Guías, manuales y herramientas
2023
2016
2012
2011
- A Review of the Availability of Information on Ethics Committee Requirements for Clinical Trials in the EU. EC (pdf)
- Reflection paper on the need for active control in therapeutic areas where use of placebo is deemed ethical and one or more established medicines are available. EMEA (pdf)
- Compliance Program Guidance Manual for Institutional Review Boards. FDA (pdf)
2009
- Guidance for Clinical Investigators, Sponsors, and IRBs – Adverse Event Reporting to IRBs Improving Human Subject Protection. FDA (pdf)
- Frequently Asked Questions – IRB Registration. FDA (pdf)
2008
2006
2001
1994