Source Records definition
Examples of Source Records in a sentence
Institution shall make, and shall ensure that Research Personnel make reasonable efforts to segregate, and not disclose, any Study Data, Inventions (as defined in Section 9.0), Source Records and other materials, correspondence and documents that are not required to be disclosed during such an inspection, including financial data and pricing information.
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, 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.
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 and Principal Investigator shall provide Sponsor with copies of all Study Data, Source Records, and any other materials, correspondence and documents which such party receives, obtains, or generates pursuant to any such inspection or in connection with any inquiries, communications or correspondence from any Agency.
Institution shall allow the Sponsor and Sponsor representative reasonable access to Institution and Research Personnel’s, as applicable, facilities and/or records to permit monitoring of the Study and reviewing, inspection and copying of Study Data, Source Records, Inventory Data, and signed Informed Consents and PHI consents, to the extent not prohibited by applicable law.
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 shall maintain all Study Data, Source Records and Inventory Data for the longer of fifteen (15) years or applicable legal requirements.
Institution shall provide Sponsor with copies of all Study Data, Source Records, and any other materials, correspondence and documents which such party receives, obtains, or generates pursuant to any such inspection or in connection with any inquiries, communications or correspondence from any Agency.
Third parties may obtain unauthorized access to the Services, including, but not limited to, your Digital Source Records.