Template protocol for clinical trials investigating vaccines—Focus on safety elements

Autor:	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, 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, Kalifa, Bojang
Rok vydání:	2013
Předmět:	medicine.medical_specialty Biomedical Research 030231 tropical medicine Standard operation procedure Article 03 medical and health sciences 0302 clinical medicine Informed consent medicine Humans Medical physics 030212 general & internal medicine Case report form Protocol (science) Clinical Trials as Topic Vaccines General Veterinary General Immunology and Microbiology business.industry Public Health Environmental and Occupational Health Institutional review board 3. Good health Clinical trial Infectious Diseases Good clinical practice Molecular Medicine business Relevant information
Zdroj:	Vaccine; Vol 31
ISSN:	0264-410X
DOI:	10.1016/j.vaccine.2013.02.041
Popis:	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.
Databáze:	OpenAIRE
Externí odkaz:	https://explore.openaire.eu/search/publication?articleId=doi_dedup___::5a3c58ee9e04895119917f249c7c740e https://doi.org/10.1016/j.vaccine.2013.02.041 Zobrazit plný text záznamu Full Text from ScienceDirect