study design dataset, however, Age (a calculated item) and Date of Birth are recorded as two distinct items, each on its own row with a unique ordinal value.

ITEM_GROUP_ORDER

Indicates the order of items on two-section forms and in question group type questions.

For example, a study's design includes a question group labeled Scan 1 with two questions: Scan Date and Upload Scan. In the output, the ITEM_GROUP is repeated for each question in the group, and ITEM_GROUP_ORDER reflects each question’s position within the group. In the design, the group is treated as a single question, so if ITEM_ORDER is present, it is the same for all items.

ITEM_GROUP	ITEM_NAME	ITEM_GROUP_ORDER	ITEM_ORDER
Scan 1	Scan Date	1	1
Scan 1	Upload Scan	2	1

Note: For any other form or question types, ITEM_GROUP_ORDER is NULL..

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