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 signatures

Practices for both electronic data capture (EDC)-based and paper-based studies

A 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 regulations

The 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.

"About this title" may belong to another edition of this title.

Store Description

Visit Seller's Storefront

Seller's business information

SHIMEDIA
NY, U.S.A.

Sale & Shipping Terms

Terms of Sale

Shipping Terms

Shipping rates within U.S.A.

Shipping rates within U.S.A.
Order quantity	5 to 14 business days	5 to 14 business days
First item	US$ 0.00	US$ 14.00

Delivery times are set by sellers and vary by carrier and location. Orders passing through Customs may face delays and buyers are responsible for any associated duties or fees. Sellers may contact you regarding additional charges to cover any increased costs to ship your items.