Common use of Case Report Forms and Records Clause in Contracts

Case Report Forms and Records. Collaborator shall own the original, completed Case Report Forms and the CRADA Data. VA must retain copies. Collaborator acknowledges that the CRADA Data may be replicated in VA-owned patient medical records. Collaborator ownership of CRADA Data in no way limits VA’s ownership and use of data in its medical records. Except data contained in the Case Report Forms and the CRADA Data, patient medical records, Individually Identifiable Information, original notes, documents, and records created by VA in the course of performing the SOW shall be the property of VA. Collaborator shall have access to such materials solely for auditing and compliance purposes as described in Section 3.7. VA is responsible for protecting the confidentiality and security of data and information gathered in the course of this CRADA according to applicable Federal statutes, regulations, and VA policies. VA will ensure the secure transfer of the data to the Collaborator. Collaborator is responsible for protecting the confidentiality and security of VA-provided data and information under its control.

Case Report Forms and Records. Collaborator shall own the original, completed Case Report Forms and the CRADA Data. ; VA must retain copies. Collaborator acknowledges that the CRADA Data may be replicated in VA-owned patient medical records. Collaborator ownership of CRADA Data in no way limits VA’s ownership and use of data in its medical records. Except data contained in the Case Report Forms and the CRADA Data, patient medical records, Individually Identifiable Information, original notes, documents, and records created by VA in the course of performing the SOW shall be the property of VA. Collaborator shall have access to such materials solely for auditing and compliance purposes as described in Section 3.7. VA is responsible for protecting the confidentiality and security of data and information gathered in the course of this CRADA according to applicable Federal statutes, regulations, and VA policies. VA will ensure the secure transfer of the data to the Collaborator. Collaborator is responsible for protecting the confidentiality and security of VA-provided data and information under its control.