Common use of Monitoring and Auditing Clause in Contracts

Monitoring and Auditing. 7.1. Site visits by Sponsor and/or its authorized designee (e.g., Study monitor) will be scheduled in advance for times mutually acceptable to the Parties during normal business hours. Sponsor’s and/or authorized designee’s access is subject to reasonable safeguards to ensure confidentiality of medical records and systems. 7.2. Upon becoming aware of an audit or investigation by a regulatory agency with jurisdiction over the Study, Institution agrees to provide Sponsor with prompt notice of the auditor investigation. If legally permissible or allowable by the regulatory agency and permissible in accordance with the Institution’s policy, Sponsor may be available or request to be present with approval from auditor during such audit, but Sponsor agrees not to alter or interfere with any documentation or practice of Institution. Institution shall be free to respond to any regulatory agency inquiries and will provide Sponsor with a copy of any formal response or documentation to the regulatory agency regarding the Study.

Monitoring and Auditing. 7.1. Site visits by Sponsor and/or its authorized designee (e.g., Study monitor) will be scheduled in advance for times mutually acceptable agreeable to the Parties during normal business hours. Sponsor’s and/or authorized designee’s access is subject to reasonable safeguards to ensure confidentiality of medical records and systems. Sponsor or CRO representatives shall complete the Institution’s Guest Account Request Form in order to access the Institution’s electronic medical records. 7.2. Upon becoming aware of an audit or investigation by a regulatory agency with jurisdiction over the Study, Institution agrees to provide Sponsor with prompt notice of the auditor investigation. If legally permissible or allowable by the regulatory agency and permissible in accordance with the Institution’s policy, Sponsor may be available or request to be present with approval from auditor during such audit, but Sponsor agrees not to alter or interfere with any documentation or practice of Institution. Institution shall be free to respond to any regulatory agency inquiries and will provide Sponsor with a copy of any formal response or documentation to the regulatory agency regarding the Study.

Monitoring and Auditing. 7.1. Site visits by Sponsor Sponsor, CRO and/or its another authorized designee (e.g., Study monitor) will be scheduled in advance for times mutually acceptable to the Parties during normal business hours. Sponsor’s, CRO’s and/or authorized designee’s access is subject to reasonable safeguards to ensure confidentiality of medical records and systems. Sponsor and/or its authorized designee must comply with Institution’s visitor rules when on site at Institution. 7.2. Upon becoming aware of an audit or investigation by a regulatory agency with jurisdiction over the Study, Institution agrees to provide Sponsor with prompt notice of the auditor investigation. If legally permissible or allowable by the regulatory agency and permissible in accordance with the Institution’s policy, Sponsor may be available or request to be present with approval from auditor during such audit, but Sponsor agrees will not to alter or interfere with any documentation or practice of Institution. Institution shall be free to respond to any regulatory agency inquiries and will provide Sponsor with a copy of any formal response or documentation to the regulatory agency regarding the Study.