The conduct of a cooperative clinical trial
著者
書誌事項
The conduct of a cooperative clinical trial
（Recent results in cancer research, 77）
Springer-Verlag, 1981
- : pbk
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注記
Bibliography: p. 37
Includes index
内容説明・目次
- 巻冊次
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ISBN 9783540106807
内容説明
The purpose of this monograph is to address the basic mecha- nisms for organizing trials. Is is meant to serve as a guide to individuals planning to form a cooperative group as well as to cooperative groups who wish to revise and refine their existing procedures. Current literature deals with many components of conducting clinical trials, such as trial design considerations, randomization, and methods of analysis. But there is a lack of accessible knowledge concerning data flow, data processing, and group organization which causes difficulty for many multi- institutional cooperative trials. Multi-institutional cooperative studies require greater atten- tion to detail than studies within a single institution. For single institution studies, a single protocol document may be suffi- cient. In a cooperative group, however, it is necessary to standardize various aspects where little variation may be pre- sent in a single institution study. Patients must be entered in a uniform fashion, data collection and evaluation should be standardized, and there must be a mechanism to insure the timely collection of essential data.
目次
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.
- 巻冊次
-
: pbk ISBN 9783642816321
内容説明
The purpose of this monograph is to address the basic mecha nisms for organizing trials. Is is meant to serve as a guide to individuals planning to form a cooperative group as well as to cooperative groups who wish to revise and refine their existing procedures. Current literature deals with many components of conducting clinical trials, such as trial design considerations, randomization, and methods of analysis. But there is a lack of accessible knowledge concerning data flow, data processing, and group organization which causes difficulty for many multi institutional cooperative trials. Multi-institutional cooperative studies require greater atten tion to detail than studies within a single institution. For single institution studies, a single protocol document may be suffi cient. In a cooperative group, however, it is necessary to standardize various aspects where little variation may be pre sent in a single institution study. Patients must be entered in a uniform fashion, data collection and evaluation should be standardized, and there must be a mechanism to insure the timely collection of essential data.
目次
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.
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