Common use of Audit by Regulatory Agency Clause in Contracts

Audit by Regulatory Agency. If a regulatory agency wishes to audit Institution or Investigator in connection with the Trial, Institution and Investigator agree to (a) promptly notify Sponsor and any Sponsor designee(s) of such audit and allow Sponsor and/or its designee(s) to reasonably participate in the audit preparation and performance, including reviewing documentation to be provided to the regulatory agency; and (b) cooperate with the regulatory agency, comply with the legitimate requirements of the audit, and make appropriate Trial Staff available to explain and discuss records and documentation related to the Trial.

Audit by Regulatory Agency. If a regulatory agency wishes to audit Institution or Investigator in connection with the TrialStudy, Institution and Investigator agree to (a) to promptly notify Sponsor thereof and any Sponsor designee(s) of such audit and allow use their best efforts to obtain approval for Sponsor and/or its designee(s) to reasonably participate in the audit preparation and performance, including reviewing documentation designees to be provided to present at the regulatory agency; audit, and (b) to cooperate with the regulatory agency, comply with the legitimate requirements of the audit, and to use best their efforts to make appropriate Trial Staff personnel available to explain and discuss records and documentation related to the TrialStudy.

Audit by Regulatory Agency. If a regulatory agency wishes to audit Institution or Investigator in connection with the TrialStudy, Institution and Investigator agree to (a) to promptly notify Sponsor thereof and any Sponsor designee(s) of such audit and allow use their best efforts to obtain approval for Sponsor and/or its designee(s) to reasonably participate in the audit preparation and performance, including reviewing documentation designees to be provided to present at the regulatory agency; audit, and (b) to cooperate with the regulatory agency, comply with the legitimate requirements of the audit, and make appropriate Trial Staff personnel available to explain and discuss records and documentation related to the TrialStudy.

Audit by Regulatory Agency. If a regulatory agency wishes to audit Institution or Investigator in connection with the TrialStudy, Institution and Investigator agree agrees to (a) promptly notify Sponsor and any Sponsor designee(s) of such audit and allow Sponsor and/or its designee(s) designees to reasonably participate in the audit preparation and performancepreparation, including reviewing documentation to be provided to the regulatory agency; and (b) cooperate with the regulatory agency, comply with the legitimate requirements of the audit, and make appropriate Trial Staff Study Personnel available to explain and discuss records and documentation related to the TrialStudy.