Remote Clinical Trial Monitoring

Remote Monitoring

This is a reminder that clinical research sponsors/monitors are still not permitted on site. All monitoring visits, site qualification visits, site initiation visits and/or site close out visits must continue to be conducted remotely.  (The one exception applies to those device studies for which the vendor must come on site to provide the investigational device for a specific surgical/medical procedure.) 

There are four options for sharing information with study sponsors.  All four have been approved for use with patient (subject) related activities. You are not required to redact the information you share using these tools.

EpicCare Link

Monitors can obtain a EpicCare Link account to obtain access to the Epic medical records for specific subjects/patients.

For more information, click here.

WebEx

Team members can use Webex to conduct virtual meetings through video or conference line.

For more information, click here.

Secure E-Mail

Team members with a health system email account can send secured e-mails.

For more information, click here.

Although secure e-mail is an acceptable option, HIT security asked that it be used as a last resort.  They prefer that WebEx or Dropbox is used whenever possible when sharing information that is not accessible via EpicCare Link.

Dropbox

Team members can Dropbox, a secure cloud storage to store, sync, and share data files  Dropbox:

For more information, click here.

When using Dropbox for this purpose, you must set an expiration date and password.

Instructions: Using “Dropbox Transfer” to send PHI

 

Data Security Plan (During the pandemic)

We realize that you have not included all of these options in the Data Security Plan (DSP) approved for your studies.  HIT Security agreed that you may move forward with using these without first updating your DSP.  However, we must be able to provide them with a list of studies that utilize any of these tools.  The SOM CTO has agreed to maintain this list.  So, if you plan to utilize these options and they are not in the current approved DSP, please contact Patricia Moss and provide her with the following information:

  • IRB #
  • PI
  • Which tools you plan to utilize