12/12/2022
Comentarios desactivados
Detailed guidance on the application format and documentation to be submitted to a Ethics Committee for medicinal products for clinical Trials. EC
Comentarios desactivados
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
Comentarios desactivados
Ethical considerations for clinical trials on medicinal products conducted with the pediatric population
Comentarios desactivados
Bioresearch Monitoring Program (BIMO) – Institutional Review Board. FDA
Comentarios desactivados
CPGM for Institutional Review Boards. FDA
Comentarios desactivados
Frequently Asked Questions – IRB Registration. FDA
Comentarios desactivados
IRB Continuing Review After Clinical Investigation Approval 2012 FDA
Comentarios desactivados
FDA-2008-Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs. Frecuently asked questions-statement of investigator (Form FDA 1572)
Comentarios desactivados
FDA. Guidance for Clinical Investigators, Sponsors, and IRBs – Adverse Event Reporting to IRBs Improving Human Subject Protection 2009
Comentarios desactivados