Clinical Research Data Management: Experience of the N. N. Burdenko NMRC of Neurosurgery

2020 ◽  
pp. 6-14
Author(s):  
G.V. Danilov ◽  
◽  
M. A. Shifrin ◽  
T. E. Pronkina ◽  
J. V. Strunina ◽  
...  
Keyword(s):  
Clinical Research ◽  
Data Management ◽  
Research Data ◽  
Research Data Management ◽  
Management Experience ◽  
Clinical Research Data

scholarly journals VARIABILITY IN CLINICAL RESEARCH DATA MANAGEMENT PRACTICES: LESSONS FROM THE MALARIA COMMUNITY

2017 ◽  
Vol 2 (Suppl 2) ◽  
pp. A19.1-A19
Author(s):  
Amélie Julé ◽  
Hazel Ashurst ◽  
Laura Merson ◽  
Piero Olliaro ◽  
Vicki Marsh ◽  
...  
Keyword(s):  
Clinical Research ◽  
Data Management ◽  
Management Practices ◽  
Research Data ◽  
Research Data Management ◽  
Clinical Research Data

scholarly journals Clinical research data management in the United States: Where we've been and where we're going

2021 ◽  
Author(s):  
Mary Banach ◽  
Kaye H Fendt ◽  
Johann Proeve ◽  
Dale Plummer ◽  
Samina Qureshi ◽  
...  
Keyword(s):  
Clinical Research ◽  
Data Management ◽  
Clinical Data ◽  
Management Practices ◽  
The United States ◽  
Research Data ◽  
Fda Guidance ◽  
Research Data Management ◽  
Challenges And Opportunities ◽  
Clinical Research Data

With the focus of the COVID-19 pandemic, we wanted to reach all stakeholders representing communities concerned with good clinical data management practices. We wanted to represent not only data managers but bio-statisticians, clinical monitors, data scientists, informaticians, and all those who collect, organize, analyze, and report on clinical research data. In our paper we will discuss the history of clinical data management in the US and its evolution from the early days of FDA guidance. We will explore the role of biomedical research focusing on the similarities and differences in industry and academia clinical research data management and what we can learn from each other. We will talk about our goals for recruitment and training for the CDM community and what we propose for increasing the knowledge and understanding of good clinical data practice to all – particularly our front-line data collectors i.e., nurses, medical assistants, patients, other data collectors. Finally, we will explore the challenges and opportunities to see CDM as the hub for good clinical data research practices in all of our communities.We will also discuss our survey on how the COVID-19 pandemic has affected the work of CDM in clinical research.

Biomedical and Clinical Research Data Management

2021 ◽  
pp. 532-543
Author(s):  
Matthias Ganzinger ◽  
Enrico Glaab ◽  
Jules Kerssemakers ◽  
Sven Nahnsen ◽  
Ulrich Sax ◽  
...  
Keyword(s):  
Clinical Research ◽  
Data Management ◽  
Research Data ◽  
Research Data Management ◽  
Clinical Research Data

scholarly journals Health Sciences Libraries Advancing Collaborative Clinical Research Data Management in Universities

2018 ◽  
Vol 7 (2) ◽  
pp. e1130
Author(s):  
Tania Bardyn ◽  
◽  
Emily Patridge ◽  
Michael Moore ◽  
Jane Koh ◽  
...  
Keyword(s):  
Clinical Research ◽  
Data Management ◽  
Health Sciences ◽  
Research Data ◽  
Research Data Management ◽  
Clinical Research Data

scholarly journals Analysis of professional competencies for the clinical research data management profession: implications for training and professional certification

2017 ◽  
Vol 24 (4) ◽  
pp. 737-745 ◽  
Author(s):  
Meredith N Zozus ◽  
Angel Lazarov ◽  
Leigh R Smith ◽  
Tim E Breen ◽  
Susan L Krikorian ◽  
...  
Keyword(s):  
Clinical Research ◽  
Data Management ◽  
Scientific Discipline ◽  
Research Data ◽  
Professional Competencies ◽  
Degree Programs ◽  
Professional Certification ◽  
Research Data Management ◽  
Clinical Research Informatics ◽  
Clinical Research Data

Abstract Objective: To assess and refine competencies for the clinical research data management profession. Materials and Methods: Based on prior work developing and maintaining a practice standard and professional certification exam, a survey was administered to a captive group of clinical research data managers to assess professional competencies, types of data managed, types of studies supported, and necessary foundational knowledge. Results: Respondents confirmed a set of 91 professional competencies. As expected, differences were seen in job tasks between early- to mid-career and mid- to late-career practitioners. Respondents indicated growing variability in types of studies for which they managed data and types of data managed. Discussion: Respondents adapted favorably to the separate articulation of professional competencies vs foundational knowledge. The increases in the types of data managed and variety of research settings in which data are managed indicate a need for formal education in principles and methods that can be applied to different research contexts (ie, formal degree programs supporting the profession), and stronger links with the informatics scientific discipline, clinical research informatics in particular. Conclusion: The results document the scope of the profession and will serve as a foundation for the next revision of the Certified Clinical Data ManagerTM exam. A clear articulation of professional competencies and necessary foundational knowledge could inform the content of graduate degree programs or tracks in areas such as clinical research informatics that will develop the current and future clinical research data management workforce.

scholarly journals Curadoria de dados de pesquisa em repositórios de ensaios clínicos: uma revisão de escopo | Curating research data in clinical trial repositories: a scoping review

2019 ◽  
Vol 15 (2) ◽  
Author(s):  
Fabiana De Melo Amaral Gonçalves Pinto ◽  
Janaynne Carvalho Do Amaral ◽  
Melina De Brito Dos Santos
Keyword(s):  
Clinical Trial ◽  
Data Management ◽  
Open Science ◽  
Research Data ◽  
Science Data ◽  
Data Description ◽  
Research Data Management ◽  
Management Policies ◽  
Science Movement ◽  
Clinical Research Data

RESUMO O artigo investiga a prática da curadoria de dados de pesquisa em repositórios de ensaios clínicos. Propõe reflexões sobre a informação e seus múltiplos formatos no domínio da saúde e sugere uma definição para dados de pesquisa clínicos. Apresenta o conceito de curadoria de dados de pesquisa e fomenta novos estudos que priorizam a discussão sobre a gestão de dados de pesquisa e o movimento da Ciência Aberta no domínio da saúde. Aponta para a necessidade de implantação de políticas de gestão de dados de pesquisa que assegurem critérios de descrição, sistematização, compartilhamento, recuperação, interoperabilidade, preservação e reuso de dados. Como reflexão final, ressalta o desafio de discutir e implementar a prática de curadoria de dados de pesquisa produzidos por ensaios clínicos e evidencia o vasto e oportuno campo a ser explorado, tanto para pesquisadores quanto para profissionais da informação.Palavras-chave: Curadoria de Dados; Dados de Pesquisa; Ensaio Clínico; Ciência Aberta; Reuso de Dados.ABSTRACT The article investigates the practice of curating research data in clinical trial repositories. That proposes reflections on health information and its multiple formats and suggests the definition for clinical research data. It introduces the concept of research data curation and promotes new studies, which prioritize the discussion about research data management and the Open Science movement in the health domain. The article brings points to the need to implement research data management policies that ensure criteria for data description, systematization, sharing, retrieval, interoperability, preservation and reuse. As a final reflection, it highlights the challenge of discussing and implementing the practice of curating research data produced by clinical trials and highlights the vast and timely field to be explored for both researchers and information professionals.Keywords: Data Curator; Research data; Clinical Trial; Open Science; Data Reuse.Lista 

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