Institution and Investigator. shall (a) keep a detailed and written inventory of all clinical supplies and Study Drug provided by SPONSOR or CRO or its Affiliates and shall store such materials according to the Protocol or Study Instructions and (b) retain all necessary Subject records and/or documents whether electronic, paper, or in any other form relating to the Study for fifteen (15) years after the end or the premature termination of the Study. Institution and Investigator shall provide to CRO or its Affiliates all study data collected on case report forms as instructed by CRO.
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Institution and Investigator. shall (a) keep a detailed and written inventory of all clinical supplies supplies, equipment and Study Drug provided by SPONSOR or CRO or its Affiliates or SPONSOR and shall store such materials according to the Protocol or Study Instructions and (b) retain all necessary Subject records and/or documents whether electronic, paper, or in any other form relating to the Study in a secure manner with physical and electronic access restrictions, and environmental controls appropriate to the applicable data type and in accordance with applicable industry standards for fifteen (15) years after the end or the premature termination of the Study. The Institution and Investigator shall provide to CRO or its Affiliates all study data collected on case report forms as instructed by CRO.archive Study related documents
Appears in 1 contract
Samples: Contract
Institution and Investigator. shall (a) keep a detailed and written inventory of all clinical supplies supplies, equipment and Study Drug provided by SPONSOR or CRO or its Affiliates and shall store such materials according to the Protocol or Study Instructions and (b) retain all necessary Subject records and/or documents whether electronic, paper, or in any other form relating to the Study for fifteen (15) years after the end or the premature termination of the Study. Institution and Investigator shall provide to CRO or its Affiliates all study data collected on case report forms as instructed by CRO.
Appears in 1 contract
Samples: Clinical Research Agreement
Institution and Investigator. shall (a) keep a detailed and written inventory of all clinical supplies supplies, equipment and Study Drug Product provided by SPONSOR or CRO or its Affiliates and shall store such materials according to the Protocol or Study Instructions and (b) Investigator shall retain all necessary Subject records including the list of Subject’s identification codes, and/or documents whether electronic, paper, or in any other form relating to the Study for fifteen (15) years after the end or the premature termination of the Study. Institution and Investigator shall provide to CRO or its Affiliates all study data collected on case report forms as instructed by CRO.
Appears in 1 contract
Samples: Clinical Trial Agreement
Institution and Investigator. shall (a) keep a detailed and written inventory of all clinical supplies supplies, equipment and Sponsor Study Drug provided by SPONSOR Sponsor or CRO or its Affiliates and shall store such materials according to the Protocol or Study Instructions and (b) retain all necessary Subject records Study Documentation, including without limitation the informed consent forms and other documentation pertaining to the Subjects, and/or documents whether electronic, paper, or in any other form relating to the Study for fifteen (15) years after the end or the premature termination of the Study. Institution and Investigator shall provide to CRO or its Affiliates all study data collected on case report forms as instructed by CRO.Study and
Appears in 1 contract
Samples: Global Clinical Site Agreement
Institution and Investigator. shall (a) keep a detailed and written inventory of all clinical supplies supplies, equipment and Study Drug provided by SPONSOR or CRO or its Affiliates and shall store such materials according to the Protocol or Study Instructions and (b) retain all necessary Subject records and/or documents whether electronic, paper, or in any other form relating to the Study for fifteen (15) years after the end or the premature termination of the Study. Institution and Investigator shall provide to CRO or its Affiliates all study data collected on case report forms as instructed by CRO.
Appears in 1 contract
Samples: Clinical Research Agreement