GCP: A Question & Answer Reference Guide Table F STUDY FILE (for each ongoing study) Investigator Brochure CV of Principal Investigator and Co Investigators Entire project originally approved Letter of approval Initial project Submission for approval of amendments to the project Letter of Approval to the amendments to the project Template of Informed Consent Form (all versions) Approval of the first Informed Consent Submission for approval of Amendments to Originally Approved ICF Approval or following versions of ICF Information for Participating Subjects Approval of Materials for Participating subjects Recruitment materials Approval of recruitment materials Financial Aspects: study budget Insurance Policy for Participating Subjects Contract between Investigator and Institution Copy of Correspondence with Investigators containing decisions and recommendations Approval of Incentives and compensation to subjects not foreseen in previous revisions Approval of Annual Project Report Adverse Event Notification Project Deviation and Violations Notification Final Project Report 668