The Good Clinical Data Management Practices (GCDMP©) standard provides a reference to clinical data managers in their implementation of high quality Clinical Data Management processes and is used as a guidance tool for clinical data managers when preparing for CDM training and education.

We are currently revising the chapters of the GCDMP.  Take a look at our progress in publishing the most advanced Clinical Data Management reference book worldwide!

COMPLETED CHAPTERS

Download your New Edition Chapters, upon release.

  • Data Management Plan, Evidence Based Chapter
  • CRF Completion Guidelines, Evidence Based Chapter
  • Vendor Selection and Management

Note: The GCDMP© is a copyright protected document and may not be copied, published or distributed by any means without permission from SCDM. It is solely available to individuals who purchase it for private use and is not transferrable to any other entities.

UPCOMING CHAPTERS:

  • Electronic Data Capture Chapter 2 – EDC Implementation and Study Start-Up (Draft Chapter will be released for public comments in January, 2020)
  • Electronic Data Capture Chapter 3Study Conduct, Maintenance and Close-Out (Draft Chapter will be released for public comments in Q1, 2020)
  • Edit Check Design Principles (Draft Chapter will be released for public comments in Q1, 2020)
  • Measuring Data Quality  (Draft Chapter will be released for public comments in Q1, 2020)
  • Integration of External Data  (Draft Chapter will be released for public comments in Q1/Q2, 2020)
  • Safety Data Management (Draft Chapter will be released for public comments in Q1/Q2, 2020)

CALL TO ACTION

VOLUNTEERS NEEDED!

CALL FOR PUBLIC REVIEWS

Electronic Data Capture – Selecting an EDC System

Now available for public reviews!

SCDM invites you to share your feedback on the draft before February 10, 2020. Submit your comments and help us build the most advanced CDM Reference Publication in the world!

How to submit your feedback:

  • Download the draft chapter and comment sheet below
  • As you read, record your feedback for the authors using the comment sheet, and then
  • Upload your completed comments sheet using the form below.

 

GCDMP CHAPTERS PUBLIC REVIEW FORM

Please upload your review file *
Only TXT files are accepted

Ten new chapter revision working groups will launch in q1 2020:

  • Design of Human-completed Forms
  • Lab Data Handling
  • Assuring Data Quality
  • Medical Coding
  • Database Lock
  • Data Archival
  • Pro —> eCOA
  • Data Privacy
  • Database Validation
  • eSource (NEW chapter)
If you are interested in contributing to the authorship of any of these chapter revisions/original text, please contact Sara Wilkinson at swilkinson@scdm.org to receive information about what kind of necessary skills and time-commitment the project entails and to register  your interest in a particular chapter group.

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Translation sponsored by Jiaxing Tai Mei Medical Technology Co., Ltd.