GCDMP©

Explore best practices in
Clinical Data Management

The Good Clinical Data Management Practice (GCDMP©)
is an indispensable reference and
benchmark for data managers worldwide.

GCDMP© LEGACY CHAPTERS

The CDM profession fundamentals

The GCDMP© legacy chapters outline key principles in data management that provide a foundation for current practices and offer insight into the historic evolution of the CDM profession.

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Good Clinical Data Management Practices

Good Clinical Data Management Practices. Journal of the Society for Clinical Data Management. 2023; 1(1): 21, pp. 1–4. DOI: https://doi.org/10.47912/jscdm.344

Keywords: Clinical Data Management; Research Data Management; Data Curation

“The need for Good Clinical Data Management Practices is not new. In the early 1970s, the Public Health Service recognized this need through a contract to a major research university for training of research data managers. However, the need continues, the need changes over time, and the need for good clinical data management practices has become even more important as biopharmaceutical and medical device industry and regulatory bodies rely more and more heavily on the evaluation of electronically transmitted clinical trials data for critical data-based decision making.”

Thus, the Society for Clinical Data Management provides the Good Clinical Data Management Practices to the SCDM membership.

This document constitutes neither consensus nor endorsement by regulatory agencies, pharmaceutical or biotech companies, contract research organizations or the academic community, but rather reflects the current views of SCDM membership. Additionally, none of the recommendations contained herein supersede regulations or regulatory guidelines, which should always be consulted prospectively to assure compliance. The document should not be considered an exhaustive list of topics.

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Data Privacy

Data Privacy. Journal of the Society for Clinical Data Management. 2023; 1(1): 20, pp. 1–5. DOI: https://doi.org/10.47912/jscdm.341

Keywords: Clinical Data Management; Data Privacy; Good Clinical Practice

The privacy of any subject who participates in a clinical study must be protected for ethical and legal reasons. Clinical data management professionals must be familiar with privacy laws that exist for the regions in which clinical studies are occurring and ensure all reasonable and appropriate precautions are taken. This chapter discusses strategies and considerations that data managers must understand and follow, including the varying types of personal data in clinical studies, best practices for securing and protecting data (both paper and electronic), methods of data collection, and strategies for ensuring that personnel, both internal and external (e.g., vendors), follow applicable data privacy standards.

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Project Management for the Clinical Data Manager

Project Management for the Clinical Data Manager. Journal of the Society for Clinical Data Management. 2023; 1(1): 19, pp. 1–7. DOI: https://doi.org/10.47912/jscdm.340 

Keywords: Clinical Data Management; Project Management

Clinical data managers often assume some degree of project management responsibilities. This chapter discusses the discipline of project management and how to effectively apply project management principles to clinical data management. The chapter describes specific project management activities within a clinical data management department, and discusses the desired competencies of a data manager assuming project management responsibilities.

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Design and Development of Data Collection Instruments

Design and Development of Data Collection Instruments. Journal of the Society for Clinical Data Management. 2023; 1(1): 22, pp. 1–7. DOI: https://doi.org/10.47912/jscdm.339

Keywords: Clinical Data Management; Case Report Form; Good Clinical Practice

Clinical data can be collected with a variety of tools, but case report forms are the most frequently used data collection tool. Case report forms may be paper based or electronic and include data entry forms used by patients as well as health care providers. This chapter provides guidelines for the design of case report forms, emphasizing accurate, consistent and logical data collection in accordance with a study’s protocol. The design and development processes discussed highlight the importance of a case report form’s clarity and ease of use. The chapter also discusses referential questions, redundancies, edit checks, standards, case report form completion guidelines, and distinctions for studies using paper CRFs, electronic data capture and/or patient-reported outcomes.

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Edit Check Design Principles

Edit Check Design Principles. Journal of the Society for Clinical Data Management. 2023; 1(1): 18, pp. 1–8. DOI: https://doi.org/10.47912/jscdm.338

Keywords: Clinical Data Management; Global Library; Edit Checks

Edit checks are invaluable tools for increasing data quality and providing greater efficiency during data review and cleaning activities. This chapter discusses the process of edit check creation, including balance and efficiency considerations. The chapter also describes different types of edit checks, edit check validation, strategies for edit check specification creation, training related to edit checks, and considerations for using edit checks in studies that are paper based or use electronic data capture.

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