Foreword |
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ix | |
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1 An Introduction to Clinical Research Concepts |
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1 | (24) |
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1 | (1) |
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1.2 The level of evidence hierarchy |
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1 | (4) |
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1.3 A bird's-eye view of statistics in clinical research |
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5 | (6) |
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1.4 Clinical studies of investigational therapies |
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11 | (5) |
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1.5 Clinical studies of established therapies |
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16 | (1) |
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1.6 Experimental design of comparative-effectiveness studies |
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17 | (4) |
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1.7 Evaluation of medical software |
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21 | (2) |
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23 | (2) |
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24 | (1) |
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2 Supporting Clinical Research Computing: Technological and Nontechnological Considerations |
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25 | (24) |
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2.1 Technological aspects: software development |
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25 | (4) |
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2.2 Nontechnical factors: overview |
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29 | (1) |
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2.3 Attitude: service versus research |
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29 | (2) |
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31 | (2) |
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2.5 General skills and breadth of knowledge |
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33 | (1) |
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34 | (1) |
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2.7 Managing people and projects |
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35 | (4) |
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39 | (1) |
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40 | (1) |
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2.10 Choosing your collaborators |
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41 | (3) |
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2.11 Topics in clinical research support |
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44 | (5) |
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46 | (3) |
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3 Core Informatics Technologies: Data Storage |
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49 | (36) |
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3.1 Types of data elements: databases 101 |
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49 | (7) |
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3.2 Transactional databases versus analytical databases |
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56 | (7) |
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63 | (12) |
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3.4 Managing integrated (structured + unstructured) data |
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75 | (2) |
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3.5 Nonrelational approaches to data management: "NoSQL" systems |
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77 | (6) |
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83 | (2) |
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83 | (2) |
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4 Core Technologies: Machine Learning and Natural Language Processing |
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85 | (30) |
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4.1 Introduction to machine learning |
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85 | (1) |
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4.2 The bridge between traditional statistics and machine learning |
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85 | (4) |
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4.3 A basic glossary of machine learning |
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89 | (4) |
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4.4 Regression-based methods |
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93 | (1) |
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4.5 Regression-type methods for categorical outcome variables |
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94 | (4) |
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4.6 Artificial neural networks |
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98 | (1) |
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4.7 Bayes' theorem and Naive Bayes methods |
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99 | (2) |
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4.8 Methods for sequential data |
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101 | (7) |
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4.9 Introduction to natural language processing |
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108 | (5) |
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113 | (2) |
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113 | (2) |
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5 Software for Patient Care Versus Software for Clinical Research Support: Similarities and Differences |
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115 | (14) |
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115 | (1) |
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5.2 Similarities between EHRs and CSDMSs |
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116 | (1) |
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5.3 EHRs are specialized for clinical care and workup |
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117 | (1) |
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5.4 CSDMSs: study participants (subjects) are not necessarily patients |
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117 | (1) |
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5.5 Study protocol: overview |
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118 | (1) |
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5.6 Configuration information |
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119 | (1) |
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5.7 Recruitment and eligibility |
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120 | (1) |
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121 | (5) |
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5.9 Multiinstitutional or multinational research scenarios |
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126 | (3) |
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128 | (1) |
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6 Clinical Research Information Systems: Using Electronic Health Records for Research |
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129 | (14) |
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6.1 Biospecimen management systems |
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130 | (1) |
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6.2 Grants management systems |
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131 | (1) |
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6.3 Clinical research workflow support systems |
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132 | (2) |
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6.4 Clinical study data management systems |
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134 | (2) |
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6.5 Using EHRs for research |
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136 | (4) |
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6.6 Effective interoperation between a CSDMS and EHR-related software |
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140 | (3) |
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142 | (1) |
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7 Computer Security, Data Protection, and Privacy Issues |
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143 | (16) |
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143 | (3) |
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7.2 Special concerns related to personal data |
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146 | (1) |
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146 | (2) |
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7.4 Institutional preparedness |
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148 | (1) |
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7.5 HIPAA matters: calibrating the level of privacy to the level of acceptable risk |
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149 | (3) |
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7.6 A primer on electronic intrusion |
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152 | (2) |
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7.7 State of healthcare systems with respect to intrusion resistance |
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154 | (1) |
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7.8 Role of the US Government |
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155 | (4) |
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157 | (2) |
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8 Mobile Technologies and Clinical Computing |
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159 | (14) |
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159 | (1) |
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8.2 Uses of mobile devices: historical and recent |
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160 | (3) |
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8.3 Applications in biomedical research |
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163 | (2) |
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8.4 Limitations of mobile devices |
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165 | (8) |
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170 | (3) |
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9 Clinical Data Repositories: Warehouses, Registries, and the Use of Standards |
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173 | (14) |
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173 | (1) |
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9.2 Operational data store |
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173 | (1) |
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9.3 Data warehouses and data marts |
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174 | (6) |
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180 | (2) |
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9.5 Encoding data prior to warehousing: standardization challenges |
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182 | (2) |
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9.6 Relationships between healthcare IT and health informatics groups |
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184 | (3) |
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185 | (2) |
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10 Core Technologies: Data Mining and "Big Data" |
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187 | (18) |
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187 | (3) |
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10.2 An overview of data-mining methodology |
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190 | (5) |
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10.3 Limitations and caveats |
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195 | (4) |
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199 | (1) |
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200 | (1) |
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10.6 Additional resources for learning |
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201 | (4) |
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203 | (2) |
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11 Conclusions: The Learning Health System of the Future |
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205 | (12) |
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205 | (1) |
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11.2 Origin and inspiration for the LHS proposal |
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206 | (3) |
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11.3 Challenges of KM/BPR for US healthcare |
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209 | (8) |
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215 | (2) |
Subject Index |
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217 | |