Study Functionality Configuration is where some of the basic study capabilities can be enabled or disabled.
Access the Study Functionality from Study Configuration in the main menu:
See the definition of each item below the image.
- Site Document Manager - All studies will have this enabled regardless of this option being checked.
- 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 in the study.
- ePRO Enabled Study - This enables a new column in the subject enrollment table with a link to each subject's ePRO sign in information.
- Save and Next -
Save and Next allows the study builder to optionally add a window at the bottom of a CRF that allows the user to navigate forward or backward. There is also a button in the middle of the window that allows the user to save the form and advance to the next page. If the user is on the last page of the form and they arrived there by using the save and next button, then the button will say save and quit. That save from the last page is NOT a draft save but rather a final save. It also quits the form and returns to where it came from.
In order for a form to use this, the following must be set:
- Study Configuration - Save Draft Records
- Form Properties - Save Draft and Next
- Form must have multiple pages
Once a form has been saved as non-draft, the save and next button will stop appearing.
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-generate 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-generate 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 number and format specified here.
Subject Events and Records
- 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.
- 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. It's important to consider draft record saving will not track data changes in audit trails.
- 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 the study behavior.
- Omit Record Index in CRF - This will disable a link built into forms, when being viewed on the web, that allows users to view the list of forms collected for the current subject without needing to leave the form they are currently working on. This feature is omitted by default to greatly speed up how fast forms load on web browsers.
- Audit changes to Subject CRF - The system will track all data entered and changed on subject CRFs.
- Require reason for any change to CRF - When data is changed on CRFs after the first save, the system prompts users to provide reasons for changing data.
- Use coded field for reason* - Create pre-designed reasons for changing data that users can choose from when they make changes to CRFs. This makes it easier for users versus manually typing in reasons.
- Allow First reason to be used in all other - Speed up the process of data change reason entry by allowing users to populate the same choice of change reasoning on all fields that are changed.
Note: The options * above cannot be changed after subjects exist in the study, even if they are test subjects. To begin with a clean study, either create a new study (copy) or clear all subject data.