CLINICAL TRIAL PROTOCOL SPACE 2 Stent ... - SPACE-2 Studie

Clinical Trial Code: SPACE 2 Version: 10. October 2008 Final
9.2 Analysis variables 30
9.3 Definition of trial population to be analyzed 30
9.4 Statistical methods 31
9.5 Interim analyses 31
10 Study administration 32
10.1 Data Safety and Monitoring Board (DSMB) 33
10.2 Steering Committee (SC) and Executive Committee (ExC) 34
10.3 Endpoint Evaluation committee (EEC) 36
10.4 Quality Subcommittees 37
10.5 Control of treatment quality 40
10.5.1 Centers 40
10.5.2 Investigators 40
10.6 Participating sites 40
11 Ethical and Legal Aspects 41
11.1 Good Clinical Practice 41
11.2 Subject information and informed consent 41
11.3 Confidentiality 41
11.4 Responsibilities of investigator 42
11.5 Approval of trial protocol and amendments 42
11.6 Continuous information to independent ethics committee 42
11.7 Registraton of the trial 43
12 Quality Assurance 43
12.1 Monitoring 43
12.2 Inspections / Audits 43
13 Agreements 44
13.1 Financing of the trial 44
13.2 Publication 44
14 Signatures 45
15 Declaration of Investigator 46
16 References 47
17 Appendices 49
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