*Protocol Deviation Codes: A Consent Procedures – B Inclusion/Exclusion Criteria – C Concomitant Medication/Therapy – D Laboratory Assessments/Procedures – E Study Procedures – F Serious Adverse Event Reporting/Unanticipated Adverse Device Effect – G Randomisation Procedures/Study Drug Dosing – H Visit Schedule/Interval – I Efficacy Ratings – J Other –
*Protocol Deviation Codes: A – Consent Procedures B – Inclusion/Exclusion Criteria C – Concomitant Medication/Therapy D – Laboratory Assessments/Procedures E – Study Procedures F – Serious Adverse Event Reporting/Unanticipated Adverse Device Effect G – Randomisation Procedures/Study Drug Dosing H – Visit Schedule/Interval I – Efficacy Ratings J – Other
2017.09.18_Protocol_Deviation_Tracking_Log_ver2.docx