A MANAGER’S GUIDE TO THE DESIGN AND CONDUCT OF CLINICAL TRIALS - PART 1 ppsx
A MANAGER’S GUIDE TO THE DESIGN AND CONDUCT OF CLINICAL TRIALS - PART 1 ppsx
... Multiple Databases 15 1 A Recipe for Disaster 15 2Transferring Data 15 4Quality Assurance and Security 15 5Maintaining Patient Confidentiality 15 5Access to Files 15 5Maintaining an Audit Trail 15 7Security ... 18 4Extending the Trials 18 6Budgets and Expenditures 18 6For Further Information 18 7 15 Data Analysis 18 9Report Coverage 18 9Understanding Data 19 0Categories 19 0Metric Data 19 2Statistical ... 15 7Security 15 7For Further Information 15 8 12 Are You Ready? 16 1Pharmaceuticals/Devices 16 1Software 16 2Hardware 16 2Documentation 16 2Investigators 16 2External Laboratories 16 3Review Committees 16 3Patients...
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A MANAGER’S GUIDE TO THE DESIGN AND CONDUCT OF CLINICAL TRIALS - PART 2 pps
... beyond anunderstanding of the data management software to security (main-taining onsite and offsite backups) and quality control.Programs for Data AnalysisDevelopment of programs for data analysis ... screensDatabase Manager 1 Integrity and security of data To say nothing of investigators, investigational laboratories, safety and efficacyreview committees, and patients.32 PART I PLAN 13 Don’t attribute ... divided among the lead software engineer, the data manager, and the statistician(subject, of course, to corporate approval, a topic on which we waxapoplectic in Chapter 10 ). The project leader may...
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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 PLANdata 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 checklistfor therapy data and treatment toxicities ... you to undertake a set of near-duplicate trials at a later date. Too broad a claim may result in with-drawal of the petition for regulatory approval simply because the treatment/device is inappropriate...
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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 alllevels of the cofactor and in all subgroups. Again, these assumptionsare seldom realized in practice and represent ... Introduction2.2NonclinicalOverview2.4 Clinical Overview2.5 Clinical Summary2.7QualityOverallSummary2.3Nonclinical Written and TabulatedSummaries2.6FIGURE 8 .1 and a manual of the procedures that are to be followed in gathering and evaluating...
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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 automaticallyin a position to submit a CANDA.Between 19 91 and 19 94, CANDAs in the United States wereapproved ... the 5- to 10 -page protocolscommon in the academic area, and industry collection forms canrange from 50 to 200 pages per patient, in contrast to the 5- to 1 0- page forms of the typical academic ... specifically to conduct clinical trials. An annotated CHAPTER 9 RECRUITING AND RETAINING PATIENTS AND PHYSICIANS 10 9“Thirteen leading medical journals willtoday warn that the promise of financialrewards...
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A MANAGER’S GUIDE TO THE DESIGN AND CONDUCT OF CLINICAL TRIALS - PART 6 pdf
... to you2. Transfer of data from data entry to data storage and from datastorage to your report generating and statistical analysis software3. Maintaining the security and integrity of your dataOPTIONSFlat ... quickly?Hierarchical Databases The traditional answer to some of these issues was the hierarchicaldatabase model. A hierarchical database is a series of flat files, eachone similar to a spreadsheet, that ... 248 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 was designed. In contrast, the database...
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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 ... Project manager, software manager, and datamanager. Cross-functional review and approval by biostatistics, CRMs, and medical affairs.Instruction manuals Design team, medical manager, and medicalwriting ... second and incurable 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 of variousevents...
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A MANAGER’S GUIDE TO THE DESIGN AND CONDUCT OF CLINICAL TRIALS - PART 8 pot
... 28 019 217 911 4 015 10 2 26 2 27 11 0 19 2 18 12 0 12 1 11 13 0 24 5 19 14 2 10 2 11 15 0 14 11 3 16 0 53 4 48 19 1 50 1 4820 0 13 1 13 21 0 13 1 13will have no reason to believe the two treatments have ... of the eligibilitycriteria, 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 ... unre-lated to treatment. 19 4 PART II DOAt first glance, it would seem that sta-tistics as a branch of mathematicsought to be an exact science and the choice of the correct statistical proce-dure...
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A MANAGER’S GUIDE TO THE DESIGN AND CONDUCT OF CLINICAL TRIALS - PART 9 doc
... this: 13 8.5 13 8.5 14 0.0 14 1.0 14 1.0 14 3.5 14 5.0 14 7.0 14 8.5 15 0.0 15 3.0 15 4.0 15 5.0 15 6.5 15 7.0 15 8.5 15 9.0 15 9.0 15 9.0 16 0.5 16 1.0 16 2.Several of the values have been repeated as we are sampling ... 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 besubject to variation, ordinary least-CHAPTER 15 DATA ANALYSIS 213 STATISTIC CHECK LISTIs the method appropriate to the type of data being analyzed?Should the data be rescaled,truncated,...
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A MANAGER’S GUIDE TO THE DESIGN AND CONDUCT OF CLINICAL TRIALS - PART 10 potx
... 73Bailar, J. C., 219 , 228, 234Baker, A. , 11 9Baltch, A. L., 11 5, 12 0Barbui, C., 57Barkhof, F., 74Barnard, G. A. , 2 31, 234Baron, J., 12 0Barr, R. G., 11 8, 12 0 A Manager’s Guide to the Design and ... 239Hardware, 27, 229, 16 2Hardware checklist, 16 2HCOL Clinical Study, 239Health fairs, 11 4Hierarchical databases, 14 5, 15 3Histogram, 18 1Historical databases, 71, 10 7HTML format, 99 10 2ICH ... (DBMS), 15 0Database manager, 30, 15 6Databaseaccess, 14 8, 15 5backup, 15 8combining, 15 1protection, 15 7regulatory agency accesstypes, 14 3 14 8client-server, 15 0testing, 15 8Data Desk/ActivStats/DataDesk...
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