GCDMP©

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!

Electronic Data Capture –
Study Conduct, Maintenance and Close-out.

Draft chapter open to public comment

The revised edition of this chapter of the GCDMP covers:

  • the regulatory basis for practices in EDC study conduct, maintenance, and close-out
  • special considerations for ongoing data surveillance and use when using web-based EDC
  • common processes used in study conduct of EDC-based studies
  • methods for managing system access and privileges
  • common practices for EDC system maintenance and change control during studies
  • special considerations for close-out of EDC-based studies

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.

 

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.

GCDMP© REVISIONS PROJECT CALENDAR:

Electronic Data Capture Chapter 3 – Study Conduct, Maintenance and Close-Out:
Draft text opens to public comment Summer 2020

Electronic Data Capture Chapter 1 and 2
Final draft with incorporated comments will publish Fall 2020

Edit Check Design Principles
Draft Chapter will release for public comment Fall 2020

Measuring Data Quality
Draft Chapter will release for public comment late Fall 2020

Administrative updates and translation work ongoing through 2020

First of NEW writing groups launch – Summer 2020
The first of the new writing chapter groups that will launch in 2020 are:

  • Medical Coding
  • Assuring Data Quality
  • Database Lock
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.

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Translation sponsored by Jiaxing Tai Mei Medical Technology Co., Ltd.
Edition 2013
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