Ética de la investigación en salud

12/12/2022

CPGM for Institutional Review Boards. FDA

Filed under: Guías — Tania Izquierdo Pamias @ 8:40 pm

CPGM for Institutional Review Boards. FDA

Frequently Asked Questions – IRB Registration. FDA

Filed under: Guías — Tania Izquierdo Pamias @ 8:37 pm

Frequently Asked Questions – IRB Registration. FDA

Informed Consent Elements Final Rule (Federal Register). FDA (pdf)

Filed under: Regulaciones internacionales — Tania Izquierdo Pamias @ 8:36 pm

Informed Consent Elements Final Rule (Federal Register). FDA (pdf)

IRB Continuing Review After Clinical Investigation Approval 2012 FDA

Filed under: Guías — Tania Izquierdo Pamias @ 8:29 pm

IRB Continuing Review After Clinical Investigation Approval 2012 FDA

Proposed Collection; Comment Request; NIH NCI Central Institutional Review Board (CIRB) Iniciative

Filed under: En las entradas — Tania Izquierdo Pamias @ 8:18 pm

Proposed Collection; Comment Request; NIH NCI Central Institutional Review Board (CIRB) Iniciative

FDA-2008-Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs. Frecuently asked questions-statement of investigator (Form FDA 1572)

Filed under: Guías — Tania Izquierdo Pamias @ 7:29 pm

FDA-2008-Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs. Frecuently asked questions-statement of investigator (Form FDA 1572)

FDA. Guidance for Clinical Investigators, Sponsors, and IRBs – Adverse Event Reporting to IRBs ­ Improving Human Subject Protection 2009

Filed under: Guías — Tania Izquierdo Pamias @ 7:19 pm

Guidance for Clinical Investigators, Sponsors, and IRBs – Adverse Event Reporting to IRBs ­ Improving Human Subject Protection 2009

International ethical guidelines for health-related research involving humans 2016

Filed under: Guías — Tania Izquierdo Pamias @ 7:17 pm

International ethical guidelines for health-related research involving humans 2016

EMEA. Reflection paper on the need for active control in therapeutic areas where use of placebo is deemed ethical and one or more established medicines

Filed under: Guías — Tania Izquierdo Pamias @ 7:13 pm

EMEA. Reflection paper on the need for active control in therapeutic areas where use of placebo is deemed ethical and one or more established medicines

Anexo 06 de la Regulación 21-00 Requerimientos para la solicitud de modificaciones a ensayos clínicos autorizados

Filed under: Regulaciones nacionales — Tania Izquierdo Pamias @ 7:00 pm

Anexo 06 de la Regulación 21-00 Requerimientos para la solicitud de modificaciones a ensayos clínicos autorizados

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