Common use of Record Management Clause in Contracts

Record Management. 2.4.1 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 the longer of (a) two (2) years after the last marketing authorization for the Study Product has been approved or Sponsor has discontinued research on the Study Product or (b) such longer period as required by regulatory requirements. Sponsor will provide instructions for the retention or destruction of documentation. 2.4.2 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. 2.4.3 Institution/Principal Investigator shall keep all related correspondences by the Institution/Principal Investigator, the Institution's employees, Sponsor and any other person involved in the Study in accordance with Section 2.4.1. 2.4.4 Institution/Principal Investigator shall maintain accurate data collection and up-to-date records of all Study subjects; 2.4.5 Institution/Principal Investigator shall record and evaluate all Adverse Events experienced by the Study subjects in accordance with the Protocol.