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.- 3.3.1 Clinical and Preoperative Form B.- 3.3.2 Surgery Form C.- 3.3.3 Histology and Study Treatment Form D.- 3.3.4 Follow-up Form E.- 3.3.5 Flow Sheet Form F.- 3.3.6 Death Report.- 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.- 4.2.1 Material.- 4.2.2 The Randomization Procedure.- 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.- 5.2.1 General Rules.- 5.2.2 Query Letters.- 5.2.3 Comment Records.- 5.2.4 Problems.- 5.3 Coding Conventions.- 5.4 Review of Specific Forms.- 5.4.1 Confirmation of Registration Form (Form A).- 5.4.2 Clinical and Preoperative Form (Form B).- 5.4.3 Surgery Form (Form C).- 5.4.4 Histology and Study Treatment Form (Form D).- 5.4.5 Follow-up Form (Form E).- 5.4.6 Flow Sheet Form (Form F).- 5.4.7 Eligibility Review Forms (Forms V1 and V2).- 5.5 File Organization.- 5.6 File Maintenance.- 5.6.1 Keypunch.- 5.6.2 Datapoint.- 5.6.3 Update Program.- 5.7 Data Retrieval.- 5.8 Computer Listings.- 5.8.1 Patient Listings.- 5.8.2 Data Request.- 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.