Common use of Audits by Regulatory Authorities Clause in Contracts

Audits by Regulatory Authorities. The Institution/Principal Investigator shall provide the Sponsor prompt, advance notification of any audit by a regulatory authority, which audit is directly related to the Study (or, when advance notification is impracticable, prompt notification of any completed audit). To the extent possible, the Institution/Principal Investigator shall permit the Sponsor to review and comment in advance on any written communication from the Institution/Principal Investigator to the regulatory authority in connection with such an audit; provided, however, that such review does not have a material adverse impact on the timeliness of the Institution/Principal Investigator’s response to the regulatory authority. The Institution/Principal Investigator shall promptly provide the Sponsor with copies of all communications between the Institution/Principal Investigator and the regulatory authority related to such audit unless prohibited from so doing by the regulatory authority, and shall promptly take action to correct any deficiencies found by the regulatory authority during the audit. With respect to a pending audit directly related to the Study by the FDA or by any comparable foreign regulatory authority with jurisdiction over drug approval, the Institution/Principal Investigator shall permit the Sponsor’s representatives to be present at such audit unless prohibited from so doing by Applicable Law. With respect to any audit by any regulatory authority, which audit is not directly related to the Study, the hlavní zkoušející a zdravotnické zařízení ihned kroky k nápravě těchto porušení a zadavateli poskytnou potvrzení o těchto krocích k nápravě.

Audits by Regulatory Authorities. The Institution/Principal Investigator Institution shall provide the Sponsor prompt, advance notification of any audit by a regulatory authority, which audit is directly related to the Study (or, when advance notification is impracticable, prompt notification of any completed audit). To the extent possible, the Institution/Principal Investigator Institution shall permit the Sponsor to review and comment in advance on any written communication from the Institution/Principal Investigator to designated for the regulatory authority in connection with such an audit; provided, however, that such review does not have a material adverse impact on the timeliness of the Institution/Principal Investigator’s response to the regulatory authority. The Institution/Principal Investigator Institution shall promptly provide the Sponsor with copies of all communications between the Institution/Principal Investigator Institution and the regulatory authority related to such audit unless prohibited from so doing by the regulatory authority, and shall promptly take action to correct any deficiencies found by the regulatory authority during the audit. With respect to a pending audit directly related to the Study by the FDA or by any comparable foreign regulatory authority with jurisdiction over drug approval(e.g. SÚKL), the Institution/Principal Investigator Institution shall permit the Sponsor’s representatives to be present at such audit unless prohibited from so doing by Applicable Law. With respect to any audit by any regulatory authority, which audit is not directly related to the Study, the hlavní zkoušející a zdravotnické zařízení ihned kroky k nápravě těchto porušení a zadavateli poskytnou potvrzení o těchto krocích k nápravěInstitution shall promptly notify the Sponsor of any findings of such an audit that may have an adverse effect on the Institution’s ability to conduct the Study in accordance with the Protocol or Applicable Law.

Audits by Regulatory Authorities. The Institution/Principal Investigator Institution shall provide the Sponsor prompt, advance notification of any audit by a regulatory authority, which audit is directly related to the Study (or, when advance notification is impracticable, prompt notification of any completed audit). To the extent possible, the Institution/Principal Investigator Institution shall permit the Sponsor to review and comment in advance on any written communication from the Institution/Principal Investigator Institution to the regulatory authority in connection with such an audit; provided, however, that such review does not have a material adverse adversely impact on the timeliness of the Institution/Principal Investigator’s response to the regulatory authority. The Institution/Principal Investigator Institution shall promptly provide the Sponsor with copies of all communications between the Institution/Principal Investigator Institution and the regulatory authority related to such audit unless prohibited from so doing by the regulatory authority, and shall promptly take action to correct any deficiencies found by the regulatory authority during the audit. With respect to a pending audit directly related to the Study by the FDA or by any comparable foreign regulatory authority with jurisdiction over drug drug/device approval, the Institution/Principal Investigator Institution shall permit the Sponsor’s representatives to be present at such audit unless prohibited from so doing by Applicable Lawthe FDA or such foreign regulatory authority. With respect to any audit by any regulatory authority, which audit is not directly related to the Study, the hlavní zkoušející a zdravotnické zařízení ihned kroky k nápravě těchto porušení a zadavateli poskytnou potvrzení o těchto krocích k nápravěInstitution shall promptly notify the Sponsor of any findings of such an audit that would be likely to have an adverse effect on the Institution’s ability to conduct the Study.