Protocol Deviation Form Participant ID(Required) Product Number / Screening Number(Required) Trial Coordinator Completing this Form(Required) Date that deviation became known(Required) MM slash DD slash YYYY Category(Required) Informed Consent Inclusion/Exclusion Criteria Investigational Product (incorrect or missed dose, storage etc) Prohibited Concomitant Medicine / Procedure Trial Procedures (missed/out of window visit or procedure/questionnaire etc) Other Description of Deviation (including date/s of occurrence)(Required)Can participant continue on Study?(Required) Yes - Continuing on Study No - Withdrawing from Study Unknown - PI input required
