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Privacy and Confidentiality Records for each subject in the pilot study will be maintained in separate files in a locked filing cabinet at the test site. The Principal Investigator will be responsible for ensuring that all records for a subject are stored in that subject’s file at all times other than when information is being recorded on them. Once a subject’s participation in the clinical study is complete and all of the required records are in the subject’s file, copies of the documents will be made and supplied to the study Sponsor who will then store them in a locked filing cabinet. Copies of subjects’ case report forms will also be sent to Regulatory Insight, Inc. for the purpose of monitoring the data collection process and analysis of results. Regulatory Insight, Inc. will also maintain these copies in a separate clinical study file that is kept in a locked filing cabinet. The original records will be maintained at the test site upon completion of the study in their original files. These files will be stored for a time period as defined per USF and IRB policy. Subjects’ identities will be kept confidential by assigning each subject a subject ID upon acceptance into the study. The subject ID will comprise the investigator’s first and last name initials and a three-digit number that will be determined based upon the subject’s order of entry into the study. For example, the eighth subject to be enrolled under Principal Investigator John Black would have a subject ID of JB008. Neither the study Sponsor nor Regulatory Insight, Inc. will receive any additional identifying information about a subject and will therefore have no way of linking a subject ID to a particular subject and his or her results. |
4700 140th Ave. N., Suite 101 • Clearwater, FL 33762 • 727-474-3722 |
