Practical Guide to Clinical Data Management (2nd Edition, 2011)

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: _7 R  L4 z% t/ o3 z- z7 ~Title: Practical Guide to Clinical Data Management
9 Q4 B2 R8 z/ W1 _' XAuthor(s): Susanne Prokscha
Publisher: CRC Press
Year: 2006       
Edition: 2nd
' @8 ^0 ]8 K$ T; E- R) cLanguage: English       
, J- m7 g/ i9 w- {Pages: 254
ISBN: 0849376157, 9780849376153, 9781420007886
Size: 6 MB (6803559 bytes)       
+ H! {, [7 R3 x! n7 \+ YExtension: pdf


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 to the highly computerized specialty it is today.Practical Guide to Clinical Data Management, Second Edition provides a solid introduction to the key process elements of clinical data management. Offering specific references to regulations and other FDA documents, it gives guidance on what is required in data handling. Updates to the Second Edition include -A summary of the modifications that data management groups have made under 21 CFR 11, the regulation for electronic records and signaturesPractices for both electronic data capture (EDC)-based and paper-based studiesA new chapter on Necessary Infrastructure, which addresses the expectations of the FDA and auditors for how data management groups carry out their work in compliance with regulationsThe edition has been reorganized, covering the basic data management tasks that all data managers must understand. It also focuses on the computer systems, including EDC, that data management groups use and the special procedures that must be in place to support those systems. Every chapter presents a range of successful and, above all, practical options for each element of the process or task.Focusing on responsibilities that data managers have today, this edition provides practitioners with an approach that will help them conduct their work with efficiency and quality.
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2 t) O+ p7 \" K" C( n& }- O" fTable of contents :
Front cover......Page 1
5 \4 f( W' r( s( C& ]+ K3 @Preface......Page 6
The Author......Page 8
. l( Z& l# k7 {5 h9 YContents......Page 10
part one. Elements of the process......Page 16
chapter one. The data management plan......Page 18
chapter two. CRF design considerations......Page 24
  ~; [  Z' I/ M- |  ?( D% ?chapter three. Database design considerations......Page 34
* Z1 |5 c7 b- r- q( ?) Fchapter four. Study setup......Page 50
chapter five. Entering data......Page 58
chapter six. Tracking CRF pages and corrections......Page 68
* V+ J2 i' o. Z+ N% kchapter seven. Cleaning data......Page 76
( P" X$ Y  j1 G: Pchapter eight. Managing laboratory data......Page 90
4 {# D' |, E- \( L. ?9 jchapter nine. Collecting adverse event data......Page 104
8 F! }4 ^0 ?" U) w% bchapter ten. Creating reports and transferring data......Page 114
chapter eleven. Locking studies......Page 122
% K& k! W. i* {% R) `# vpart two. Necessary infrastructure......Page 130
chapter twelve. Standard operating procedures and guidelines......Page 132
chapter thirteen. Training......Page 142
: H3 ?' S% s3 `) o$ tchapter fourteen. Controlling access and security......Page 148
8 Y  m7 y2 M1 cchapter fifteen. Working with CROs......Page 154
part three. CDM systems......Page 162
; a% R' D7 J" u4 b% Rchapter sixteen. Clinical data management systems......Page 164
/ `5 t5 n4 E2 ^: N3 W+ cchapter seventeen. Electronic data capture systems......Page 168
9 @! X) ]. _) `3 Zchapter eighteen. Choosing vendor products......Page 178
chapter nineteen. Implementing new systems......Page 186
chapter twenty. System validation......Page 194
chapter twenty one. Test procedures......Page 202
chapter twenty two. Change control......Page 208
chapter twenty three. Coding dictionaries......Page 214
* F( f4 f' f( H; ], k+ f6 ychapter twenty four. Migrating and archiving data......Page 224
appendix A: Data management plan outline......Page 230
appendix B: Typical data management standard operating procedures......Page 234
appendix C: CRO-sponsor responsibility matrix......Page 236
appendix D. Implementation plan outline......Page 238
appendix E: Validation plan outline......Page 240
appendix F: CDISC and HIPAA......Page 242
Index......Page 244
5 Z8 [$ a3 B* e$ _: r/ ABack cover......Page 254


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非常感谢！

好书好书 学习

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