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