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A call to incorporate systems theory and human factors into the existing investigation of harm in clinical research involving healthcare products.
Edwards BD, Bégaud B, Daemen E, Dokas I, Fishbein JM, Greenberg HE, Hochberg A, Le Louet H, Lyngvig J, Mogles N, Owen K, Prendergast C, Rejzek M, Trantza S, Webb DJ, Whalen M, Whiteley S. Edwards BD, et al. Br J Clin Pharmacol. 2017 Nov;83(11):2339-2342. doi: 10.1111/bcp.13353. Epub 2017 Jul 19. Br J Clin Pharmacol. 2017. PMID: 28681444 Free PMC article.
Accreditation of Clinical Research Sites - Moving Forward.
Koski G, Kennedy L, Tobin MF, Whalen M. Koski G, et al. N Engl J Med. 2018 Aug 2;379(5):405-407. doi: 10.1056/NEJMp1806934. Epub 2018 Jun 27. N Engl J Med. 2018. PMID: 29949451 No abstract available.