Practical Guide to Clinical Data Management

الغلاف الأمامي
CRC 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
حقوق النشر

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عبارات ومصطلحات مألوفة

نبذة عن المؤلف (2011)

Susanne Prokscha is an Independent Consultant working with Genentech in South San Francisco, California.

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