- NIH Single IRB
NIH Single IRB Policy FAQ
- The National Institutes of Health (NIH) and Food and Drug Administration (FDA) are developing a template with instructional and sample text for investigators to use in writing ls that require Investigational New Drug application (IND) or Investigational Device Exemption (IDE) applications. The agencies’ goal is to encourage and make it easier for investigators to prepare protocols that are consistently organized and contain all the information necessary for the clinical trial to be properly reviewed. The draft template follows the International Conference on Harmonisation (ICH) E6 Good Clinical Practice. This template may also be used as a guide for other types or phases of studies. Link for resources for writing protocols and information about other trial related documents.
Data Monitoring Committees — Expect the Unexpected
- The Cushing/Whitney Medical Library has recently licensed Pharmaprojects from Informa PLC. Pharmaprojects lets researchers track the progress of drugs from bench to patient by exploring drug development by global and country development status, and therapeutic class status. Further information on this resource, and how to access it, is located on the Medical Library's web site: http://library.medicine.yale.edu/blog/medical-library-bioinformatics/track-drugs-bench-patient-pharmaprojects