WA29249 Stretto StudyInvestigator Portal 19th March

Questions for Discussion Are you happy to show site recruitment metrics on the map - i.e ahead of plan, on target, behind scheduleRoche responsibility for supplying weekly?

Priority of tasks for Investigators - should there be a hierarchy? e-learning, patient screening to review, outstanding training module

Points to NoteGCP (Accelerate) Module - will ask if you have previously completed this elearning module. If yes, add date of completion. This action will override system and mark your module as complete.

IVRS (ClinPhone) Module - The training is given at the IM, so anyone who attended that is exempt from having to complete this. Filter question will ask if they attended the training session at IM or not. If yes, they will confirm the date they attended and a certificate will be generated. If no, they will do the module

Spirometry (Vitograph) Modules - Spirometry specialsits can only see their modules, can't be allowed to see ePRO technician modules and vice versa.

Integration with Perceptive IVRS (ClinPhone)At this stage ClinPhone integration with another system is not possible. Also Investigators will be logging informed consent and randomization on the ClinPhone system, so they won't do this again on the ClinPal system. Proposed solution is for invite to screening to be logged on ClinPal, then a link to the IVRS system to log consent and randomization, then a link back to ClinPal where they will be asked if this patient was succesfully randomized.

Questions for Discussion Roles & Responsibilities can only the Investigator review patient screening submission from recruitment website?I.e. can this be delegated to a study nurse?