As part of the FDA's and the HHS Office for Human Research Protections' initiative of issuing regulations instead of guidances for clinical trials, they are working on a final rule for registering institutional review boards (IRBs). Existing FDA regulations do not take into account all the different types of organizations involved in conducting clinical trials and also fail to take account for electronic data issues, data standardization, electronic health records, electronic patient-reported outcomes and electronic case report forms.

For more information, please see:

http://www.fdanews.com/newsletter/article?issueId=11571&articleId=106581