Practical Guide to Clinical Data Management / Edition 5

Hardcover (Print)
Used and New from Other Sellers
Used and New from Other Sellers
from $3.11
Usually ships in 1-2 business days
(Save 98%)
Other sellers (Hardcover)
  • All (7) from $3.11   
  • Used (7) from $3.11   
Close
Sort by
Page 1 of 1
Showing All
Note: Marketplace items are not eligible for any BN.com coupons and promotions
$3.11
Seller since 2006

Feedback rating:

(60266)

Condition:

New — never opened or used in original packaging.

Like New — packaging may have been opened. A "Like New" item is suitable to give as a gift.

Very Good — may have minor signs of wear on packaging but item works perfectly and has no damage.

Good — item is in good condition but packaging may have signs of shelf wear/aging or torn packaging. All specific defects should be noted in the Comments section associated with each item.

Acceptable — item is in working order but may show signs of wear such as scratches or torn packaging. All specific defects should be noted in the Comments section associated with each item.

Used — An item that has been opened and may show signs of wear. All specific defects should be noted in the Comments section associated with each item.

Refurbished — A used item that has been renewed or updated and verified to be in proper working condition. Not necessarily completed by the original manufacturer.

Good
Shows some signs of wear, and may have some markings on the inside. 100% Money Back Guarantee. Shipped to over one million happy customers. Your purchase benefits world literacy!

Ships from: Mishawaka, IN

Usually ships in 1-2 business days

  • Canadian
  • International
  • Standard, 48 States
  • Standard (AK, HI)
  • Express, 48 States
  • Express (AK, HI)
$18.99
Seller since 2014

Feedback rating:

(51)

Condition: Good
Buy with Confidence. Excellent Customer Support. We ship from multiple US locations. No CD, DVD or Access Code Included.

Ships from: Fort Mill, SC

Usually ships in 1-2 business days

  • Standard, 48 States
$21.05
Seller since 2014

Feedback rating:

(61)

Condition: Good
Good Hardcover edition, no dust jacket. Book is like new, appears unread. Ships same/next day with tracking/delivery confirmation.

Ships from: Austin, TX

Usually ships in 1-2 business days

  • Canadian
  • International
  • Standard, 48 States
  • Standard (AK, HI)
  • Express, 48 States
  • Express (AK, HI)
$33.16
Seller since 2014

Feedback rating:

(290)

Condition: Good
Possible retired library copy, some have markings or writing. May or may not include accessories such as CD or access codes.

Ships from: Chatham, NJ

Usually ships in 1-2 business days

  • Canadian
  • International
  • Standard, 48 States
  • Standard (AK, HI)
  • Express, 48 States
  • Express (AK, HI)
$103.00
Seller since 2014

Feedback rating:

(2)

Condition: Like New
1/31/1999 Hardcover 1 Fine Media-Hardcover-Condition-Like new Pub_year-1999. Please provide street address as we ship using DHL/Fedex Express.

Ships from: North Vancouver, Canada

Usually ships in 1-2 business days

  • Canadian
  • International
  • Standard, 48 States
  • Standard (AK, HI)
  • Express, 48 States
  • Express (AK, HI)
$115.25
Seller since 2014

Feedback rating:

(290)

Condition: Like New
As new.

Ships from: Chatham, NJ

Usually ships in 1-2 business days

  • Canadian
  • International
  • Standard, 48 States
  • Standard (AK, HI)
  • Express, 48 States
  • Express (AK, HI)
$192.91
Seller since 2008

Feedback rating:

(16059)

Condition: Like New
Like New condition.

Ships from: Frederick, MD

Usually ships in 1-2 business days

  • Canadian
  • International
  • Standard, 48 States
  • Standard (AK, HI)
  • Express, 48 States
  • Express (AK, HI)
Page 1 of 1
Showing All
Close
Sort by

Overview

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 conducttheir work with efficiency and quality.
Read More Show Less

Product Details

  • ISBN-13: 9781574910438
  • Publisher: CRC Press
  • Publication date: 1/31/1999
  • Edition description: Older Edition
  • Edition number: 5
  • Pages: 296
  • Product dimensions: 6.14 (w) x 9.40 (h) x 0.89 (d)

Table of Contents

include:
ELEMENTS OF THE PROCESS Data Management Plan Study Setup Tracking CRF Data Entering Data Managing Lab Data Identifying and Managing Discrepancies Collecting Adverse Event Data Coding Reported Terms Creating Reports and Transferring Data Closing Studies Identifying & Managing Discrepancies

CDM SYSTEMS Where Systems Come From Choosing Vendor Products Implementing New Systems Systems Validation Test Plans Migrating Legacy Data Change Control

SPECIAL TOPICS Creating Data Standards SOPs and Guidelines Working With CROs CRF Design Considerations Remote Data Entry Autocoder Algorithms

APPENDICES Appendix A: Data Management Plan Outline Appendix B: Database Design Document Outline Appendix C: Validation Plan Outline Appendix D: Test Plan Outline

GLOSSARY SELECTED READING INDEX

Read More Show Less

Customer Reviews

Be the first to write a review
( 0 )
Rating Distribution

5 Star

(0)

4 Star

(0)

3 Star

(0)

2 Star

(0)

1 Star

(0)

Your Rating:

Your Name: Create a Pen Name or

Barnes & Noble.com Review Rules

Our reader reviews allow you to share your comments on titles you liked, or didn't, with others. By submitting an online review, you are representing to Barnes & Noble.com that all information contained in your review is original and accurate in all respects, and that the submission of such content by you and the posting of such content by Barnes & Noble.com does not and will not violate the rights of any third party. Please follow the rules below to help ensure that your review can be posted.

Reviews by Our Customers Under the Age of 13

We highly value and respect everyone's opinion concerning the titles we offer. However, we cannot allow persons under the age of 13 to have accounts at BN.com or to post customer reviews. Please see our Terms of Use for more details.

What to exclude from your review:

Please do not write about reviews, commentary, or information posted on the product page. If you see any errors in the information on the product page, please send us an email.

Reviews should not contain any of the following:

  • - HTML tags, profanity, obscenities, vulgarities, or comments that defame anyone
  • - Time-sensitive information such as tour dates, signings, lectures, etc.
  • - Single-word reviews. Other people will read your review to discover why you liked or didn't like the title. Be descriptive.
  • - Comments focusing on the author or that may ruin the ending for others
  • - Phone numbers, addresses, URLs
  • - Pricing and availability information or alternative ordering information
  • - Advertisements or commercial solicitation

Reminder:

  • - By submitting a review, you grant to Barnes & Noble.com and its sublicensees the royalty-free, perpetual, irrevocable right and license to use the review in accordance with the Barnes & Noble.com Terms of Use.
  • - Barnes & Noble.com reserves the right not to post any review -- particularly those that do not follow the terms and conditions of these Rules. Barnes & Noble.com also reserves the right to remove any review at any time without notice.
  • - See Terms of Use for other conditions and disclaimers.
Search for Products You'd Like to Recommend

Recommend other products that relate to your review. Just search for them below and share!

Create a Pen Name

Your Pen Name is your unique identity on BN.com. It will appear on the reviews you write and other website activities. Your Pen Name cannot be edited, changed or deleted once submitted.

 
Your Pen Name can be any combination of alphanumeric characters (plus - and _), and must be at least two characters long.

Continue Anonymously

    If you find inappropriate content, please report it to Barnes & Noble
    Why is this product inappropriate?
    Comments (optional)