STUDY DOCUMENTATION AND ARCHIVE Sample Clauses

STUDY DOCUMENTATION AND ARCHIVE. The investigator will maintain a list of qualified staff to whom study responsibilities have been delegated. These individuals authorized to fulfil these responsibilities should be outlined and included in the Delegation of Authority Form. Source documents are original documents, data, and records for which the study data are collected and verified. Example of such source documents may include, but are not limited to, hospital records and patient charts; laboratory, pharmacy, radiology, and records; subject diaries; microfiches; correspondence; and death registries. CRF entries may be considered as source data if the site of the original data collection is not available. However, use of the CRFs as source documentation as a routine practice is not recommended. The investigator and study staff are responsible for maintaining a comprehensive and centralized filing system of all subject records that are readily retrieved to be monitored and/or audited at any time by the key sponsor contact, regulatory authorities, and IRB/IECs. The filing system will include at minimum:  Subject content including ICFs and subject ID lists  Protocols and protocol amendments, IB, copies of pre-study documentation, and all IRB/IEC and sponsor communication  Proof of receipt, experimental treatment flow records, and experimental product-related correspondence. Original source documents supporting entries into CRFs must be maintained at the site and readily available upon request. No study documents should be discarded without prior written agreement between Kite and the investigator. Should storage no longer be available to archive source documents or must be moved to an alternative location, the research staff should notify the key sponsor contact prior to the shipping the documents.

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STUDY DOCUMENTATION AND ARCHIVE. The investigator should maintain a list of appropriately qualified persons to whom he / she has delegated study duties. All persons authorized to make entries and / or corrections on eCRFs will be included on the Delegation of Authority Form. Source documents are original documents, data, and records from which the subject’s eCRF data are obtained. These include but are not limited to hospital records, clinical and office charts, laboratory and pharmacy records, images, microfiches, radiographs, and correspondence. The principal investigator will be responsible for ensuring that source documents are filed in a suitably secure location to ensure source data verification can be undertaken throughout the study. The investigator and study staff are responsible for maintaining a comprehensive and centralized filing system of all study-related (essential) documentation, suitable for inspection at any time by representatives from Opthea and / or applicable regulatory authorities. In addition, all original source documents supporting entries in the eCRFs must be maintained and be readily available. Following completion of the study the investigator will retain copies of the approved protocol, completed eCRFs, informed consent documents, relevant source documents, and all other supporting documentation related to the project in accordance with the applicable institutional review board, ethics committee, ICH and regulatory requirements (whichever is the longer). Documents must be retained for a minimum of 15 years from the date of termination of the study or for at least 2 years after the last approval of a marketing application in an ICH region, or at least 2 years after the formal discontinuation of the clinical development of an investigational product in accordance with local regulatory requirements. In the event that the investigator retires or relocates, custody of the records may be transferred to another suitable person who will accept responsibility for the records. Notice of such transfer should be given to Opthea in writing. The investigator must notify Opthea prior to destroying any study related documents.

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