Common use of STUDY DOCUMENTATION AND ARCHIVE Clause in Contracts

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.

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, 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, radiology and records; , subject diaries; , microfiches; correspondence; , correspondence and death registries. CRF Case report form entries may be considered as source data if the site of the original data collection is not available. However, 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 centralize filing system of all subject records that are readily retrieved to be monitored and/or and or audited at any time by the key sponsor contact, regulatory authorities, authorities and IRB/IECs. The filing system will include at minimum:  Subject content including ICFs and subject ID identification lists  Protocols and protocol amendments, IBinvestigator brochure, copies of pre-study documentation, and all IRB/IEC and sponsor communication  Proof of receipt, experimental treatment flow records, records and experimental product-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 Pharma 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.

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, 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, radiology and records; , subject diaries; , microfiches; correspondence; , correspondence and death registries. CRF Case report form entries may be considered as source data if the site of the original data collection is not available. However, 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 centralize filing system of all subject records that are readily retrieved to be monitored and/or and or audited at any time by the key sponsor contact, regulatory authorities, authorities and IRB/IECs. The filing system will include at minimum:  • Subject content including ICFs and subject ID identification lists  • Protocols and protocol amendments, IBinvestigator brochure, copies of pre-study documentation, and all IRB/IEC and sponsor communication  • Proof of receipt, experimental treatment flow records, records and experimental product-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 Pharma 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.

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.