Thank you for all your efforts on this study so far! 

Study Reminders

VANQUISH 301/302 Dose Dispensing Worksheet

• To support quality and consistency for dosing completion, the Dose Dispensing Worksheet (previously attached via email) has been developed for site use. This worksheet can be used as a tool to support focus and attention when completing dosing visits for your enrolled subjects.

Temperature Excursion Reporting Reminders

• Please ensure you are following the requirements of the Pharmacy Manual when reporting temperature excursions for review. The Temperature Excursion Reporting Form was attached via email for quick reference.

Update on Hypoglycemia Symptoms Diary and SMBG Data Reports  

• All ePRO reported data is available in ClinTrak for site users to review and reference in real time. The study team will no longer distribute to you weekly as all items are available for you within ClinTrak EDC. Please see the details below to support your team in obtaining the data.  

• Hypoglycemia Symptoms Diary Patient Report

• To review subjects Hypoglycemia Symptoms Diary responses, a report is available within ClinTrak EDC for easy review. When you log in to ClinTrak EDC and select the “Data Entry” tab and your site number (circled in yellow), there will be a report titled “Hypo Diary” on the “Study Information” screen. This screen often auto populates upon selection.  The “Hypo Diary” report can be exported in a CSV or PDF file (circled in red) for easy review and sorting. Scrolling may be required to view all subject entered responses.  

• The Hypo Diaries can also be sorted within ClinTrak EDC by clicking on the up and down arrows at the top of each column. This will allow you to sort from highest to lowest without exporting the diaries to your computer.  

• SMBG Diary Patient Report

• To review subjects SMBG Diary responses, a report is available within ClinTrak EDC for easy review. When you log in to ClinTrak EDC and select the “Data Entry” tab and your site number (circled in yellow),then select the desired subject, there will be a report titled “SMBG” on the screen. This screen often auto populates upon selection.  The “SMBG” report can be exported in a CSV or PDF file for easy review and sorting. Scrolling may be required to view all subject entered responses.  

• The SMBG can also be sorted within ClinTrak EDC by clicking on the up and down arrows at the top of each column. This will allow you to sort from highest to lowest without exporting the diaries to your computer.  

If there are any further questions, please reach out to your CRA or ePROhelp@medpace.com  

MRL Reminder

• When responding to MRL queries, please do not include the subject's full date of birth. Only the year of birth and age is required to resolve the query. Our data management team is not able to save responses for record when it contains protected health information. Please reach out to the MRL PM team with any further questions. 

Autoinjector  

• Please be advised, as sites transition subjects to autoinjectors, IRT will begin to dispense on a 30-day supply strategy. This will result in sites receiving IP on a once-a-week basis.