Common use of Record Management Clause in Contracts

Record Management. 1.4.1 Institution/Principal Investigator will retain in a safe and secure location, one (1) copy of all printed and electronic data and reports resulting from the Study for such period as required by regulatory requirements. Sponsor will provide instructions for the period of retention or destruction of documentation. 1.4.2 Institution may store Study documents at a mutually agreed third party site at Sponsor’s expense. Such documents will only be accessed with the written consent of the Institution/Principal Investigator. In case of retrieval of the Study documents, stored on behalf of the Institution/Principal Investigator, prior written authorization is required. If the Institution/Principal Investigator wants to move the Study documents to another location, the Sponsor must be notified in writing. 1.4.3 Institution/Principal Investigator shall maintain accurate data collection and up-to-date records of all Study subjects.