CLINICAL COMPETENCE;
CLINICAL PROTOCOL;
CLINICAL TRIAL (TOPIC);
FINANCIAL MANAGEMENT;
FOOD AND DRUG ADMINISTRATION;
HUMAN;
NATIONAL HEALTH ORGANIZATION;
ORGANIZATION AND MANAGEMENT;
PROGRAM DEVELOPMENT;
QUALITY CONTROL;
STANDARDS;
TOTAL QUALITY MANAGEMENT;
TRUST;
UNITED STATES;
CLINICAL COMPETENCE;
CLINICAL PROTOCOLS;
CLINICAL TRIALS AS TOPIC;
DRUGS, INVESTIGATIONAL;
HUMANS;
NATIONAL INSTITUTES OF HEALTH (U.S.);
PROGRAM DEVELOPMENT;
QUALITY CONTROL;
RESEARCH SUPPORT AS TOPIC;
TOTAL QUALITY MANAGEMENT;
TRUST;
UNITED STATES;
UNITED STATES FOOD AND DRUG ADMINISTRATION;
Transforming Clinical Research in the United States: Challenges and Opportunities:Workshop Summary.Washington DC: National Academies Press
Institute of Medicine Forum on Drug Discovery, Development, and Translation. Transforming Clinical Research in the United States: Challenges and Opportunities:Workshop Summary.Washington, DC: National Academies Press; 2010.
Publication and reporting of clinical trial results: Cross sectional analysis across academic medical centers
Chen R, Desai NR, Ross JS, et al. Publication and reporting of clinical trial results: cross sectional analysis across academic medical centers. BMJ. 2016;352:i637.
National Institutes of Health. NIH and FDA Request for Public Comment on Draft Clinical Trial Protocol Template for Phase 2 and 3 IND/IDE Studies. Accessed September 7
National Institutes of Health. NIH and FDA Request for Public Comment on Draft Clinical Trial Protocol Template for Phase 2 and 3 IND/IDE Studies. http://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-043.html. Accessed September 7, 2016.
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Costs and benefits of the national cancer institute central institutional review board
Wagner TH, Murray C, Goldberg J, Adler JM, Abrams J. Costs and benefits of the national cancer institute central institutional review board. J Clin Oncol. 2010;28(4):662-666.
National Institutes of Health. Final NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research. Accessed September 7
National Institutes of Health. Final NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research. https://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-094.html. Accessed September 7, 2016.
(2016)
8
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National Center for Advancing Translational Sciences, National Institutes of Health. NCATS SMART IRB Reliance Authorization Agreement. Accessed September 7
National Center for Advancing Translational Sciences, National Institutes of Health. NCATS SMART IRB Reliance Authorization Agreement. https://ncats.nih.gov/files/smart-authorization-agreement-6-2016.pdf. Accessed September 7, 2016.
(2016)
9
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NIH Policy on dissemination of NIH-funded clinical trial information
National Institutes of Health
National Institutes of Health. NIH Policy on dissemination of NIH-funded clinical trial information. Fed Regist. 2016;81(183). https://www.federalregister.gov/.
Department of Health and Human Services, Washington DC. Fed Regist
Department of Health and Human Services. Final Rule-Clinical Trials Registration and Results Information Submission.Washington, DC. Fed Regist. 2016;81(183). https://s3.amazonaws.com/public-inspection.federalregister.gov/2016-22129.pdf.