Common use of Case Report Forms and Study Data Clause in Contracts

Case Report Forms and Study Data. a) The Investigator shall record all data resulting from the Study (the “Study Data”) in an accurate, legible and complete manner. The Institution acknowledges and agrees that the Sponsor shall own all Study Data and Study results. b) The Sponsor shall ensure access to the electronic case report forms to be used and completed by the Investigator (the “CRFs”). The Investigator shall ensure that the CRFs are duly completed, signed and dated in a timely manner c) The Institution shall ensure that it has implemented and maintains appropriate measures to protect the confidentiality, integrity and availability of Study Data and to prevent the loss, alteration and unauthorized access.

Case Report Forms and Study Data. a) The Investigator shall record all data resulting from the Study (the “Study Data”) in an accurate, legible and complete manner. The Institution acknowledges and agrees the Investigator acknowledge and agree that the Sponsor shall own all Study Data and Study results. b) The Sponsor shall ensure access to the electronic case report forms to be used and completed by the Investigator (the “CRFs”). The Investigator shall ensure that the CRFs are duly completed, signed and dated in a timely manner c) The Institution and the Investigator shall ensure that it has they have implemented and maintains maintained appropriate measures to protect the confidentiality, integrity and availability of Study Data and to prevent the loss, alteration and unauthorized access.