; and (ii) raw data, such as tabulations of data and results as required under section 814.20(b)(6)(ii) of title 21, Code of Federal Regulations (or any successor regulations); (iii) for nonclinical laboratory studies involving the test, a statement that studies were conducted in compliance with applicable good laboratory practices; and (iv) for investigations involving human subjects, statements that any clinical investigation involving human subjects was conducted in compliance with applicable— (I) institutional review board regulations; (II) informed consent regulations