Practical Guide to Clinical Data ManagementCRC Press, 26/10/2011 - 296 من الصفحات The management of clinical data, from its collection during a trial to its extraction for analysis, has become a critical element in the steps to prepare a regulatory submission and to obtain approval to market a treatment. Groundbreaking on its initial publication nearly fourteen years ago, and evolving with the field in each iteration since then, |
المحتوى
The Data Management Plan | 3 |
CRF Design Considerations | 9 |
Database Design Considerations | 23 |
Edit Checks | 37 |
Preparing to Receive Data | 43 |
Receiving Data on Paper | 55 |
Overseeing Data Collection | 65 |
Cleaning Data | 73 |
Clinical Data Management Systems | 171 |
EDC Systems | 175 |
Choosing Vendor Products | 183 |
Implementing New Systems | 191 |
System Validation | 199 |
Test Procedures | 207 |
Change Control | 213 |
Coding Dictionaries and Systems | 219 |
Managing Lab Data | 87 |
NonCRF Data | 97 |
Collecting Adverse Event Data | 103 |
Creating Reports and Transferring Data | 113 |
Study Database Lock | 123 |
After Database Lock | 133 |
Standard Operating Procedures SOPs | 139 |
Training | 149 |
Controlling Access and Security | 155 |
Working with CROs | 161 |
Migrating and Archiving Data | 229 |
Data Management Plan Outline | 235 |
Clinical Data Management SOPs | 239 |
CROSponsor Responsibility Matrix | 243 |
Implementation Plan Outline | 247 |
Validation Plan Outline | 249 |
CDISC and HIPAA | 251 |
Bibliography | 253 |
Back Cover | 255 |
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عبارات ومصطلحات مألوفة
actual addition adverse event allow analysis appear application appropriate approval associated audit changes Chapter cleaning clinical clinical data coding collected companies complete conduct consider correct create data entry data management data management groups database defined discrepancies discussion document eCRF EDC systems edit checks electronic entered errors example expected fields FIGURE final given guidelines identify important kind lock manual missing monitor normal noted particular performed possible practice problems procedures programs protocol query questions range received records require response sample signs SOPs specific sponsor staff standard step stored tasks term tracking transfer trial typically units updates usually validation values vendor