[PDF] Responsibilities of Data Monitoring Committees | Semantic Scholar Skip to search formSkip to main content> Semantic Scholar's Logo Search Sign InCreate Free Account You are currently offline. Some features of the site may not work correctly. DOI:10.1177/2168479016646812 Corpus ID: 52303889Responsibilities of Data Monitoring Committees @article{Bierer2016ResponsibilitiesOD, title={Responsibilities of Data Monitoring Committees}, author={B. Bierer and R. Li and J. Seltzer and L. Sleeper and Elizabeth Frank and C. Knirsch and Carmen E. Aldinger and R. Levine and Joe M Massaro and A. Shah and M. Barnes and S. Snapinn and J. Wittes}, journal={Therapeutic Innovation & Regulatory Science}, year={2016}, volume={50}, pages={648 - 659} } B. Bierer, R. Li, +10 authors J. Wittes Published 2016 Medicine Therapeutic Innovation & Regulatory Science Background: A data monitoring committee (DMC) has special responsibilities for protecting the safety of clinical trial participants. [...] Key Method All members of the group have formed, served on, advised, or worked with DMCs. Results: The group outlined the objectives and mechanics of running a DMC, including operational and practical considerations, membership characteristics, roles, members’ liability, and indemnification. Further, it delineated the roles and responsibilities of each DMC member…Expand View on SAGE mrctcenter.org Save to Library Create Alert Cite Launch Research Feed Share This Paper 4 Citations View All Tables and Topics from this paper table 1 table 2 table 3 table 4 table 4 table 5 table 5 View All 7 Figures & Tables Clinical Trial Independent Data Monitoring Committee Charter responsibility Academia (organization) Mechanics Advocate (person) 4 Citations Citation Type Citation Type All Types Cites Results Cites Methods Cites Background Has PDF Publication Type Author More Filters More Filters Filters Sort by Relevance Sort by Most Influenced Papers Sort by Citation Count Sort by Recency Data monitoring committees: Promoting best practices to address emerging challenges T. Fleming, D. Demets, +15 authors S. Ellenberg Business, Medicine Clinical trials 2017 22 PDF Save Alert Research Feed Reports to Independent Data Monitoring Committees K. Buhr, Matthew T. Downs, Janelle Rhorer, Robin Bechhofer, J. Wittes Computer Science, Medicine Therapeutic innovation & regulatory science 2018 5 Save Alert Research Feed How to construct an optimal interim report: What the data monitoring committee does and doesn’t need to know J. Neaton, B. Grund, D. Wentworth Psychology, Medicine Clinical trials 2018 9 Save Alert Research Feed Issues for Masked Data Monitoring O. D. Williams, K. Epnere Business 2019 Save Alert Research Feed References SHOWING 1-8 OF 8 REFERENCES Liability issues for data monitoring committee members D. Demets, T. Fleming, +7 authors R. Califf Business, Medicine Clinical trials 2004 24 PDF View 8 excerpts, references background and methods Save Alert Research Feed On independent data monitoring committees in oncology clinical trials. J. Wittes, Mark Schactman Medicine Chinese clinical oncology 2014 5 View 2 excerpts, references methods Save Alert Research Feed Behind closed doors: the data monitoring board in randomized clinical trials. J. Wittes Medicine Statistics in medicine 1993 45 View 2 excerpts, references methods Save Alert Research Feed Data monitoring in clinical trials D. Demets, C. Furberg, L. Friedman Medicine 2006 13 View 3 excerpts, references methods and background Save Alert Research Feed Data Monitoring Committees in Clinical Trials S. Ellenberg, T. Fleming, D. Demets Medicine 2002 164 Save Alert Research Feed Ethical and scientific implications of the globalization of clinical research. Charla A Andrews Medicine The New England journal of medicine 2009 207 Save Alert Research Feed and Drug Administration Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees. Silver Spring, MD: US FDA; 2006 Data Monitoring Committees in Clinical Trials: A Practical Perspective. Patricia M. Grambsch Medicine 2003 84 View 3 excerpts, references methods and background Save Alert Research Feed Related Papers Abstract Tables and Topics 4 Citations 8 References Related Papers Stay Connected With Semantic Scholar Sign Up About Semantic Scholar Semantic Scholar is a free, AI-powered research tool for scientific literature, based at the Allen Institute for AI. Learn More → Resources DatasetsSupp.aiAPIOpen Corpus Organization About UsResearchPublishing PartnersData Partners   FAQContact Proudly built by AI2 with the help of our Collaborators Terms of Service•Privacy Policy The Allen Institute for AI By clicking accept or continuing to use the site, you agree to the terms outlined in our Privacy Policy, Terms of Service, and Dataset License ACCEPT & CONTINUE