STUDY MONITORING AND DATA COLLECTION Sample Clauses

STUDY MONITORING AND DATA COLLECTION. A representative from the Sponsor will visit the study center periodically to monitor adherence to the protocol and applicable FDA regulations, and the maintenance of adequate and accurate clinical records. CRFs are reviewed to ensure that key safety and efficacy data are collected and recorded as specified by the protocol. The Sponsor's representative (or designate) is permitted to access patient medical records, laboratory data and other source documentation as needed to appropriately monitor the trial.

STUDY MONITORING AND DATA COLLECTION. The key sponsor contact, monitors, auditors, or regulatory inspectors are responsible for contacting and visiting the investigator for the purpose of inspecting the facilities and verifying source documents and records assuring that subject confidentially is respected. The monitor is responsible for source document verification of CRF data at regular intervals during the study. Protocol adherence, accuracy, and consistency of study conduct and data collection with respect to local regulations will be confirmed. Monitors will have access to subject records as identified in Section 13. By signing the Investigator’s Agreement, the investigator agrees to cooperate with the monitor to address and resolve issues identified during monitoring visits. In accordance with ICH/GCP and the audit plan, a site may be chosen for a site audit. A site audit would include, but is not limited to, an inspection of the facility(ies), review of subject and study-related records, and compliance with protocol requirements as well as ICH/GCP and applicable regulatory policies. All data will be collected in an electronic CRF system. All entries must be completed in English, and concomitant medications should be identified by tradenames. For further details surrounding the completion of CRFs, refer to the CRF completion guidelines.