Practical Guide to Clinical Data ManagementCRC Press, 01/08/2006 - 256 من الصفحات The management of clinical data, from its collection 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. As its importance has grown, clinical data management (CDM) has changed from an essentially clerical task in the late 1970s and early 1980s t |
المحتوى
part one Elements of the process | 1 |
chapter one The data management plan | 3 |
chapter two CRF design considerations | 9 |
chapter three Database design considerations | 19 |
chapter four Study setup | 35 |
chapter five Entering data | 43 |
chapter six Tracking CRF pages and corrections | 53 |
chapter seven Cleaning data | 61 |
chapter sixteen Clinical data management systems | 149 |
chapter seventeen Electronic data capture systems | 153 |
chapter eighteen Choosing vendor products | 163 |
chapter nineteen Implementing new systems | 171 |
chapter twenty System validation | 179 |
chapter twenty one Test procedures | 187 |
chapter twenty two Change control | 193 |
chapter twenty three Coding dictionaries | 199 |
chapter eight Managing laboratory data | 75 |
chapter nine Collecting adverse event data | 89 |
chapter ten Creating reports and transferring data | 99 |
chapter eleven Locking studies | 107 |
part two Necessary infrastructure | 115 |
chapter twelve Standard operating procedures and guidelines | 117 |
chapter thirteen Training | 127 |
chapter fourteen Controlling access and security | 133 |
chapter fifteen Working with CROs | 139 |
part three CDM systems | 147 |
chapter twenty four Migrating and archiving data | 209 |
Data management plan outline | 215 |
Typical data management standard operating procedures | 219 |
CROsponsor responsibility matrix | 221 |
appendix D Implementation plan outline | 223 |
Validation plan outline | 225 |
CDISC and HIPAA | 227 |
| 229 | |
Back cover | 239 |
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عبارات ومصطلحات مألوفة
actual additional analysis application approach appropriate associated assurance audit autocoder Chapter checks clinical data coding collected common companies complete consider correct create data entry data management groups database database design defined detail dictionary discrepancy discussion document edit effort electronic entered event example expected fields final followed format frequently guidelines identify impact implementation important involved kind lock look management system manual migration missing normal noted operating particular patient performed pilot possible practices problems procedures production programs query question range record reports require responsible separate SOPs specific sponsor staff standard steps stored structures tasks testing tracking transfer trials typically usually validation values vendor