PROGRAMA
XIII Curso/Taller de Buenas Prácticas en la Investigación Clínica
19, 20 y 21 de abril 2007
Sede: Hotel Guatemala City Marriot
Salones Piedras Negras y Xelaju
Jueves 19 de Abril
Horario Conferencia
19:30-19:45 Inauguración
19:45-20:30 Investigación Clínica
Historia y Evolución de Regulación y Principio de Ética
20:30-21:00 Normativas y Leyes de Investigación en Guatemala
21:00-22:00 Cóctel
Viernes 20 de Abril
Horario Conferencia
08:00-08:30 Fases de Investigación Clínica
08:30-09:15 Análisis Critico del Protocolo I
09:15-09:30 Preguntas
09:30-10:00 Análisis Critico del Protocolo II
10:00-10:30 Consentimiento Informado: Requerimientos
Generales, Elementos Obligatorios, Opcionales
Y Excepcionales
10:30-10:45 Receso - Café
10:45-12:30 Manejo de Problemas- Trabajo por grupos
12:30-13:00 Comités Institucionales/Científicos: Generalidades,
Organización de los mismos, Funciones y Obligaciones.
13:00-14:00 Almuerzo
14:00-15:00 Eventos Adversos y Reportes
15:00-15:30 Captura y Manejo de Datos
Formas y Reporte de Caso (Papel, electrónico)
Manejo de Discrepancias
15:30-16:30 Manejo de Problemas. Trabajo por Grupos
16:30-16:45 Receso - Café
16:45-18:15 Manejo de Problemas. Trabajo por Grupos.
Sabado 21 de Abril
Horario Conferencia
08:00-08:30 Medicamentos de Investigación:
Comparativos, Placebo, Acuse de Recibo,
Contabilidad, Vencimiento y Destrucción.
08:30-09:00 Documento Fuente:
Papeletas o Fichas Clínica, Reportes de
Laboratorio, Rayos X, Templates, Etc.
09:00-09:30 Responsabilidades del Investigador, de la
Institución y del Patrocinador.
09:30-10:30 Auditorias y Fraude
10:30-11:45 Receso - Café
11:45-12:00 Manejo de Problemas-Trabajo en Grupos
12:00-13:00 Evaluación.
Costo
Medico Socio $.250.00
Medico Residente $.150.00
Estudiante y Enfermero $.100.00
Medico No socio $.450.00
Profesionales en General $.450.00
Mayor información:
En la Sede de AMIG
12 Calle 2-04 Zona 9 Oficina 319 Nivel 3
Tel: 23605285/95
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