HiLIT is an electronic adverse event reporting system housed on the DMID-CROMS website which allows clinical sites to submit adverse events directly to DMID-CROMS PVG.

If your site utilizes HiLIT to submit adverse events to DMID-CROMS PVG for a protocol, access to the HiLIT system can be initiated through the following steps:

• Go to www.dmidcroms.com and submit a Systems Access Request Form (SARF) for HiLIT System access. Please check HiLIT as the “Product” and provide your name, site role, email address, and phone number. Please specify your site name and protocol number(s) in the “Specify Request Details” box.
• Helpdesk will email you instructions to access the HiLIT System Training.
• Complete HiLIT System Training.
• Once training is completed, Helpdesk will email you instructions to access the HiLIT System.

There are 3 steps that a site must perform in HiLIT to successfully submit an adverse event:

• Data Entry - a site staff member enters adverse event data into HiLIT and routes the adverse event to an authorized* staff member for Quality Control (QC).
• Quality Control (QC) - an authorized* staff member reviews the adverse event for completion and correctness.
• Submission - once the adverse event is approved for submission, the authorized* staff member submits the adverse event to DMID-CROMS PVG.

*Note: All adverse events submitted to DMID-CROMS PVG must be reviewed and submitted to DMID-CROMS PVG by an authorized Study Investigator or Sub-Investigator listed on Form 1572.

Instructions for submitting adverse events to DMID-CROMS PVG using HiLIT can be found here: HiLIT QuickStart Guide

For additional questions regarding case processing and adverse event submission, please contact PVG@dmidcroms.com.

For technical assistance, please contact helpdesk@tech-res.com.

Once data entry is complete, the case must be routed for QC per the following steps:

• Click the Route button.

 

• Select an authorized Study Investigator listed on Form 1572 from the drop-down list (the safety event can also be self-assigned for QC). Click Proceed.

 

• Take note of the displayed HiLIT Case ID number and confirmation of successful case routing. Click OK.

 

• The case will appear in the Pending tab of the dashboard/Home screen.

 

• From the Pending tab on the HiLIT dashboard, click Review ( ) for safety event in QC Pending status.

 

• Review the safety event and make edits as needed. Click Save.

 

• Once the case has been reviewed and is approved for submission to DMID-CROMS PVG, click Route, and then Submit, and then Proceed.
  
• A pop-up box will appear confirming successful submission. Click OK.

 

• The case will appear on the All tab of the dashboard/Home screen with Pending Acceptance status.

 

Completed cases can be printed to include in the site regulatory file using the following steps:

• From the dashboard (Home) Completed tab, select the desired request with the E2B Status (). Please ensure that a correct date range is selected to view the desired request.

 

• Point to the right end of the selected row, and then click the View Request icon ().

 

• Click the Attachments icon () in the navigation pane to view the Attachments section.

 

• Locate the desired attachment that begins with SNP-Request ID:

 

• Point to the right end of the attachment row, and then click the View icon ().
  

 

• The information that was submitted to DMID-CROMS PVG will appear. Click the Print icon () shown at the top of the Attachment view to print a hardcopy of the request. To save a copy of the report as a PDF to your local drive, click the Download icon ().