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Source documents scored at each site within 7 days of assessment
CRFs also completed by psychometrist from scored source data with the same 7 days
CRFs will then be proofed, permitting on-site verification of data
Case Report Forms (CRFs) will then be entered into computer web-based system by
coordinators, with that data also being proofed by persons designated at each site
5.10.2 Functional Measures
Functional and Behavioral Sleep measures will be scored at DCC site from CRFs
containing individual responses entered by psychometrist
5.10.3 Data Storage
Source documents and copies of CRFs will be retained for up to five years after the end
of the study or until written notification is provided by the Executive Committee