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. 2019 Jul 19:15:100423.
doi: 10.1016/j.conctc.2019.100423. eCollection 2019 Sep.

Resources to assist in the transition to a single IRB model for multisite clinical trials

Cynthia Hahn  1 , Petra Kaufmann  2 , Soo Bang  3 , Sara Calvert  4
Affiliations

Resources to assist in the transition to a single IRB model for multisite clinical trials

Cynthia Hahn et al. Contemp Clin Trials Commun. .
No abstract available

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Figures

Fig. 1
Fig. 1
Timeline of single IRB requirements and release of implementation Resources Abbreviations: ANPRM = Advance notice of proposed rulemaking; CTTI=Clinical trials transformation initiative; FDA=Food and drug administration; IAA=IRB Authorization agreement; IRB=Instituional review board; NCATS=National center for advancing Translational sciences; NEJM=New england journal of medicine; NIH=National institutes of health; NPRM=Notice of proposed rulemaking; SMART=Streamlined, Multisite, Accelerated resources for trials.
See this image and copyright information in PMC

References

    1. 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
    1. Department of Homeland Security Federal policy for the protection of human subjects. Fed. Regist. 2017;82(12):7149–7274. https://www.federalregister.gov/documents/2017/01/19/2017-01058/federal-... Available at. - PubMed
    1. Abbott D., Califf R., Morrison B.W., Pierre C., Bolte J., Chakraborty S. Cycle time metrics for multisite clinical trials in the United States. Ther Innov Regul Sci. 2013;47:152–160. - PubMed
    1. Ravina B., Deuel L., Siderowf A., Dorsey E.R. Local institutional review board (IRB) review of a multicenter trial: local costs without local context. Ann. Neurol. 2010;67:258–260. - PMC - PubMed
    1. Wagner T.H., Murray C., Goldberg J., Adler J.M., Abrams J. Costs and benefits of the National Cancer Institute central institutional review board. J. Clin. Oncol. 2010;28:662–666. - PMC - PubMed

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