Common use of Collection and Storage of Data Clause in Contracts

Collection and Storage of Data. With respect to the Study subject’s medical files, the parties agree to exercise measures to hold in confidence the identity of Study subjects in accordance with applicable laws. In addition to any collection, security and storage provisions imposed under applicable laws, Institution shall ensure the prompt, complete, and accurate reporting and labeling of the Study Data, Source Records, and Inventory Data and shall cooperate with Sponsor and Sponsor representative in promptly resolving any data inquiries. Institution shall, and shall ensure that all Research Personnel maintain and store the Study Data, Source Records and Inventory Data 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. Institution shall, and shall ensure Research Personnel will protect the Study Data, Source Records and Inventory Data from unauthorized use, access, duplication, disclosure, loss or damage. Institution shall maintain all Study Data, Source Records and Inventory Data for the longer of fifteen (15) years or applicable legal requirements. Institution shall not, and shall ensure that Research Personnel do not destroy any Study Data, Source Records or Inventory Data without Sponsor’s prior written permission. Institution agrees to ensure that the Research Personnel maintains all versions of the Protocol in Institution’s Study files.

Appears in 3 contracts

Samples: Clinical Trial Research Agreement, Clinical Trial Research Agreement, Clinical Trial Research Agreement

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Collection and Storage of Data. With respect to the Study subject’s medical files, the parties agree to exercise measures to hold in confidence the identity of Study subjects in accordance with applicable laws. In addition to any collection, security and storage provisions imposed under applicable laws, Institution shall ensure the prompt, complete, and accurate reporting and labeling of the Study Data, Source Records, and Inventory Data and shall cooperate with Sponsor and Sponsor representative in promptly resolving any data inquiries. Institution shall, and shall ensure that all Research Personnel maintain and store the Study Data, Source Records and Inventory Data 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. Institution shall, and shall ensure Research Personnel will protect the Study Data, Source Records and Inventory Data from unauthorized use, access, duplication, disclosure, loss or damage. Institution shall maintain all Study Data, Source Records and Inventory Data for the longer of fifteen (15) years or applicable legal requirements. Institution shall not, requirements Sponsor has option of requesting and shall ensure that Research Personnel do not destroy any Study Data, Source Records or Inventory Data without Sponsor’s prior written permissionextension of archiving period before its end. Institution agrees to ensure that the Research Personnel maintains all versions of the Protocol in Institution’s Study files.

Appears in 1 contract

Samples: Clinical Trial Research Agreement

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