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 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. 1.4.2 Institution may store Study documents at a mutually agreed third party site at Sponsor’s expense. 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.
Appears in 8 contracts
Samples: Clinical Trial Agreement, Clinical Trial Agreement, Clinical Trial Agreement
