Documentation corrections

Lists documentation issues corrected in this release, including clarifications, fixes, and updates to improve accuracy and usability.

Table 3-1 Analytics User Guide

Issue ID Details
38697392

Added a note to the IS_CURRENT element description (for applicable datasets) clarifying that for repeating, two-section, and lab forms, IS_CURRENT is populated for both form-level records and repeating-row records.

38837638

Added a note to the SUBJECT_NUMBER description (in the Subject Folder) for the Subject Forms dataset, clarifying that NULL is displayed when a subject is removed using the Undo Add Subject feature.

Note: See the Site User Guide table for the additional change included in this fix.

39034588 Moved FORM_RESTORED in the Subject Forms dataset from the FORM_STATUS data element description (in the Form (Required) folder) to its own row in the Audit folder.
38956950 Updated the ITEM_ORDER item's description clarifying it is study-version specific, and may appear as decimals when items are inserted without renumbering, and may be re-sequenced to consecutive integers in later/latest versions. Also clarified it reflects form sequence only (no completion/clinical meaning), provided an example and added a note. For more information see the Study Design Dataset, Item folder.
39121348 Updated the QUERYAGE calculations descriptions for Active (days since first opened to today), Closed (first opened to closed date), and Audit/Version-ended records (opened to when that query version ended). For more info, see Query folder.

Table 3-2 Reporting Guide

Issue ID Details
38699759

Corrected the Fields in General Enrollment table to clarify that Screened Subject includes Completed and Withdrawn (in addition to New, Screened, and Screen Failed). For more information, see Study Enrollment report.

38512003 Added clarifying notes to the User Name and Location filters to explain the scope of included training data: filtering by a specific user includes all associated training regardless of user status, while filtering by a specific site includes training data only for active users at that site. For more information, see Clinical One Training report.
38981090 Added a concept note to clarify that predicted kit quantities for calculated doses are shown only when the dosing form is completed and the same calculated-dose form is used across visits; otherwise predictions may not be generated. For more information, see Subject Visits (Unblinded) report.

Table 3-3 Rules Developer Guide

Issue ID Details
38384443 Added a note in the Parameters section for the findMinDateIn2SForm( ) and findMaxDateIn2SForm( ) helper functions, clarifying that they do not support being passed variables that reference unscheduled visits.

Table 3-4 Site User Guide

Issue ID Details
38837638 Added a note in Step 6. of the Cancel a subject procedure clarifying that NULL is displayed when a subject is removed using the Undo Add Subject feature.
38878742 Added a tip to the first bullet in the Before you mark a visit that a subject missed, consider the following section of Mark a visit that a subject misses as skipped, explaining how to correctly clear data.
38993250

Updated the first bullet under Step 6. Enter data in a form to clarify that users should open each repeating form row in full view by selecting the row number, rather than entering data cell-by-cell directly in the table. Added a note describing potential impacts of cell-by-cell entry, including incomplete saves (especially for date fields) and dynamic questions not appearing. For more information, see Enter data in a repeating form.

Table 3-5 Sponsor and CRO User Guide

Issue ID Details
38695345 Added a tip to the Notification setting describing recommended configuration for the Subject Limit and Notification settings when creating or editing custom enrollment groups.
38948566 Added guidance to clarify how to create an initial shipment in a min/max resupply strategy, namely to enter a value greater than 0 for at least one kit type in the Initial Shipment section so the system can generate the shipment when the study’s initial-shipment trigger occurs (for example, site activation or after the first subject visit). For more info, see Create a min/max resupply strategy.

Table 3-6 Study Designer Guide

Issue ID Details
38979089 Added a note to the Restart Cycle Numbering setting, clarifying that it appears only when creating a second or subsequent cycling branch. For more information, see Create a visit branch.