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

Review Concomitant Medications during re-consent

It is crucial PIs discuss the importance of gathering accurate concomitant medication during upcoming participant re-consents. Specifically, the dangers of 'double dipping' with additional weight loss medications while on the VANQUISH program should be stressed to participants. 

If your site has any questions regarding concomitant medications that may lead to additional weight loss while on IP, please do not hesitate to reach out to your site’s CRA or Medpace Medical Monitors.  

Autoinjectors

Malfunction

In cases of autoinjectors malfunction following administration, please first complete the autoinjector complaint form located in the pharmacy manual, then destroy the autoinjector per your site’s process.  

In cases of autoinjectors malfunction prior to administration, please first complete the autoinjector complaint form located in the pharmacy manual, then return the autoinjector per your site’s process.  

Participant Travel

If participants need to travel with their autoinjectors, PIs should provide documentation to their participants to support travel. Medpace would recommend a PI note, potentially review country regulations on travel requirements, and provide a Patient Emergency card.  

Injection Site Rotation

Per protocol participants should be trained to rotate the location of the injection site as is done during the weekly clinic visits.  

When reviewing IP compliance with participants please ensure you are reminding them of the need to rotate the injection site location, documenting this review in source and completing retraining should the participant be injecting in the same location back to back weeks.  

Update ePRO app

Please be advised ePRO updated their app recently. Participants should be instructed to update the app at their next study visit.  

Friendly reminder the ePRO help desk is for sites ONLY. Participants should not be using nor be referenced to the help desk.  

Malnutrition Assessment Updates

When reviewing malnourishment assessment results, sites should review lab reports issued daily, but a full assessment should be made when all malnutrition results are available. Please follow the below instructions to review cumulative data in ClinTrak lab for malnourishment assessment visits.  

Navigate to ClinTrak Lab -> Lab Reports & Flags -> Cumulative. Select Site/Subject and leave Panel as All. -> Apply Filter  

• A table will populate all testing completed in order of date. To review malnourishment assessment testing, refer to the UMAL columns of testing.  This table can be exported to PDF or Excel formats.  

PI Drop-In Session Q&A Log

Please see a previous email for the Q&A log from our PI and medical monitoring drop-in calls. If further clarification is needed, please reach out to the medical monitoring team or your CRA.  

Updated eCRF Completion Guidelines

Please refer to a previous email for the updated V3.0 of the eCCGs. Please review and file to your site’s ISF.  

Site Hub Log In

This website acts as a helpful tool to reference common site questions, important study contacts and weekly study updates. If you have trouble accessing your account, or if you have any questions regarding the site hub please reach out to Cooper Cadman at c.cadman1@medpace.com

Be sure to login frequently to stay up to date on all aspects of the Vanquish-1 study.