74 7.5 Procedures to be followed in the event of abnormal laboratory test values .............. 74 7.6 Overdosing with the trial medication ........................................................................ 74 8. RESPONSIBILITIES OF THE INVESTIGATORS ............................................................... 75 8.1 Patient i nformation .................................................................................................... 75 8.2 Patient consent ........................................................................................................... 77 8.3 Ethics review ............................................................................................................. 77 8.4 Source data and patient files ...................................................................................... 77 8.5 Training of staff ......................................................................................................... 78 8.6 Trial agreements ........................................................................................................ 78 8.7 Confidentiality ........................................................................................................... 78 9. TRIAL MANAGEMENT ........................................................................................................ 78 9.1 Monitoring ................................................................................................................. 78 9.2 Audits and inspections ............................................................................................... 79 9.3 Case report form handling ......................................................................................... 79 9.4 Amen dments to the trial protocol .............................................................................. 79 9.5 Deviations from the trial protocol ............................................................................. 80 9.6 Trial report and publication policy ............................................................................ 80 9.7 Volume of blood sampling and handling of biological samples ............................... 80 CT TG01 -01 Version v10.0 27 June 2018 Confidential 5 / 87 10.