Standard Operating Procedures for Clinical Trials of the Central European Society for Anticancer Drug Research (Cesar-Ewiv (Supplement Issue: Onkologie 2003, 6)

Contents......Page 3
Inventories......Page 5
Authors......Page 6
Glossary......Page 7
Preface......Page 8
Becoming a Member of a the WorkingGroup(s) of CESAR......Page 9
Appendix......Page 10
Evaluation Process......Page 13
Appendix......Page 14
Structure of a Trial Protocol......Page 19
Appendix......Page 21
General Remarks on Case Report Form Handling......Page 23
Appendix......Page 24
Elements of Information to Patients......Page 31
Appendix......Page 32
Exclusion from an Ongoing Study......Page 42
Study Activation......Page 43
Trial Documentation......Page 44
References......Page 45
Activities before a Trial Initiation Visit......Page 46
Activities during a Monitoring Visit......Page 47
Activities Following a Closeout Visit......Page 48
Immediate Reporting of Serious or Unexpected Adverse Events......Page 49
References......Page 50
Statistical Study Design......Page 51
Statistical Analysis......Page 52
References......Page 55
Authorship for Publications......Page 56
Press Release and Information to the Public......Page 57
System Audits of CESAR......Page 58
Study Evaluation Meetings/Response Evaluation Meetings......Page 59
Validation Parameters......Page 60
Routine Drug Analysis......Page 61
Documentation and Archiving of Analytical Data......Page 62
References......Page 63
Study Considerations......Page 64
Compartmental Data Analysis......Page 65
Population Pharmacokinetic Data Analysis......Page 66
References......Page 67
Study Design and Execution......Page 68
Graphical Analysis......Page 69
Basic Model......Page 70
Goodness of Fit......Page 72
References......Page 73