Ética de la investigación en salud

12/12/2022

A Review of the Availability of Information on Ethics Committee Requierements for Clinical Trials en the EU (2011)

Filed under: Guías — Tania Izquierdo Pamias @ 9:06 pm

A Review of the Availability of Information on Ethics Committee Requierements for Clinical Trials en the EU (2011)

Detailed guidance on the application format and documentation to be submitted to a Ethics Committee for medicinal products for clinical Trials. EC

Filed under: Guías — Tania Izquierdo Pamias @ 9:00 pm

Detailed guidance on the application format and documentation to be submitted to a Ethics Committee for medicinal products for clinical Trials. EC

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

Filed under: Guías — Tania Izquierdo Pamias @ 8:57 pm

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

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

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

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

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Autor: Tania Izquierdo Pamias | Contáctenos
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