tagPlaceholderTags: health, product, market, clinical, trial, medical, device, FDA, investigation, quality, drug, access, IND, IDE, biologic, CRO, electronic, record, EHR, sponsor, IRB, ERB, REB, EDC, eCRF, computer, system, validation, e-record, e-signature, IT, certification, ONC, controls, audit, trails, informed, consent, inspection, retention, data, privacy, confidentiality, secure, authorized, interoperability, combination, foreign, studies, FEB2017