Are self-reported cough scale scores via the eDiaries available for review in real-time for eligibility purposes?
Sites are not able to view the subject’s responses to the cough scales. Monitors and the Sponsor/CRO clinical team will not be able to view the responses either. This design is best practise to avoid any influence over the subject’s scores. Eligibility will only be confirmed when the subject comes to the site for Visit 2 (Baseline). It will however be possible to review subject compliance via Study Manager so that site staff can follow-up with subjects that may be forgetting or having any issues with diary completion.