A MANAGER’S GUIDE TO THE DESIGN AND CONDUCT OF CLINICAL TRIALS - PART 9 doc
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 ... http://www.consort-statement.org/. See also the AMA Manual of Style ( 199 4), Bailar and Mosteller ( 198 8), and Long and Secic ( 199 7). POSTMARKET SURVEILLANCE Ours...
Ngày tải lên: 14/08/2014, 07:20
A MANAGER’S GUIDE TO THE DESIGN AND CONDUCT OF CLINICAL TRIALS - PART 1 ppsx
... Form 94 Procedures Manuals 95 Physician’s Procedures Manual 96 Laboratory Guidelines 97 Interim Reports 97 Enrollment Report 98 Data in Hand 98 Adverse Event Report 99 Annotated Abstract 99 Final ... 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 fr...
Ngày tải lên: 14/08/2014, 07:20
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...
Ngày tải lên: 14/08/2014, 07:20
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...
Ngày tải lên: 14/08/2014, 07:20
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...
Ngày tải lên: 14/08/2014, 07:20
A MANAGER’S GUIDE TO THE DESIGN AND CONDUCT OF CLINICAL TRIALS - PART 5 potx
... weeks. CANDAs eliminate much of this delay. By employing computer-assisted data entry you are automatically in a position to submit a CANDA. Between 199 1 and 199 4, CANDAs in the United States were approved ... comprehensive as those provided to the physi- cian. They should cover the preparation of the sample, shipping and receiving, and the particulars of the...
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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 databa...
Ngày tải lên: 14/08/2014, 07:20
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 ... to use the patient ID as a primary key to tie all the databases together and to use an examination date or some other value as a secondary key to tie together info...
Ngày tải lên: 14/08/2014, 07:20
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 ... in the analysis of clinical trials. 4. Familiarity. Too often, the choice of statistical method is determined on the basis of the technique that was used in...
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A MANAGER’S GUIDE TO THE DESIGN AND CONDUCT OF CLINICAL TRIALS - PART 10 potx
... CA 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 ... CHECK Appendix Software APPENDIX SOFTWARE 237 Let the software determine your hardware. Good ( 198 4) An extremely wide choice of software is available to ease your tas...
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- verilog a guide to digital design and synthesis
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