Common use of Study Records Clause in Contracts

Study Records. 6.1 Case Report Forms will be provided to the Investigator along with Study supplies. The Investigator shall complete and review all Case Report Forms for completeness and accuracy, shall submit data in a timely manner and shall maintain complete records of patient identification, clinical observations and clinical supplies disposition. The Investigator shall also maintain independent case histories for each patient, in addition to the Case Report Forms provided to the Investigator. The Investigator is required to retain Study documents and maintain the master patient log in accordance with all applicable regulations. 6.2 THE INVESTIGATOR SHALL RECORD ALL ENTRIES ON CASE REPORT FORMS IN A TIMELY MANNER FOLLOWING EACH PATIENT VISIT. 6.3 The Study will have quality assurance audits that will be performed several times during the duration of the Study. During the term of this Agreement, the Institution and Investigator agree to permit representatives of POI and Sponsor to examine at any reasonable time during normal business hours (1) the facilities where the Study is being conducted, (2) raw Study data, and (3) any other relevant information (and to make copies) necessary for POI or Sponsor to confirm that the Study is being conducted in conformance with the Protocol and in compliance with applicable laws, regulations and regulatory guidelines. The applicable health regulatory authority also may conduct independent inspections of the Study under its jurisdiction. The Investigator and Institution shall cooperate fully in such audits and inspections.