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 Revised Chapters, upon release.

  • Data Management Plan, revised edition December 2019
  • CRF Completion Guidelines, revised edition December 2019
  • Vendor Selection and Management, revised edition January 2020

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.

The GCDMP© Revision authors will host a public webinar on Monday, March 2 to present the updates you’ll find in the new, revised edition of Electronic Data Capture – Implementation and Study Start-up.

 

Download the chapter below and join us for the online session!

CALL FOR PUBLIC REVIEWS

Electronic Data Capture – Selecting an EDC System

Public Comment Period Closes March 30

Electronic Data Capture – Implementation and Study Start-up

Public Comment Period Closes March 30

Submit Your Feedback

SCDM invites you to share your feedback on the GCDMP© revisions prior to publications. Submit your comments and help us build the most advanced CDM Reference Publication in the world!

How to submit your feedback:
• Download a comment sheet.
• As you read the draft chapter, record your comments in the columns provided.
• Email your completed comment sheet to [email protected].
Every comment will be read and resolved by the authors, so this is your opportunity to contribute your expertise to the revision project.

 

GCDMP© REVISIONS PROJECT CALENDAR:

Electronic Data Capture Chapter 3 – Study Conduct, Maintenance and Close-Out
(Draft Chapter will be released for public comment February 2020)

Electronic Data Capture Authors present online session describing the revisions: March 2020
Edit Check Design Principles
(Draft Chapter will release for public comment April 2020)

The first of the new writing chapter groups that will launch in 2020 are:

  • Design of Human-completed Forms
  • Lab Data Handling
  • Assuring Data Quality
  • Database Lock

First of NEW writing groups launch – March 2020
Measuring Data Quality, Integration of External Data, & Safety Data Management
(first draft projected summer 2020)

Administrative updates and translation work ongoing through 2020

It’s not to late to join us for the kick-off! Contact Sara Wilkinson at [email protected] 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.

Get your free Chinese Copy

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

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)