| Article ID | Journal | Published Year | Pages | File Type |
|---|---|---|---|---|
| 10966075 | Vaccine | 2013 | 19 Pages |
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.
Keywords
CRFLMICICFGCPNIHIRBAEFIFDACouncil for International Organizations of Medical SciencesDSMBSOPSAEIDMCCSPCIOMSUnited States Food and Drug AdministrationImmunizationSafetystandard operation procedureAdverse event following immunizationWorld Health OrganizationLSMgood clinical practiceSerious adverse eventcase report formICHinstitutional review boardData and Safety Monitoring BoardVaccineProtocolClinical trialLow and middle income countryindependent ethics committeeIECInternational Conference on HarmonizationWHO
Related Topics
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Immunology
Authors
Jan Bonhoeffer, 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,