Summary
The study functionality options are specific settings that can be enabled for your study. They are configurable on the Web under the Study – Study Configuration option.
1. Study Status Controls - This controls the status of the study for data entry. It provides an overview of Status History, as well as a Change Study Status section where updates to the status can be applied.
2. Functionality Configuration Options – These various options allow functionality settings to be applied to each Study. In the iOS app, options appear in sections with Headers (each section Header is underlined below). On the Web each option is listed under the Functionality or Audit tab (as defined below).
General Configurations:
Site Document Manager – This should be checked for all Studies. All Studies will have this enabled regardless of the selection made at the app or web.
Enforce Version Control* - This enables study versioning and is used in most studies as it allows for making controlled post-production changes to the study or form design. This option cannot be changed after data is entered into the study.
Use Two-Factor Authentication – When enabled, a user will be required to enter a Two Factor Authentication code when attempting to access the Study for the first time on a new device.
Display Participant Timeline – When enabled, the study will provides access to the Participant Timeline report on iOS for Patient users.
Blind Participant Email Address – Hides Participant email address for that study in the Sign in Audit Report when enabled.
ePRO Enabled Study - This enables a new column in the subject enrollment table with a link to each subject's ePRO sign-in information.
Default Font (iOS only) - This is used within the mobile app form builder. When creating new labels on forms, this default font will be used.
Blind Participant Email Address – Hides Participant email address for that study in the Sign in Audit Report when enabled.
Subject Profile ID Generation:
Force Subject Profile ID Auto-Generate - Forces users to use a link on the subject enrollment table for the system to automatically generate a profile ID for a newly enrolled subject. If this option is not checked, the auto-generated link may still be available, but the system will also allow the user to manually change or enter a profile ID.
Omit Subject Profile ID Auto-Generate - Removes the auto-generated link option from the subject enrollment table. Users will need to manually enter a profile ID for new subjects.
Use Site ID Number for Subject Profile ID Auto-Generate - Uses the site ID number from the Site Manager as part of auto-generated subject profile IDs.
Study Wide Subject Profile ID Sequencing* - When auto-generation of profile ID is used, with this option enabled, the system will sequence subject profile IDs across all sites of the study. With this option not checked, the system will default to sequencing subject IDs independently within each site.
Starting Sequence Number* - When auto-generation of profile ID is used, the system will begin with the "0001" unless another format such as "001" is specified herein which case the first subject generated would be "001".
Subject Events and Records
Allow Subject Forms to be saved as Draft - This places an option on each form to save as draft. This option will allow users to save data entered on forms without the system running any edit checks or firing unnecessary queries on forms before they are finished completing it.
Note: Draft saving does not track the "DATA CHANGES" in form if data is changed. Only saving data as final will start the "Data Changes" audit and you may be prompted to input a reason for data change per 21 CFR Part 11 guidelines. The form will show as "Record Saved as Draft" in the audit trail and simply update each save of form in that draft state.
Use Interval Date Entry - Allows for dates to be entered on scheduled visit intervals so users do not need to enter a date on every form within the intervals. If this option is enabled, the individual forms must also be configured for Interval date entry in the Form Builder.
Suppress Visit Outside Window Error Checking - Forces the system to NOT check the dates entered on scheduled visits as being within their scheduled window. This option is normally left unchecked as forms can individually be configured to suppress VOW error checking in the Form Builder.
Field Level Verification - Field level source verification (risk-based monitoring) is set up in the study Workflow and the Form Builder. Enabling this option alone will not affect study behavior, however this works in conjunction with those Workflow and Form Builder settings.
Omit Record Index in CRF - This will disable a link built into forms that allow users to view the list of forms collected for the current subject without needing to leave the form they are currently working on and allows them to arrow forward/backward to the next form in sequence order by DATE of the form if entered. A warning message is there to remind you to save data to prevent data entry loss.
NOTE: This feature is checked by default to greatly speed up how fast forms load on web browsers.
Omit date from scheduled visit table - Hides the date windows and target date that is normally displayed in the scheduled visit grid within a subject's records. Note, all date calculations are still happening in the background - including missed visits or forms that are entered outside the allowed window.
Enable Study Cohorts - Enables functionality to add multiple cohorts within the visit schedule set up and adds a new column in the subject manager to see which cohort each subject is currently on.
Subject Events Page - This should be enabled as it allows access to a subject's records.
Allow ePRO Users Access to Unlocked Forms - Allows patients to access completed forms through the patient portal.
Allow ePRO Users Access to Expired Forms - Allows patients to access expired forms through the patient portal. Expired forms are those ePRO forms that are part of a Scheduled Visit where the window has passed.
Default to Single Interval Page – When enabled, the study Scheduled Visits screen in the Subject Manager is displayed as Drop Down view as a default on the app.
Record Audit (Audit tab on the Web)
Audit changes to CRF - This should be enabled, and forces the system to track events that occur on forms as part of an audit event.
Require reason for any change to CRF - This forces users to provide a reason after making changes to existing (previously saved) data.
Note: This must be enabled for full change audit tracking.
Use coded field for reason* - This provides the users preset reasons for changing data (defined in Change Reason Coding below)
Allow first reason to be used on all others - This adds convenience for users to quickly apply one reason to all other changes that occurred in that same save event. Otherwise, the user must individually provide reason separately for every change.
Change reason coding - Configure the reasons users can provide for changing data. Changes made here
Note: The options marked with an asterisk (*) above cannot be changed after subjects exist in the study, even if they are test subjects. To start with a clean study, either create a new study (copy) or clear all subject data using the Remove All Data link under the Remove Subject CRF Data section of the Study Configuration – Functionality screen.
