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 2 Transferring Data 15 4 Quality Assurance and Security 15 5 Maintaining Patient Confidentiality 15 5 Access to Files 15 5 Maintaining an Audit Trail 15 7 Security ... 18 4 Extending the Trials 18 6 Budgets and Expenditures 18 6 For Further Information 18 7 15 Data Analysis 18 9 Report Coverage 18 9 Understanding Data...
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 p...
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 19 91 and 19 94, CANDAs in the United States were approved ... the 5- to 10 -page protocols common in the academic area, and industry collection forms can range from 50 to 200 pages per patient, in contrast to the...
Ngày tải lên: 14/08/2014, 07:20
A MANAGER’S GUIDE TO THE DESIGN AND CONDUCT OF CLINICAL TRIALS - PART 6 pdf
... to you 2. Transfer of data from data entry to data storage and from data storage to your report generating and statistical analysis software 3. Maintaining the security and integrity of your data OPTIONS Flat ... quickly? Hierarchical Databases The traditional answer to some of these issues was the hierarchical database model. A hierarchical database is a series...
Ngày tải lên: 14/08/2014, 07:20
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 data manager. Cross-functional review and approval by biostatistics, CRMs, and medical affairs. Instruction manuals Design team,...
Ngày tải lên: 14/08/2014, 07:20
A MANAGER’S GUIDE TO THE DESIGN AND CONDUCT OF CLINICAL TRIALS - PART 8 pot
... 2 8 019 217 911 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 48 20 0 13 1 13 21 0 13 1 13 will have no reason to believe the two treatments have ... of the eligibility criteria, the proportion of males and females, average age of the par- ticipants and so forth. For categorical va...
Ngày tải lên: 14/08/2014, 07:20
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 trea...
Ngày tải lên: 14/08/2014, 07:20
A MANAGER’S GUIDE TO THE DESIGN AND CONDUCT OF CLINICAL TRIALS - PART 10 potx
... 73 Bailar, J. C., 219 , 228, 234 Baker, A. , 11 9 Baltch, A. L., 11 5, 12 0 Barbui, C., 57 Barkhof, F., 74 Barnard, G. A. , 2 31, 234 Baron, J., 12 0 Barr, R. G., 11 8, 12 0 A Manager’s Guide to the Design and ... 239 Hardware, 27, 229, 16 2 Hardware checklist, 16 2 HCOL Clinical Study, 239 Health fairs, 11 4 Hierarchical databases, 14 5, 15 3 Histogram, 18 1 Hi...
Ngày tải lên: 14/08/2014, 07:20
- verilog hdl a guide to digital design and synthesis 2nd ed
- verilog a guide to digital design and synthesis pdf
- verilog hdl a guide to digital design and synthesis 2nd pdf
- verilog hdl a guide to digital design and synthesis download
- verilog hdl a guide to digital design and synthesis
- verilog hdl a guide to digital design and synthesis pdf
- verilog hdl a guide to digital design and synthesis solution