Ética de la investigación en salud

12/12/2022

Ethical considerations for clinical trials on medicinal products conducted with the pediatric population

Filed under: Guías — Tania Izquierdo Pamias @ 8:54 pm

Ethical considerations for clinical trials on medicinal products conducted with the pediatric population. EC

Bioresearch Monitoring Program (BIMO) – Institutional Review Board. FDA

Filed under: Guías — Tania Izquierdo Pamias @ 8:44 pm

Bioresearch Monitoring Program (BIMO) – Institutional Review Board. FDA

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

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