Euro Ewing 2012 Protocol
Euro Ewing 2012 protocol_version 5.0_2-Jun-2017
CRCTU-PRT-QCD-001, version 1.0
10.1.3 Reporting period ................................................................................................................ 57
10.1.4 Post study SARs and SUSARs: ........................................................................................ 57
10.2 Reporting Procedure ............................................................................................................. 57
10.2.1 Site ..................................................................................................................................... 57
10.2.2 UK Coordinating Centre .................................................................................................... 58
10.2.3 Reporting to the Competent Authority and Research Ethics Committee .......................... 58
10.2.4 Investigators ...................................................................................................................... 59
10.2.5 Data Monitoring Committee ............................................................................................... 59
11. Data Handling and Record Keeping ............................................................................................. 60
11.1 Data Collection ...................................................................................................................... 60
11.2 Archiving ................................................................................................................................ 60
12. Quality Management ...................................................................................................................... 60
12.1 Site Set-up and Initiation ....................................................................................................... 60
12.2 On-site Monitoring ................................................................................................................. 61
12.3 Central Monitoring ................................................................................................................. 61
12.4 Audit and Inspection .............................................................................................................. 61
12.5 Notification of Serious Breaches ........................................................................................... 61
13. End of Trial Definition .................................................................................................................... 62
14. Statistical Considerations ............................................................................................................. 62
14.1 Definition of Outcome Measures ........................................................................................... 62
14.1.1 Primary outcome measure ................................................................................................ 62
14.1.2 Secondary outcome measures .......................................................................................... 62
14.2 Induction/consolidation chemotherapy randomisation: general principles ............................ 63
14.3 Sample Size Calculations ...................................................................................................... 64
14.3.1 Induction/consolidation randomisation (R1) ...................................................................... 64
14.3.2 Zoledronic acid randomisation (R2)................................................................................... 65
14.4 Analysis of Outcome Measures ............................................................................................. 66
14.5 Planned Subgroup Analyses ................................................................................................. 68
14.6 Planned Interim Analysis ....................................................................................................... 68
14.7 Planned Main Analyses ......................................................................................................... 68
15. Trial Organisational Structure ....................................................................................................... 68
15.1 Coordinating-sponsor ............................................................................................................ 69
15.2 National Coordinating Centres .............................................................................................. 69
15.3 Trial Management Group ....................................................................................................... 69
15.4 Trial Steering Committee ....................................................................................................... 69
15.5 Data Monitoring Committee ................................................................................................... 69
15.6 Finance .................................................................................................................................. 70
16. Ethical Considerations .................................................................................................................. 70
17. Confidentiality and Data Protection ............................................................................................. 71
18. Insurance and Indemnity ............................................................................................................... 71
19. Publication Policy .......................................................................................................................... 71
20. Reference List ................................................................................................................................. 73
Appendix 1 – United Kingdom Specific Quality and Trial management Plan ............................... 76
Records of Screening/enrolment ....................................................................................................... 76
Informed Consent Form Review ........................................................................................................ 76
Site Set-up and Initiation .................................................................................................................... 76
Pharmacy ........................................................................................................................................... 76
On-site Monitoring .............................................................................................................................. 76