A MANAGER’S GUIDE TO THE DESIGN AND CONDUCT OF CLINICAL TRIALS - PART 6 pdf
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 1 ppsx
... data entry facilitates monitoring and allows you to stay on top of problems. Once the data are in the computer, they can be collated back at your facility with data from other patients and examined ... Bumbling Pharmaceutical and Device Company told in the chapters that follow is too often the case in all too many clinical studies. The high price of pharmaceuticals tod...
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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 checklis...
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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 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 ... weeks. CANDAs eliminate much of this delay. By employing computer-assisted data entry you are automatically in a position to submit a CANDA. Between 1991...
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A MANAGER’S GUIDE TO THE DESIGN AND CONDUCT OF CLINICAL TRIALS - PART 7 pot
... investigator to central storage • Transfer of samples from investigator to external laboratory and of data from external laboratory to central storage • Physician and laboratory manuals • Recruitment ... day 4, the backup of day 4 is sent to a remote location and the cycle is restarted; the backups of days 2 and 3 are discarded as days 5 and 6 backed up. Al...
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A MANAGER’S GUIDE TO THE DESIGN AND CONDUCT OF CLINICAL TRIALS - PART 8 pot
... of the eligibility criteria, the proportion of males and females, average age of the par- ticipants and so forth. For categorical variables such as sex and race, report both the percentages and ... for the Format and Content of the Clinical and Statistical Sections of an Application may be downloaded from http://www.fda.gov/cder/guidance/statnda .pdf. The...
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A MANAGER’S GUIDE TO THE DESIGN AND CONDUCT OF CLINICAL TRIALS - PART 9 doc
... from the sample in hand to a larger popula- tion, the samples must be taken at random from and be representa- tive of that population. 48 An examination of surgical procedures and of those characteristics which ... percentage, and type of adverse events associ- ated with each treatment. Accompany this tabulation with a statistical analysis of the set of adverse e...
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A MANAGER’S GUIDE TO THE DESIGN AND CONDUCT OF CLINICAL TRIALS - PART 10 potx
... 94 568 . 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- ture makes data retrieval fast and ... in medical journals. Amplifications and explanations. Ann Intern Med 108: 266 –273. Barnard GA. (1990) Must clinical trials be large? The interpretation of p- values a...
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