In developing a compliance application based on the institutional review board policies of John Hopkins’ Dept. of Medicine, we have to clarify the following sentence:
- Projects involving drugs or medical devices other than the use of an approved drug or medical device in the course of medical practice and projects whose data will be submitted to or held for inspection by the FDA will not be exempt from JHM IRB review UNLESS that use falls within the Emergency Use provisions of 21 CFR 56.102 (d).
As you can see, there are a number of compound words and acronyms, as well as references to the Code of Federal Regulations that need to be defined or recognized to understand this sentence. Continue reading “Knowledge acquisition using lexical and semantic ontology”