The Conduct of a Cooperative Clinical Trial

1 General Organization.- 1.1 Introduction and Objectives.- 1.2 General Organization.- 1.3 The Coordinating Center.- 1.4 The Statistical Center.- 2 Overview of Group Activities.- 2.1 Introduction.- 2.2 Protocol Generation.- 2.3 Forms Generation.- 2.4 Patient Entry.- 2.5 Data Flow.- 2.6 Form Submission.- 2.7 Completed Forms Review.- 2.8 Computerized Requests and Status Lists.- 2.9 Records Review.- 2.10 Biostatistical Reports.- 3 Institution Specific Activities.- 3.1 Institutional Data Management.- 3.2 Patient Entry.- 3.3 Forms Submission.- 3.4 Clarification Requests.- 3.5 Computerized Requests and Status Lists.- 4 Coordinating Center Specific Activities.- 4.1 The Administrative Office.- 4.2 Patient Entry.- 4.3 Blank Forms Distribution.- 4.4 Patient Files.- 4.5 Reception and Distribution of Forms.- 4.6 Mail Procedure to the Statistical Center.- 4.7 Clarification Requests.- 4.8 Computerized Requests and Study Status Lists.- 4.9 Records Review.- 4.10 Biostatistical Reports.- 4.11 Annual Meetings.- 5 Statistical Center Specific Activities.- 5.1 Mail Logging and Filing.- 5.2 General Forms Review.- 5.3 Coding Conventions.- 5.4 Review of Specific Forms.- 5.5 File Organization.- 5.6 File Maintenance.- 5.6.3 Update Program.- 5.7 Data Retrieval.- 5.8 Computer Listings.- 5.9 Manuals.- 5.10 Workshops.- Appendix 1. Protocol.- Appendix 2. Forms.- Appendix 3. Example of Data Request.- Appendix 4. Example of Patient Listing.- Appendix 5. Participant Forms Submission Log.- Appendix 6. Operations Office Patient Log.- Appendix 7. Sample Page of Randomization List.- Appendix 8. Sample Data File.- Appendix 9. Statistical Center Forms Log.- Appendix 10. Example of an Interim Statistical Analysis.- Appendix 11. Terminology.