A MANAGER’S GUIDE TO THE DESIGN AND CONDUCT OF CLINICAL TRIALS - PART 5 potx
A MANAGER’S GUIDE TO THE DESIGN AND CONDUCT OF CLINICAL TRIALS - PART 5 potx
... conditions worldwide in a well-organized and easy -to- reference format. Detailed profile information is provided for each drug. A Manager’s Guide to the Design and Conduct of Clinical Trials, by Phillip ... academic area, and industry collection forms can range from 50 to 200 pages per patient, in contrast to the 5- to 1 0- page forms of the typic...
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A MANAGER’S GUIDE TO THE DESIGN AND CONDUCT OF CLINICAL TRIALS - PART 4 potx
... format and organization of reports, for the format and contents of tables, and for the format and naming of files and directories. The CTD provides for analysis of trial data, descriptions of manu- facturing ... design one has to be able to assume that the effect of Treatment A is the same at all levels of the cofactor and in all subgroups. Again...
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A MANAGER’S GUIDE TO THE DESIGN AND CONDUCT OF CLINICAL TRIALS - PART 10 potx
... 155 storage, 133, 156 transfer, 154 types of, 64, 190 visualization, 181 Database management systems (DBMS), 150 Database manager, 30, 156 Database access, 148, 155 backup, 158 combining, 151 protection, ... 9 456 8. 1-8 0 0-8 SYBASE. C-ISAM. Although not a relational database, you don’t have to sift through records to get to the data you want. B+ tree index architec-...
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A MANAGER’S GUIDE TO THE DESIGN AND CONDUCT OF CLINICAL TRIALS - PART 1 ppsx
... data management and David Salsburg. fying the transnational submission process. The single set of standards makes it easier than ever to plan and coordinate your trials. And the transnational approach ... Assurance and Security 155 Maintaining Patient Confidentiality 155 Access to Files 155 Maintaining an Audit Trail 157 Security 157 For Further Information 158 12 Ar...
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A MANAGER’S GUIDE TO THE DESIGN AND CONDUCT OF CLINICAL TRIALS - PART 2 pps
... beyond an understanding of the data management software to security (main- taining onsite and offsite backups) and quality control. Programs for Data Analysis Development of programs for data analysis ... screens Database Manager 1 Integrity and security of data To say nothing of investigators, investigational laboratories, safety and efficacy review committees, and pat...
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A MANAGER’S GUIDE TO THE DESIGN AND CONDUCT OF CLINICAL TRIALS - PART 3 pps
... for monitoring and maintaining the quality of the data • Determined the necessary sample size and other aspects of the experimental design (See Chapter 6.) 50 PART I PLAN data gathered at the first ... out that train- ing and supervision of data managers, precision in writing protocols, standardization of the data entry process, and the use of a checklist...
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A MANAGER’S GUIDE TO THE DESIGN AND CONDUCT OF CLINICAL TRIALS - PART 6 pdf
... quickly? Hierarchical Databases The traditional answer to some of these issues was the hierarchical database model. A hierarchical database is a series of flat files, each one similar to a spreadsheet, that ... 11.9 The structural flexibility of a relational database allows combina- tions of data to be retrieved that were never anticipated at the time the database...
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A MANAGER’S GUIDE TO THE DESIGN AND CONDUCT OF CLINICAL TRIALS - PART 7 pot
... network the data that really matter. Microsoft’s PC-based Access®is a relational data- base, but it is not a database server. MS-SQL, SQL Anywhere®, DB2®, and Oracle®are both relational databases and ... error lay in setting up the data- base. Each of the case report forms was split into a half-dozen parts: investigator’s signature and date to one file and the dates...
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A MANAGER’S GUIDE TO THE DESIGN AND CONDUCT OF CLINICAL TRIALS - PART 8 pot
... of Table 15. 5 reveals the statistically significant relation of survival to the Karnofsky Index, which is a measure of the overall status of the cancer patient at the time of entry into the clinical ... purpose of the statistical analysis section of the final report like that of the final report itself is tell a story in as clear and concise a fashi...
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A MANAGER’S GUIDE TO THE DESIGN AND CONDUCT OF CLINICAL TRIALS - PART 9 doc
... unexpected factors in a trial’s outcome includ- ing gender. A further examination of the data reveals that the 16 female patients treated with the standard therapy and the adjunct all 216 PART II ... variables may be subject to variation, ordinary least- CHAPTER 15 DATA ANALYSIS 213 STATISTIC CHECK LIST Is the method appropriate to the type of data being analyzed?...
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