The study functionality options are specific settings, among others in the Study Configuration, that can be enabled for your study. Each of those is defined in this article. Select the link on each description to read more about each in detail.
On the web:
On the app:
Randomization - Must be selected if you plan to randomize subjects in the study.
Use Inventory Management System - This enables inventory-related functions if products will be dispensed or tracked in conjunction with the study.
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.
Subject Events Page - This is enabled in most studies as it allows access to a subject's records. Occasionally studies are simple enough where scheduled visits and other forms are not required. In these cases, a single form can be managed from the subject enrollment table alone.
Study Timeout - Enforced only on mobile. This causes the user's session to timeout from inactivity. Note, mobile app operating systems will always cause the app to sign out when it is stopped in memory, regardless of this setting.
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 - This is used within the mobile app form builder. When creating new labels on forms, this default font will be used.
3. General Configurations:
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. To force this on new subjects, option 5 above must be enabled along with this option.
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 here - in which case the first subject generated would be "001".
4. 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. This option will not affect study behavior.
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 omitted (checked) by default to greatly speed up how fast forms load on web browsers.
Lab Range Validation - Enables the study to use site-specific lab range checks.
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. (New)
Use ICD-10 Dictionary - Enables an ICD-10 Lookup button on the top of all eCRFs for users to reference ICD-10 diagnosis and procedure codes/terms
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.
5. Record Audit
Audit changes to CRF - This causes the system to track events which occur on forms
Require reason for any change to CRF - This forces users to provide a reason after making changes to existing (previously saved) data. This must be enabled for full change audit tracking.
Use coded field for reason - This provides the users preset reasons for changing data (defined 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