Clinical Data Management eBook

Clinical Data Management eBook

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Clinical Data Management - A Beginner’s Guide

Overview

Clinical Data Management (CDM) involves the process of collecting, storing, managing, analyzing, reporting, submitting and archiving clinical data generated from clinical trials which are conducted as a part of the drug development process, to ensure good quality, clean data that is fit for submission to the regulatory authorities.

About the Book

Clinical Data Management, A Beginner’s Guide is intended for students and enthusiasts willing to make a career in clinical data management.

The book first describes the processes involved in developing a new drug (drug discovery, pre-clinical development and clinical development) and then explains each of these processes in detail with special emphasis on computer systems and methods that are used for the same in the industry today.

The book is a resource on the following topics:

- Overview of R&D in the Pharmaceutical Industry
- Drug discovery process
- Phases of Drug development
- Overview of Clinical Data Management
- Methods of Clinical Data Collection and Management
- Clinical Data Management System (CDMS)
- Oracle Clinical – A Case Study
- 21 CFR Part 11 regulations
- Form and System Design
- Selecting, validating, installing and configuring a CDMS
- Patient Management
- Quality Assurance
- Handling AE’s and SAE’s
- Database Lock and Freeze
- Retention and Archival of Clinical Data
- Electronic Data Capture (EDC)
- Clinical Data Interchange Standards Consortium (CDISC)

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Recently changed in this version

Minor bugfix in version 1.1


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Comments and ratings for Clinical Data Management eBook
  • (69 stars)

    by Abhijeet Safai on 01/02/2014

    I found it nice. Great to have this book in your mobile. Was helpful when had nothing to do

  • (69 stars)

    by vinay tiwari on 25/10/2013

    More good books required.

  • (69 stars)

    by Jai Raj Kashyap on 23/09/2013

    AWESOME!!

  • (69 stars)

    by kavi k.b.v.s on 10/06/2013

    It's like a handbook of CDMS Good read,,,,,

  • (69 stars)

    by farnaz fathima on 03/06/2013

    Basically easy to understand book. Great.

  • (69 stars)

    by A Google User on 06/10/2012

    Detailed eBook on Clinical Data Management. Recommended for all clinical data management professionals

  • (69 stars)

    by Roopika on 07/10/2011

    Really nice...
    Detailed eBook on Clinical Data Management. Recommended for all clinical data management professionals