[PDF] Practical Guide to Clinical Data Management 4th Edition, Kindle Edition Android

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2
Description
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.FeaturesProvi
des 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.
3
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Description
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.FeaturesProvi
des 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.
6
PDF Practical Guide to Clinical Data Management
4th Edition, Kindle Edition Android