Common use of Study Monitoring Clause in Contracts

Study Monitoring. A representative from Light Sciences Oncology or designated CRO will visit the study center periodically to monitor adherence to the protocol, adherence to applicable FDA regulations, and the maintenance of adequate and accurate clinical records. CRFs will be reviewed to ensure that key safety and efficacy data are collected and recorded as specified by the protocol. The LSO or designated CRO representative will be permitted to access patient medical records, laboratory data, and other source documentation as needed to appropriately monitor the trial. The Investigator should allocate adequate time for these visits.