ABSTRACT
Department may still be forthcoming; and e. Ensure study site personnel understand record retention requirements for the
data.
3. Study files - To ensure completeness of the study records and documentation, the Monitor will inspect the Investigator's files. The Monitor will ensure: a. A signed copy of the informed consent form is present for each subject
enrolled in the study. Any irregularities concerning the informed consent forms which have not been previously documented will be discussed in the Study Termination Visit Trip Report.
