The management of clinical data, from its collection during a trial to its extraction for analysis, has become critical in preparing a regulatory submission and obtaining approval to market a treatment. Groundbreaking on its initial publication nearly 14 years ago, and evolving with the field in each iteration since then, this latest volume includes revisions to all chapters to reflect the recent updates to ICH E6, good clinical practices, electronic data capture, and interactive response technologies. Keeping the coverage practical, the author focuses on the most critical information that impacts clinical trial conduct, providing a full end-to-end overview for clinical data managers.

Features:

Provides an introduction and background information for the spectrum of clinical data management tasks.
Outstanding text in the industry and has been used by the Society for Clinical Data Management in creating its certification exam.
Explains the high-level flow of a clinical trial from creation of the protocol through study lock.
Reflects electronic data capture and interactive response technologies.
Discusses using the concept of three phases in the clinical data management of a study: study startup, study conduct, and study closeout, to write procedures and train staff.

About the Author

Susanne Prokscha has been involved in clinical data management (CDM) processes and technologies since the mid-1980's. She has worked both as a consultant and directly for companies large and small, gaining experience with a wide range of studies and a variety of CDM systems. Since 2007, Susanne has been focusing on standard operating procedure (SOP) development, document management, and training plans for CDM and for other functions in clinical research and development.

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

Store Description

Professional Book Seller offering fast shipping and hassle-free returns for every order. Our 100% satisfaction policy guarantees that you get the best product and the best service at the best price!

Visit Seller's Storefront

Seller's business information

Basi6 International LLC
1018 Camino Lago, Irving, TX, 75039, U.S.A.

Sale & Shipping Terms

Terms of Sale

Professional Book Seller shipping from Multiple Locations Worldwide for fastest delivery possible!

If you are a consumer you can cancel the contract in accordance with the following. Consumer means any natural person who is acting for purposes which are outside his trade, business, craft or profession.

INFORMATION REGARDING THE RIGHT OF CANCELLATION

Statutory Right to cancel

You have the right to cancel this contract within 14 days without giving any reason.

The cancellation period will expire af...

More Information

Shipping Terms

All orders shipped via FedEx or DHL and delivered to your doorstep within 3-5 days. We do not ship to P.O.Boxes and a proper street address must be provided to avoid any delays.

Shipping rates within U.S.A.

Shipping rates within U.S.A.
Order quantity	5 to 14 business days	3 to 6 business days
First item	US$ 0.00	US$ 0.00

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.