Enhancements to the Study Design dataset

The dataset now includes new elements allowing users to view and sort details based on the ordering of visits, forms, and items. The dataset also includes new elements that detail data classification applied to items, additional information when changes are implemented using Advanced Study Versioning, and details at a version level that inform users of the justification/reason for a new version and if the new version has ever been applied to the active mode container.

New data elements to view ordinal values for visits, forms, and questions

Ordinal values are integers that indicate the order of visits in the visit schedule, the sequence of forms within visits, and the placement of questions on forms for a selected study version. They are study design attributes only and do not reflect a subject’s progress through a study or carry clinical significance. You can find additional information about the following new data elements in the Analytics User Guide after the assessment environment upgrade.

Table 1-3 New dataset elements

Data element	Folder	Description
VISIT_ORDER	Event	Indicates 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. 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. 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.
FORM_ORDER	Form	Indicates 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. 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)
ITEM_ORDER	Item	Indicates 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. 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	Item	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.

New data elements to view data classification and design details

Now, the same information visible in the user interface (UI) is accessible in the Study Design dataset when retrieving data through APIs and when working in Oracle Clinical One Analytics. These updates apply only to design data and do not impact runtime.

The following new data elements are included in the Study Design dataset:

Data element	Folder	Description
REASON_FOR_REVISION	Study	Indicates the user provided reason for revising the study version. This reason is provided when moving a study version from Test to Active container.
VERSION_TITLE	Study	Indicates the title of the study version.
IS_APPROVED	Study	Indicates whether or not (Y or N) the study version was ever in the Approved container, which is especially useful for archived study versions.
EARLIEST_VISIT_TO_COMPLETE	Event	When setting up a study completion visit, you can designate an earlier visit that must be completed before the option to mark the subject as Complete becomes available. The reference name of the required scheduled visit is specified 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.
DATA_CLASSIFICATION	Item	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	Item	Indicates the data format of the collected data. For example: VARCHAR NUMBER DATETIME
APPLY_CHANGE_VERSION	Item	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 inclusive of the APPLY_CHANGE_VERSION and current study version are included in the change.

You can find additional information about this dataset and the new data elements in the Analytics User Guide after the assessment environment upgrade.