Release Notes (v17.11)

The following features have been added and/or updated as part of the production release v17.11.

MRN Search

A new global search system has been added which allows quick navigation directly to the subject screen for any subject without needing to manually select the protocol and site and then scrolling through the subject list. Making use of the MRN search eliminates data errors due to source being uploaded and/or data entered for the incorrect subject.

Enabling a subject to be found via search is done by entering their Medical Record Number (MRN) when the subject record is created or updated. The MRN is secured with a one-way hash and the original number is neither stored nor displayed in the system.

 When searching by MRN, if only one subject is found then the user will be taken directly to the subject screen for the match. If multiple subjects are found with the same MRN, the user will be prompted to select the correct subject before being taken to the corresponding subject screen.

Certified Copies

Invalidating Pages

Individual pages of uploaded source documentation can now be marked as being invalid if they were uploaded in error or are no longer valid for the subject. Pages that have been marked as invalid will be displayed with a red X across the page when viewing the document and will be removed from the list of thumbnail images.

To mark a page as invalid…

1. Click on one of the document thumbnails to view the document
2. Right-click on the page to be invalidated
3. Click “Confirm” to verify the action

* Invalid pages are not deleted from the system and can be made valid again if necessary.

Improved Document Viewing

Viewing uploaded documents has been improved by opening and automatically scrolling to the page for whichever thumbnail was clicked. Previously the document would open to the first page regardless of which thumbnail was selected.

Training & Help

System Training

Users will now be provided training within the system. All users will go through new user training upon their first login to the system. Additional training will be presented on an on-going basis as features of the system are updated and introduced.

The training a user sees will be tailored to the role(s) they have been assigned. All training must be completed prior to the user gaining full access to the system. New user training will take 15-20 minutes to complete. 

In-App Help

Help within the system has been expanded and it is now easier to find answers to the most common questions. Help has been moved and can now be accessed from the navigation menu by clicking on your name in the upper-right corner and then selecting “Help” from the dropdown menu.

From the help window that is displayed, you can…

1. Search for help
2. Select one of the help articles listed
3. Send a message to the P1 Support Team

Contextual Tooltips

In addition to searching for help using the help window, tooltips have been placed at various locations within the system which when clicked will provide contextual help regarding the selected feature.

Access & Security

Expired One Time Passcodes

In the past, it was possible for an OTP to expire at the same time it was delivered to your inbox. Moving forward OTPs that are soon to expire will not be sent and instead your next valid code will be delivered giving you the full 5 minutes to complete your log in.

Session Timeout Warning

In order to prevent unnecessary session timeouts due to inactivity, you will now be prompted to renew your session prior to the timeout. After 14 minutes of inactivity an alert will be displayed giving you the option to renew your session. If you have not responded to the alert after 1 minute your session will then be timed out requiring you to log back in to continue working.

Procedure Listing Export

The Procedure Listing (available to Sponsor/CRO users) can now be exported to a csv file to allow custom reporting to be done. To export the listing, click on the download icon at the top of the Procedure Listing screen and choose the location to save the file. The data contained in the downloaded file will match whatever filter criteria that is currently applied on screen.

PI Acknowledgement

The previously built-in PI Acknowledgement functionality has been removed. As a replacement, your protocol may now include an “Investigator Agreement” site log which will allow a scanned version or picture of the signed agreement to be uploaded for each version of the protocol. This will provide a more flexible workflow by 1) not requiring the PI to log in to the system to sign, and 2) allowing easy access to view and download the original signed agreement.

EDC Updates

Field Draft / Saved Indicator

Data capture fields will now display a visual indicator letting you know:

1. When a field has been modified but not saved (yellow)
2. After confirmation is received that the change has been saved to the database (temporary blue).

Units and Reference Range Auto-Fill

Units of measure and reference range values can now be carried over from previous visits and auto-filled eliminating the need for manual data entry. Once units and ranges have been entered at a visit, the following functionality will be available at subsequent visits:

1. The last used values will be displayed
2. Pressing the keyboard down arrow will auto-fill the values
3. Pressing the keyboard up arrow will remove the auto-filled values (unless they have been changed)

PCS Workflow Renamed to Exceptions

In order to expand its use, the Potential Clinical Significance workflow has been renamed to Exceptions workflow. Items will now be flagged as an “Exception” at the point of data entry and the Exceptions workflow will allow these items to be categorized as Clinically Significant (CS), Not Clinically Significant (NCS), or as a Protocol Deviation (PD).