Study Monitoring, Data Collection and Quality Management Sample Clauses

Study Monitoring, Data Collection and Quality Management. Monitoring for this study will be conducted both during monitoring visits (both masked and unmasked) and via centralized review of eCRF data. The investigator will permit Opthea and their agents to monitor the study as frequently as Opthea deems necessary to determine that data recording and protocol adherence are satisfactory. A designated representative of Opthea in the form of a study monitor will verify participant data on the eCRFs for the purpose of analysis. The investigator will allow Opthea and their agents direct access to the related source documents for monitoring purposes as frequently as the sponsor deems necessary. This includes tests performed as a requirement for participation in this study and may also include other medical records required to confirm information contained in the eCRF such as past history and secondary diagnoses. At each participant visit, the Investigator or delegate should record all data generated since the last visit on the eCRF. The Investigator and his / her staff will be expected to cooperate with the monitor to assist in providing any missing information. The study monitor will require access to the investigator’s study file to ensure completeness of all study-related documentation. The date the study monitor visits the study site will be recorded in the site visit log. During monitoring visits, the study site co-coordinator and Investigator should be available, the source documentation will be accessible and a suitable environment will be provided for the study monitor to review study related documentation. The Opthea monitor is responsible for verifying the eCRFs at regular intervals throughout the study to verify adherence to the protocol; completeness, accuracy, and consistency of the data; and adherence to local regulations on the conduct of clinical research. The monitor should have access to subject medical records and other study-related records needed to verify the entries on the eCRFs. The key purposes for monitoring visits by the study monitor include the following: • Review of all study documentation for completion, adherence to the protocol • Notation of inconsistencies or missing data. • Ensuring all study materials are correctly stored and dispensed. • Verification of study data with source documents as per monitoring guidelines. • Checking fulfilment of the obligations of the Investigator. • Review of consent forms and date of consent. • Inspection of investigational product (storage, labelling and...
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