Site Audits Clause Samples

Site Audits. Representatives of the IRB or the Sponsor (or designee) may visit the study site to carry out an audit of the study in compliance with regulatory guidelines and company policy. Such audits will require access to all study records including source documents, CRFs, and other study documents. Direct access to these study records must be guaranteed by the Investigator, who must provide support for these activities at all times. Similar auditing procedures may also be conducted by agents of any Regulatory Authority reviewing the results of this study. The Investigator/institution should immediately notify the Sponsor if they have been contacted by a Regulatory Authority concerning an upcoming inspection. Accountability for the study medication at the study site is the responsibility of the Investigator. The Investigator will ensure that the study medication is used only in accordance with this protocol. Where allowed, the Investigator may choose to assign some of the study medication accountability responsibilities to a pharmacist or other appropriately trained individual. Study medication accountability records indicating the delivery date to the study site, inventory at the study site and dispensing/use will be maintained. These records will adequately document that the study medications were dispensed and returned as specified in the protocol and according to the randomization scheme. Accountability records for all study medications will include dates, quantities, batch/lot numbers, kit numbers, cartridge numbers, and patient numbers. The Sponsor (or its designee) will review study medication accountability records at the study site on an ongoing basis during the study. All used and unused supplies must be inventoried, accounted for, and returned to the Sponsor (or its designee), or if authorized, disposed of at the study site. Records of disposal must be maintained with the study records.

Site Audits. The City will reserve the right to do periodic Site Audits of the awarded Service Provider, if deemed necessary.

Site Audits. ONCORE will allow ZELTIQ to perform quality assurance inspections and audits of ONCORE’s facility(ies) during regular business hours upon five (5) business days advance written notice to ONCORE. ONCORE will cooperate with ZELTIQ inspector and will provide ZELTIQ access to ONCORE’s files (electronic or paper) to properly perform any such inspection or audit. The audit may include records relating to manufacturing compliance with the applicable Specifications, compliance with quality control and, inspection reports procedures, design history requirements, compliance with US FDA GMP/QSR Regulations, regulatory compliance, CE ▇▇▇▇ certification records and procedures, and compliance with ISO and/or EN requirements as applicable.

Site Audits. ▇▇▇▇▇▇▇ (through ▇▇▇▇▇▇▇ R&D Global Research & Development Quality Assurance or any successor organization responsible for quality assurance for ▇▇▇▇▇▇▇ and its Affiliates) will be responsible for establishing audit plans for each clinical study assigned to a Party in the CDP. The provisions of Section 7.4.2 below shall govern audits of sites Manufacturing clinical supplies of Licensed Products.

Site Audits. Supplier will have, at a minimum, an annual site audit of Supplier's Information Technology general controls including, but not limited to, information security, privacy, and confidentiality controls, performed by a recognized third-party audit firm, which shall be provided to Ameren within thirty (30) days of its completion. The audit shall comply with the requirements of the American Institute of Certified Public Accountants' (AICPA) attestation standards SSAE 18, or the equivalent standard recognized by the industry at the time of such report (the "SOC Report"). The SOC Report shall include both a Type I report and a Type II report, upon Ameren's written request. Ameren reserves the right to request additional site audits if a SOC Report has revealed a security issue, or a security incident involving Supplier has been identified, which Supplier shall complete within sixty (60) days from the date requested. Any control exceptions noted in the SOC Report or equivalent will be addressed in the report with management’s corrective action. The SOC Report shall be performed by a recognized third-party audit firm engaged by Supplier. Supplier shall provide Ameren with the results of each SOC Report with respect to Supplier's security measures relating to electronic data at all facilities where Ameren Data is stored or accessed during the term of this Contract, regardless of the location of such facilities: a. Supplier shall provide a copy of the related report and consents to the provision of copies of such report by Ameren to applicable regulators. b. The report or attestation shall contain Supplier's management’s response to the exception comments, if any are noted, together with appropriate target dates for completion of required changes. Supplier shall provide reasonable assistance to Ameren in meeting its audit and regulatory requirements relating to electronic data and system security, including: a. providing access to relevant books, records, and Ameren Data in Supplier's possession; b. permitting a narrated data center tour; and c. permitting auditors and examiners to conduct reviews via submitting questionnaires after any security breach that has or is likely to result in an unauthorized use or disclosure of Ameren Data, or the systems that house or handle such Ameren Data.

Site Audits. Contractor shall conduct detailed site audits that thoroughly document and verify the existing conditions that will inform the system design and construction. Site Audits will be used to verify impacts to site the Site(s) as part of the construction project and shall be conducted within 21 days of Contract execution. It is the responsibility of the Contractor to document all existing conditions and demonstrate that the post-construction site conditions are equivalent to pre-construction conditions.