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

IRT Dispensation Guidance for Participants Who Return for Weekly Injection Between Monthly Visits

Per protocol participants can complete weekly visits during Part B if the participant is uncomfortable with completing injections.  

IRT Action

• At the monthly visit, sites should use the “Record a Monthly Visit” action and enter 1 Autoinjector instead of 4 in the Quantity of Autoinjectors to Assign field. Example:

• At the visits between the monthly visit, site should use the “Record Unscheduled Autoinjector Assignment (Part B Participants Only)” action and enter 1 Autoinjector instead of 4 in the Quantity of Autoinjectors to Assign field. Example:

EDC  

• At the monthly visit, record all data as collected. Under the Exposure eCRF “Were autoinjectors assigned at this visit to be used in weeks leading up to the next visit?” response should be “No”.

• At the visits between the monthly visit, record each autoinjector administered under its own unscheduled visit and exposure form in EDC.  

Data Entry Reminders  

Reconsent eCRF is only to be completed once per protocol amendment, if multiple were added, please remove/refrain from entering. 

Drug Accountability eCRFs please ensure to enter all applicable auto injector IDs dispensed to the participant to take home should be recorded under the applicable study visit folder. 

• In addition, remember you will be required to go back to that visit when the autoinjectors are returned and to update accordingly. 

Pharmacy Manual V6.0 - Temperature Excursion Form & Malfunction Form

Please review the updated Pharmacy Manual (previously distributed via email) for guidance regarding autoinjector return (section 5.5 Destruction/Return of IP), new stability information, an updated Temperature Excursion form, and new autoinjector return request form for malfunctioning autoinjectors.  

• File is your site’s ISF. If you have any further questions, please reach out to your site’s assigned CRA.