Template protocol for clinical trials investigating vaccines--focus on safety elements.
Vaccine
; 31(47): 5602-20, 2013 Nov 12.
Article
em En
| MEDLINE
| ID: mdl-23499603
Palavras-chave
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
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Vacinas
/
Ensaios Clínicos como Assunto
/
Pesquisa Biomédica
Tipo de estudo:
Guideline
Limite:
Humans
Idioma:
En
Revista:
Vaccine
Ano de publicação:
2013
Tipo de documento:
Article