Clinical Data Management
Richard K. Rondel, Sheila A. Varley, Colin F. Webb
John Wiley & Sons, Feb 3, 2000 - Medical - 354 pages
Extensively revised and updated, with the addition of new chapters and authors, this long-awaited second edition covers all aspects of clinical data management. Giving details of the efficient clinical data management procedures required to satisfy both corporate objectives and quality audits by regulatory authorities, this text is timely and an important contribution to the literature.
* is written by well-known and experienced authors in this area
* provides new approaches to major topics in clinical data management
* contains new chapters on systems software validation, database design and performance measures.
It will be invaluable to anyone in the field within the pharmaceutical industry, and to all biomedical professionals working in clinical research.
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The International Conference on Harmonisation and its Impact
Case Report Form Design
Planning and Implementation
Quality Assurance and Clinical Data Management
Database Design Issues for Central Laboratories
Systems Software Validation IssuesClinical Trials Database
Reengineering the Clinical Data Management Process
Working with Contract Research Organizations
Data Management in Epidemiology and Pharmacoeconomics
Coding of DataMedLRA and other Medical Terminologies
Other editions - View all
activities adverse events analysis audit trail autoencoder changes clinical data management clinical database clinical development clinical research Clintrial coding computer systems Contract Research Organisations correct cost COSTART CRF design cycle data capture data entry data management process data presentation data validation defined disorders documents drug effective electronic data capture ensure evaluation example Form Filler format guidelines harmonisation High Level Term identify implementation in-house integrity internal investigator Lowest Level Terms MedDRA medical terminology medicinal product ment monitoring operators Oracle Clinical organisation patient number performance pharmaceutical companies pharmacoeconomic pharmacovigilance phase Preferred Terms procedures process flow programs project team protocol Pulmonary oedema queries re-engineering records regulatory authorities requirements resource response retrieval S.A. Varley safety solutions specific sponsor staff standard statistical System Organ Class Table tasks testing timelines tion workflow