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Research Administration 350 West Thomas Road Phoenix, Arizona 85013
Office: 602-406-4114 Toll Free: 866-367-4373
Page 1 of 2 Remote Monitoring Guidance V1.0 17MAR2020 Distributed by Meghan Hall
Remote Monitoring Visits
Below is an outline of expectations for research staff at Dignity Health facilities regarding the conduct and participation in remote monitoring activities.
Study Staff Expectations:
Remote monitoring visits are an efficient way for Sponsors to review data to help ensure the quality and conduct of the study without having to be physically onsite. It is important they all remote monitoring visits are planned in advance and the Sponsor has communicated expectations for the visit that align with internal DHRI-AZ policies.
Dignity Health/CommonSpirit Health recommends the use of Box.com, a cloud base file sharing service, to facilitate the sharing of any documentation with PHI. The CommonSpirit Health Box Platform has been extensively vetted and approved by the organization as a HIPAA compliant file sharing platform. If you do not currently have access to Box, please communicate with your leader who can request and approve access on your behalf.
If a Sponsor requests to schedule a remote monitoring visit, and requests to review selected source documents as part of the remote monitoring activity, the study staff should encourage the use of Box.com to share the requested documents, unless the Sponsor has an alternative secure file sharing platform to share study/source documentation. If you elect to use Box.Com please review the attached instructions for creating and sharing a box folder. (See attached requirements for folder settings of Box folder. Box folder is only to be shared with study monitor conducting the remote monitoring visit).
Once the remote monitoring visit is scheduled, and you have agreed that you will use a Box folder to share study documents, provide Sponsor with instructions on how to access Box folder (see attached instructions).
Upload requested copies of the requested documentation such as CRFs (source documents), progress notes, and medical records (if requested), at least one day prior to the remote monitoring date.
Ensure that data for all enrolled subjects is entered into the Electronic Data Capture System prior to this remote monitoring visit.
All queries and action items identified as a result of the remote monitoring visit are done so within the time frame outlined from Sponsor.
Research Administration 350 West Thomas Road Phoenix, Arizona 85013
Office: 602-406-4114 Toll Free: 866-367-4373
Page 2 of 2 Remote Monitoring Guidance V1.0 17MAR2020 Distributed by Meghan Hall
All Sponsor Representatives added to a Box folder should be added as a “previewer” collaborator only, this will allow the CRA to view the uploaded documents without having access to download. Uploaded documents should only be made accessible to the previously identified folder collaborators. Access to the documents should be limited and last for the duration of time specified in the confirmation letter (approximately 48 hours). Following the completion of the remote monitoring visit the collaborator access should be removed and the folder should be deleted.
Sponsor Expectations:
Sponsors should notify research study staff at least 7 days in advance of Remote Monitoring visit date. The Sponsor should confirm the following:
• Date remote monitoring visit will occur
• List of which copies of source documents are required to upload and themechanism in which source documents are going to be virtually shared.
• Expectations for query resolution timeline following remote review
At the completion of the Sponsor’s remote review you should receive follow-up communication regarding a list of action items, queries, and any corrective action plans that may need to be developed as a result of remote visit findings.
If follow-up communication is required (teleconference, etc.) this will be communicated and scheduled with the Site Investigator and Coordinator to discuss any outstanding trends per the Sponsor’s policies.
Sharing via Box.com
• Share folders (two approaches to invitation)• Person with whom you are sharing the folder is a “Collaborator”• Several permission levels, gets set when you send invitation• Invitee will need to create a Box account• Invitee has access to ALL items and subfolders within shared folder
• Perhaps create study folders that are not shared, then make site-specific subfolders thatget shared, all study staff of each site receive individual invitation
• Share “Link”• No Box account required, but cannot upload documents
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CRA perspective, from within Dignity Health network
Start with the web-based interface
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Click “+New” for drop-down menu
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Method #1: Invite “collaborators” when creating the new folder
This triggers dialog box
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Editor: Upload, Download, Preview, Share, Edit, and Delete files
Co-Owner: All permissions, except cannot change access level of owners
Viewer Uploader: Upload, Download, Preview, Share, and Edit files
Previewer Uploader: Upload and Preview files only
Viewer: Download, Preview, and Share files
Previewer: Preview files only
Uploader: Upload Files only
Method #1: Invite “collaborators” when creating the new folder
Name folder, invite collaborators, assign permissions
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Method #1: Invite “collaborators” when creating the new folder
Capabilities of each permission setting
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Method #2: Creating the new folder, invite “collaborators” later
Other method…
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Method #2: Creating the new folder, invite “collaborators” later
Name folder, invite collaborators later
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Method #2: Creating the new folder, invite “collaborators” later
After folder created, then invite collaborators
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Method #2: Creating the new folder, invite “collaborators” later
Inviting collaborators to existing folder
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Method #2: Creating the new folder, invite “collaborators” later
Inviting collaborators to existing folder
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Content through link: No Box account needed, but no uploading capability
Inviting collaborators to use link instead of folder
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Share content through link: No Box account needed, but no uploading capability
Inviting collaborators to use link instead of folder
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Share content through link: No Box account needed, but no uploading capability
Inviting collaborators to use link instead of folder
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INSTRUCTIONS FOR SPONSOR REPRESENTATIVES ON HOW TO ACCEPT AND ACCESS BOX FOLDER FOR REMOTE
MONITORING
Step 1 – Box.com invitation
Click on “Accept Invite” box.Launches new window, To sign up or log in.
Step 2 – Create free account, or Log In
NOTE: If creating free account for the first time, there will be two additional screens with options for “personalizing”your experience. Neither step is required, each page can be skipped. You may also be asked to reset your password, which does not indicate any problem with your account.
Step 3 – You’re done!
Please contact our resreach site with any questions or concerns about this process!
