The Good Clinical Data Management Practice (GCDMP©)
is an indispensable reference and
benchmark for data managers worldwide.
GCDMP©
Explore best practices in
Clinical Data Management
The GCDMP© provides comprehensive best practices covering essential data management domains, recent chapters including:
- NEW: Risk-Based Clinical Data Management
- Design and Development of Data Collection Instruments
- Guidance for eCOA Development in Clinical Trials
- Software Development Life Cycle
- CRF Completion Guidelines
- Data Management Plan
- Vendor Selection & Management
- Electronic Data Capture-Selecting an EDC System
- Electronic Data Capture-Stuy Conduct, Maintenance and Closeout
- Electronic Data Capture-Study Implementation and Start-up
NEW CHAPTER
Risk-Based Clinical Data Management (RB-CDM)
The GCDMP has expanded with a new chapter on Risk-Based Clinical Data Management (RB-CDM), providing practical guidance for applying Quality by Design (QbD), Risk-Based Quality Management (RBQM), and fit-for-purpose principles throughout the clinical study lifecycle.
Grounded in evolving regulatory expectations and industry best practices, this chapter reflects an important milestone for both the GCDMP and the profession. It highlights how clinical data professionals can focus effort where it matters most: participant protection, study quality, and reliable results.
"From my early days as a data manager, the GCDMP© was my go-to guide, shaping my understanding of data management and providing invaluable insights. Throughout my career, I've relied on its guidance for tackling regulatory challenges and ensuring adherence to best practices. With the new user-friendly format and ongoing updates, GCDMP© remains my trusted resource. Join me in exploring its latest enhancements and leveraging it as your definitive data management guideline!"
Magda Jaskowska, SCDM Board Trustee & GCDMP Working Group Lead
Global Director/Leader of TA for Oncology in Data Strategy and Management, GSK
UPCOMING: GCDMP© PUBLIC REVIEW
Contribute with your comments to future chapters entering public review:
- Edit Check Design
- Data Quality
The GCDMP© guidelines ensure that data is collected, handled, and reported accurately and consistently, which is crucial for the integrity of clinical trials.
To uphold the quality of these practices, having experts review the GCDMP© chapters is vital for several reasons:
- Accuracy and Quality
- Diverse Perspectives
- Relevance and Usability
- Continuous Improvement
Interested in contributing? Keep an eye on this space when one of the upcoming chapters enter into public review.
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