Device for Participant Use

The project team will need to work ITG to obtain a device, such as tablet, laptop or desktop, that is approved for participant use. It would be a violation of OHSU Privacy and Security policies for participants to use a project team member's personal work computer or an OHSU employee work station, or a project team member's personal device, such as team member's personal phone, tablet or laptop.

• It is the project team's responsibility to maintain the device per OHSU policies and ITG's guidance.
• If the project will be collecting data during remote in-person encounters, such as home visits, school visits, outreach activities, etc, the project will need to ensure the device has a reliable internet connection, which may involve purchasing a data plan, as wifi connections may be unreliable or unavailable in remote locations.

Opening the Survey Link for the Participant

It is critical for study staff to use the method outlined below to securely open the survey for the participants to complete in a manner that mitigates and/or eliminates the following the risks:

• Over-writing the participants response
• Creating a reportable regulatory issue
• Violating OHSU privacy and security policies
• Creating a HIPAA violation

Method for Securely Opening Link

To securely open a survey link for the participant to complete their survey requires staff use the Log Out + Open Survey feature, as follows:

• On the device approved for participant use, study staff log into their REDCap project.
• Study staff select the participant's record and navigates to the survey/form the participant needs to complete.
• From the Survey Options drop-down at the top right of the survey/form, staff selects the option, Log Out + Open Survey (see the image below).
  
• This action logs the staff out of REDCap and loads the login page, and opens the form as a survey in a new tab or window.
• Staff closes the tab with login page loaded.
• Staff turns over the device to the participant with tab or window open with the survey loaded.

User Rights

Staff managing in-person survey collection, will need permission to the Survey Distribution Tools, to access the Survey Options drop-down and select the Log Out + Open Survey option.

What Happens When Study Staff Open Survey without Logging Out

When study staff use the Open Survey option, instead of the Log Out + Open Survey option, there will be two tabs or two windows open, one with survey open for the participant to complete, and another with the REDCap project open and the study staff logged in.

This means that when the study staff turn the device over to the participant the study staff risks exposing the project and the data in the project to the participant, and introduces the opportunity for the participant to impersonate the staff as a REDCap user. This could result in reportable compliance violations with OHSU privacy and security policies and regulatory requirements, and if the project is collecting any PHI, there could be a HIPAA violation.

Even if the study staff monitor the participant's use of the device, to ensure the participant does not navigate away from the survey to other tabs or other applications, there is risk staff will overwrite the participant's submitted response when the study staff navigate back to the window of tab where they left the the form open in the REDCap, if they incorrectly respond to a prompt from REDCap to leave the page, and instead opt to Stay on page (see the image below), and then click one of the save options.

Paper Backup

We recommend study staff maintain up-to-date paper copies of surveys that participants are expected to complete in REDCap during in-person encounters as backup in the event the device or internet connection fails in such a way the participant cannot access their surveys in REDCap.