The SUT serves as the master record for users and shipment information and is critical to AiCure operations for the study. The SUT will be utilized by AiCure to execute contracted operations for the study, including but not limited to:

• User accounts - granting, revoking, or  access
• Site SIV Dates
• Red alert email distribution list
• Weekly reporting distribution list
• Clinical Site Services outreach and monitoring reports
• Technical support ticket resolution
• Provisioning of initial, resupply, or replacement device requests

This PowerPoint outlines the requirements for formatting and submission to AiCure.

 

Authorized Requestor(s)

As this document captures user access information to the AiCure Platform with study data and shipment information for study equipment, it is the SPONSOR/CRO’s responsibility to approve and submit any updates to this document.

For added security, AiCure requires 1-3 individuals from the Sponsor/CRO team to be designated as an Authorized Requestor.

Authorized requestors are responsible for….

1. Maintaining the SUT for the study
2. Reviewing/approving any changes to the SUT
3. Submitting the SUT to AiCure for processing

AiCure will not accept SUT updates from a site or person who is not authorized. For updates or changes to the Authorized Requestor, the Sponsor/CRO must email the AiCure Project Manager for approval and processing.

 

NOTE: The format of the SUT document is not allowed to be edited without written permission from AiCure. Therefore, do not add/remove columns.

 

Format - High-Level Overview

Tab 1: Cover Page

• Study ID
• Includes list of Authorized Requestors.
• This tab will be locked for editing; the list of Authorized Requestors will be updated by AiCure after approval and processing.

 

Tab 2: Revision History

• Document each version and the date a new SUT was submitted to AiCure
• Include a brief description of the changes
• Responsibility of the Authorized Requestor to maintain this tab. AiCure will not make changes to this tab.

 

Tab 3: Site User Accounts

• Enter all site users on this tab who need access to the AiCure Site Dashboard.
• By default, everyone on this tab will receive Red Alert Emails.
• All columns are required for each user.
• If you select EDIT, please also highlight the cell you have edited (i.e. phone number). Please do not highlight the entire row unless each column is edited.
• If you REMOVE please also strikethrough the row data.
• For users that do not require a change, please update the action to NO CHANGE prior to re-submitting with other updates.

About ‘Column A: Actions’

Utilize the dropdowns in column A to indicate what action is needed.

IMPORTANT Actions from the previous submission MUST be cleared prior to re-submission. If you have submitted a user previously, please mark the row as ‘NO CHANGE’ for any subsequent re-submission.

 

Tab 4: Site Shipment & CRA Assignment

• For every site selected for the study, please enter the site information here.
• IMPORTANT: please also include the CRA NAME associated with each site. This is utilized for site outreach, escalations, and site reports.
• If you do not know the exact SIV date, entering the estimated SIV date is permissible. This will be utilized to coordinate shipping and CSS outreach/training.
• If you select EDIT, please also highlight the cell you have edited (i.e. phone number). Please do not highlight the entire row unless each column is edited.
• If you REMOVE, please also strikethrough the row data.
• For sites that do not require a change, please update the action to NO CHANGE prior to re-submitting with other updates.

IMPORTANT: Please do not forget to add the CRA assignment here!

 

Tab 5: Country Shipment

• If depots are being utilized for centralized country-level shipping of AiCure equipment (i.e. provisioned devices), this tab is required.
• Please capture all depot/country-level shipping information here.
• Include any special instructions in column F.

 

Tab 6: Sponsor/CRO User Accounts

• Include all Sponsor + CRO contact information here.
• Please include the country assignment in column G. AiCure will reference this column for escalations, shipping, and outreach.
• Please indicate which reports each user would like to receive in columns I and J.
• If you select EDIT, please also highlight the cell you have edited (i.e. phone number). Please do not highlight the entire row unless each column is edited.
• If you REMOVE please also strikethrough the row data.
• For sites that do not require a change, please update the action to NO CHANGE prior to re-submitting with other updates.

 

Tab 6: Sponsor + CRO Team - Access & Reports

In Columns I and J, please select “YES” or “NO” from the drop downs to indicate whether the user would like access to the following…

• AiCure Sponsor Dashboard - for on-demand access to study, country, site, and participant-level data.
• Sponsor Weekly Reports - Select yes if this user would like to receive the standard sponsor weekly reports including adherence, red alerts, provisioning, technical support, and site accounts.
• Receive Clinical Site Services (CSS) Reports - Select if this user would like to receive the weekly monitoring report from the CSS team.

 

Tab 7: Alpha-2 Code

• The Alpha-2 Code must be used for the country on the Site User Accounts Tab for processing.
• Tab 7 references the Alpha-2 Codes.

 

 

Formatting Requirements

If formatting requirements are not followed, your SUT submission will be rejected and not processed.

● Maintain one master SUT per study. Any and all updates should be made to the most recent SUT, and saved with a new date and new version number. Therefore, it is NOT permissible to submit one SUT per country or create a single SUT per site or per request.

• Save the SUT according to the following nomenclature, updating the date and the version number for each new submission.
       File Name:    •FORM-OPS-012-03 AiCure Site & User Tracker_(STUDY ID)_(DATE OF SUBMISSION)
• All fields on the SUT are required and must be completed for each user at the time of submission. The SUT Template may not be modified without written permission from AiCure; meaning addition or removal of columns is not permitted.
• For all users on any tab, use the dropdowns in ‘Column A: Action’ to indicate what change is needed for each entry.  A detailed description of the dropdowns & corresponding required actions is on slide 8.       
  • IMPORTANT Actions from the previous submission MUST be cleared prior to re-submission. If you have submitted a user previously, please mark the row as ‘NO CHANGE’ for any subsequent re-submission.
• For updates regarding site shipment information
  • If the exact SIV date is not known, it is permissible to use the best estimate of the SIV date, if the exact date is not known.
  • The shipping address must include street address, city, state, and zip code.
• Duplicate entries are not permitted. Please search for the user and update the existing entry instead of adding a duplicative row. 
• AiCure highly recommends the SUT is updated weekly and requires at minimum, an update each month.

 

Submission Process

Submit SUT to the AiCure Help Center

Access & Log In

• Navigate to the AiCure Help Center (support.aicure.com) and Login.
• Authorized Requestors must login.
• If you do not have a login, you can sign up with your email.

 

SUT Submission Form

• After you’ve logged in, select the ‘Submit Request’ button in the upper right-hand corner.
• From the dropdown menu, select ‘SUT Submission (Authorized Requestor Only)’

NOTE: Only authorized requestors will have access to this dropdown. If you (1 - 3 requestors permitted per study). If you have questions, please contact your AiCure Project Manager.

 

Fill out the SUT Submission Form

• Fill out the required fields, attach the updated SUT, and press Submit.
• Your AiCure Project Manager will automatically be notified of the new submission.
• You can track the status of your request under your AiCure Help Center account.
• The AiCure Technical Support team will email you once your request has been processed (typically within X business days)

 

 

 

 

Formatting Requirements