Database Management and Quality Control Sample Clauses

Database Management and Quality Control. ‌ Karyopharm personnel (or designated CRO) will review the eCRF data entered by investigational staff for completeness and accuracy. Electronic data queries stating the nature of the problem and requesting clarification will be created for discrepancies and missing values and sent to the investigational site via the electronic data capture (EDC) system. Designated Investigator site staff are required to respond promptly to queries and to make any necessary changes to the data. At the conclusion of the study, after discrepancies and missing values have been completed and the data have been verified to be complete and accurate, the database will be declared locked. For EDC studies, after database lock, the Investigator will receive a CD-ROM or paper copies of the patient data for archiving at the investigational site.
Sample 1
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