definiens: or means a set of investigational site - specific regu latory documents such as, to the extent required by the ap plicable Regulatory Authority : Form FDA 1572 ( or an equivalent document used in a region ( including Reg ion ) or country ( including Country ) in the Territor y that identifies any relationships that pose a potential conflict of interest for an investigator or other p erson whose responsibilities are critical to conduct of a clini cal trial ), principal investigator curriculum vitae, signed protocol signature page, site - specific ICF / IAF ( back - transla ted into English if the local language is other tha n English ), investigator brochure, clinical trial agreement, cl inical trial approval, IRB / IEC approval, study site qualification documents, privacy requirements ( e.g., HIPAA ), IRB/ IEC membership, and other country ( including Countr y)-specific or region ( including Region)-specific requ irements