Ética de la investigación en salud » Guías https://files.sld.cu/eticaeninvestigacion Repositorio de documentos del sitio Fri, 31 Mar 2023 18:43:02 +0000 es-ES hourly 1 http://wordpress.org/?v=4.1 A Review of the Availability of Information on Ethics Committee Requierements for Clinical Trials en the EU (2011) https://files.sld.cu/eticaeninvestigacion/2022/12/12/a-review-of-the-availability-of-information-on-ethics-committee-requierements-for-clinical-trials-en-the-eu-2011/ https://files.sld.cu/eticaeninvestigacion/2022/12/12/a-review-of-the-availability-of-information-on-ethics-committee-requierements-for-clinical-trials-en-the-eu-2011/#comments Mon, 12 Dec 2022 21:06:01 +0000 http://files.sld.cu/eticaeninvestigacion/?p=109 A Review of the Availability of Information on Ethics Committee Requierements for Clinical Trials en the EU (2011)

]]> https://files.sld.cu/eticaeninvestigacion/2022/12/12/a-review-of-the-availability-of-information-on-ethics-committee-requierements-for-clinical-trials-en-the-eu-2011/feed/ 0 Detailed guidance on the application format and documentation to be submitted to a Ethics Committee for medicinal products for clinical Trials. EC https://files.sld.cu/eticaeninvestigacion/2022/12/12/detailed-guidance-on-the-application-format-and-documentation-to-be-submitted-to-a-ethics-committee-for-medicinal-products-for-clinical-trials-ec/ https://files.sld.cu/eticaeninvestigacion/2022/12/12/detailed-guidance-on-the-application-format-and-documentation-to-be-submitted-to-a-ethics-committee-for-medicinal-products-for-clinical-trials-ec/#comments Mon, 12 Dec 2022 21:00:05 +0000 http://files.sld.cu/eticaeninvestigacion/?p=106 Detailed guidance on the application format and documentation to be submitted to a Ethics Committee for medicinal products for clinical Trials. EC

]]> https://files.sld.cu/eticaeninvestigacion/2022/12/12/detailed-guidance-on-the-application-format-and-documentation-to-be-submitted-to-a-ethics-committee-for-medicinal-products-for-clinical-trials-ec/feed/ 0 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 https://files.sld.cu/eticaeninvestigacion/2022/12/12/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/ https://files.sld.cu/eticaeninvestigacion/2022/12/12/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/#comments Mon, 12 Dec 2022 20:57:56 +0000 http://files.sld.cu/eticaeninvestigacion/?p=103 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

]]> https://files.sld.cu/eticaeninvestigacion/2022/12/12/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/feed/ 0 Ethical considerations for clinical trials on medicinal products conducted with the pediatric population https://files.sld.cu/eticaeninvestigacion/2022/12/12/ethical-considerations-for-clinical-trials-on-medicinal-products-conducted-with-the-pediatric-population/ https://files.sld.cu/eticaeninvestigacion/2022/12/12/ethical-considerations-for-clinical-trials-on-medicinal-products-conducted-with-the-pediatric-population/#comments Mon, 12 Dec 2022 20:54:41 +0000 http://files.sld.cu/eticaeninvestigacion/?p=100 Ethical considerations for clinical trials on medicinal products conducted with the pediatric population. EC

]]> https://files.sld.cu/eticaeninvestigacion/2022/12/12/ethical-considerations-for-clinical-trials-on-medicinal-products-conducted-with-the-pediatric-population/feed/ 0 Bioresearch Monitoring Program (BIMO) – Institutional Review Board. FDA https://files.sld.cu/eticaeninvestigacion/2022/12/12/bioresearch-monitoring-program-bimo-institutional-review-board-fda/ https://files.sld.cu/eticaeninvestigacion/2022/12/12/bioresearch-monitoring-program-bimo-institutional-review-board-fda/#comments Mon, 12 Dec 2022 20:44:56 +0000 http://files.sld.cu/eticaeninvestigacion/?p=97 Bioresearch Monitoring Program (BIMO) – Institutional Review Board. FDA

]]> https://files.sld.cu/eticaeninvestigacion/2022/12/12/bioresearch-monitoring-program-bimo-institutional-review-board-fda/feed/ 0 CPGM for Institutional Review Boards. FDA https://files.sld.cu/eticaeninvestigacion/2022/12/12/cpgm-for-institutional-review-boards-fda/ https://files.sld.cu/eticaeninvestigacion/2022/12/12/cpgm-for-institutional-review-boards-fda/#comments Mon, 12 Dec 2022 20:40:40 +0000 http://files.sld.cu/eticaeninvestigacion/?p=94 CPGM for Institutional Review Boards. FDA

]]> https://files.sld.cu/eticaeninvestigacion/2022/12/12/cpgm-for-institutional-review-boards-fda/feed/ 0 Frequently Asked Questions – IRB Registration. FDA https://files.sld.cu/eticaeninvestigacion/2022/12/12/frequently-asked-questions-irb-registration-fda/ https://files.sld.cu/eticaeninvestigacion/2022/12/12/frequently-asked-questions-irb-registration-fda/#comments Mon, 12 Dec 2022 20:37:58 +0000 http://files.sld.cu/eticaeninvestigacion/?p=91 Frequently Asked Questions – IRB Registration. FDA

]]> https://files.sld.cu/eticaeninvestigacion/2022/12/12/frequently-asked-questions-irb-registration-fda/feed/ 0 IRB Continuing Review After Clinical Investigation Approval 2012 FDA https://files.sld.cu/eticaeninvestigacion/2022/12/12/irb-continuing-review-after-clinical-investigation-approval-2012-fda/ https://files.sld.cu/eticaeninvestigacion/2022/12/12/irb-continuing-review-after-clinical-investigation-approval-2012-fda/#comments Mon, 12 Dec 2022 20:29:07 +0000 http://files.sld.cu/eticaeninvestigacion/?p=85 IRB Continuing Review After Clinical Investigation Approval 2012 FDA

]]> https://files.sld.cu/eticaeninvestigacion/2022/12/12/irb-continuing-review-after-clinical-investigation-approval-2012-fda/feed/ 0 FDA-2008-Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs. Frecuently asked questions-statement of investigator (Form FDA 1572) https://files.sld.cu/eticaeninvestigacion/2022/12/12/fda-2008-information-sheet-guidance-for-sponsors-clinical-investigators-and-irbs-frecuently-asked-questions-statement-of-investigator-form-fda-1572/ https://files.sld.cu/eticaeninvestigacion/2022/12/12/fda-2008-information-sheet-guidance-for-sponsors-clinical-investigators-and-irbs-frecuently-asked-questions-statement-of-investigator-form-fda-1572/#comments Mon, 12 Dec 2022 19:29:56 +0000 http://files.sld.cu/eticaeninvestigacion/?p=79 FDA-2008-Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs. Frecuently asked questions-statement of investigator (Form FDA 1572)

]]> https://files.sld.cu/eticaeninvestigacion/2022/12/12/fda-2008-information-sheet-guidance-for-sponsors-clinical-investigators-and-irbs-frecuently-asked-questions-statement-of-investigator-form-fda-1572/feed/ 0 FDA. Guidance for Clinical Investigators, Sponsors, and IRBs – Adverse Event Reporting to IRBs ­ Improving Human Subject Protection 2009 https://files.sld.cu/eticaeninvestigacion/2022/12/12/guidance-for-clinical-investigators-sponsors-and-irbs-adverse-event-reporting-to-irbs-%c2%ad-improving-human-subject-protection-2009/ https://files.sld.cu/eticaeninvestigacion/2022/12/12/guidance-for-clinical-investigators-sponsors-and-irbs-adverse-event-reporting-to-irbs-%c2%ad-improving-human-subject-protection-2009/#comments Mon, 12 Dec 2022 19:19:18 +0000 http://files.sld.cu/eticaeninvestigacion/?p=75 Guidance for Clinical Investigators, Sponsors, and IRBs – Adverse Event Reporting to IRBs ­ Improving Human Subject Protection 2009

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