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Case Report Forms The case report forms that will be used to collect the data from each subject in this clinical study. These case report forms will be kept at the USF site for storage during the trial. The study sponsor may receive copies of these forms for their records. Research Personnel Training & Certification All research staff participating in this trial will be up to date on the Human Protections training. Evidence of training (copies of completion certificates) will be kept in regulatory files by the testing site. In addition, all staff completing cognitive assessments and subject/study partner interviews for the screening and evaluation visits at USF will have been certified within the last 2 years by other Alzheimer’s disease research studies. Any testing site staff who has not been certified will go through the certification process prior to administering any assessments in this research study. |
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