| Literature DB >> 23499603 |
Jan Bonhoeffer1, Egeruan B Imoukhuede, Grace Aldrovandi, Novilia S Bachtiar, Eng-Soon Chan, Soju Chang, Robert T Chen, Rohini Fernandopulle, Karen L Goldenthal, James D Heffelfinger, Shah Hossain, Indira Jevaji, Ali Khamesipour, Sonali Kochhar, Mamodikoe Makhene, Elissa Malkin, David Nalin, Rebecca Prevots, Ranjan Ramasamy, Sarah Sellers, Johan Vekemans, Kenneth B Walker, Pam Wilson, Virginia Wong, Khalequz Zaman, Ulrich Heininger.
Abstract
This document is intended as a guide to the protocol development for trials of prophylactic vaccines. The template may serve phases I-IV clinical trials protocol development to include safety relevant information as required by the regulatory authorities and as deemed useful by the investigators. This document may also be helpful for future site strengthening efforts.Entities:
Keywords: AEFI; Adverse Event Following Immunization; CIOMS; CRF; CSP; Case Report Form; Central Safety Physician; Clinical trial; Council for International Organizations of Medical Sciences; DSMB; Data and Safety Monitoring Board; FDA; GCP; Good Clinical Practice; ICF; ICH; IDMC; IEC; IRB; Immunization; Independent Ethics Committee; Informed Consent Form; Institutional Review Board; International Conference on Harmonization; LMIC; LSM; Local Safety Monitor; Low and Middle Income Country; NIH; Protocol; SAE; SOP; Safety; Serious Adverse Event; Standard Operation Procedure; The Independent Data Monitoring Committee; United States Food and Drug Administration; United States National Institutes of Health; Vaccine; WHO; World Health Organization
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Year: 2013 PMID： 23499603 PMCID： PMC4586124 DOI： 10.1016/j.vaccine.2013.02.041
Source DB: PubMed Journal: Vaccine ISSN： 0264-410X Impact factor: 3.641