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

We first started out as ?The Paperback Exchange,? a chain of physical bookstores where we would part exchange your beloved books for new stories to transport you to faraway places. However, as shopping started to evolve to online shops and marketplaces, we bid our stores goodbye to become ?PBShop.? This transition has only allowed us to blossom as we now ship thousands of titles to book lovers across the globe. We pride ourselves in being a community of local book lovers which allows our passion and devotion to shine in everything we do. In 2020 we not only celebrated our 20th birthday but our 1st birthday as being completely employee owned after becoming an E.O.T in September 2019. We are proud to be different and embrace standing apart on a book mountain by working from a virtual inventory which allows us to provide thousands of books that may be difficult to get for your bookshelf or your studies. Working with a number of different suppliers allows us to explore other avenues such as puzzles, sheet music and even stationery so we really do have something for everyone. Life is about being versatile in all realms of existence. If this is your first visit or you are a returning customer, we would like to welcome you to the PBShop family, for there is no friend as loyal as a book. We are a company who put our customers at the centre of everything we do as we understand the importance of reading because once you learn to read, you will forever be free. There are a whole lot of things in this world of ours that we are yet to explore, which is why we will forever inspire curious minds.

Visit Seller's Storefront

Seller's business information

Pbshop.co.uk Ltd
Unit 22 Horcott Industrial Estate, Horcott Road, Fairford, GL7 4BX, United Kingdom

Sale & Shipping Terms

Terms of Sale

Returns Policy
We ask all customers to contact us for authorisation should they wish to return their order. Orders returned without authorisation may not be credited.
If you wish to return, please contact us within 14 days of receiving your order to obtain authorisation.

Returns requested beyond this time will not be authorised.

Our team will provide full instructions on how to return your order and once received our returns department will process your refund.
Please note the cost to return any...

More Information

Shipping Terms

Books are shipped from UK warehouse. Delivery thereafter is between 4 and 14 business days dependant upon your location - please do contact us with any queries you may have.

Shipping rates within U.S.A.

Shipping rates within U.S.A.
Order quantity	7 to 14 business days	7 to 14 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.