Interim Monitoring Visits Sample Clauses

Interim Monitoring Visits. Aptiv Solutions will conduct initial interim site visit within two weeks after the first patient is enrolled at each site unless otherwise directed by Actinium; subsequent monitoring visits will be scheduled depending on enrollment rate and data quality. The frequency and length of visits will be adjusted as agreed upon by Actinium and Aptiv Solutions. Aptiv Solutions has assumed 12 one day (8 hours on-site) Interim Monitoring Visits per site. The monitoring plan can be written to allow the flexibility of more or fewer visits per site, as agreed upon with Actinium, as site-level enrollment warrants. The data quality will be reviewed after the first subject to identify any issues related to the protocol and retraining will occur, as applicable.
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Interim Monitoring Visits. STUDY MONITORING VISITS/SITE MANAGEMENT *Confidential treatment requested: Material has been omitted and filed with the Commission. WORK ORDER 1 CUBIST PHARMACEUTICALS, INC. DAP-CAP-00-08 ATTACHMENT I SCOPE OF WORK
Sample 1
Interim Monitoring Visits. Interim monitoring visits will be conducted at each Clinical Site at a regular frequency according to the study needs during enrollment and follow-up. Each visit can last anywhere from 6-8 hours and will be dependent upon the Clinical Site’s patient enrollment rates and the complexity of the source document verification. Between monitoring visits, the Clinical Research Associates (CRAs) will contact Clinical Sites to assess enrollment activity, answer study related questions, resolve queries and assist with any other issues regarding study conduct. This contact will occur every one to two weeks. If additional onsite interim monitoring visits are needed, InspireMD will be consulted for approval. Interim Site Visit Reports will be submitted to InspireMD following each visit. At the Interim Monitoring Visits the CRA will: · Assess enrollment and continuing protocol adherence; · Review all relevant source documents, in accordance with the Monitoring Plan; · Report any previously unreported SAEs to HCRI and InspireMD; · Investigate and resolve any outstanding queries; · Ensure that the investigational product is accounted for and that records are accurate; · Conduct a continuing review of the Investigator study file for regulatory adherence and to ensure that GCP/ICH guidelines are being followed, and · Perform 100% source documentation of the data entered, unless otherwise specified by InspireMD.
Sample 1
Interim Monitoring Visits. At each interim monitoring visit the ICON monitor will confirm site adherence to the protocol, confirm fulfillment of FDA requirements, verify CRFs against source documents, assure proper CRF completion, verify informed consents, ensure proper SAE reporting, record retention, adequacy of study supplies, proper study product storage and accountability. Closeout Visits (Including Un-Blinded) • At each site closeout visit the ICON monitor will perform complete study product reconciliation, verify that all CRFs are completed and monitored, and perform a review of investigator responsibilities (including record retention requirements, verification of investigator files for completeness and accuracy, and completion of the site closure form by the investigator). • After site closeout visit activities have been completed, ICON will send a closeout letter to the site; a record of relevant supplies and all documentation will also be forwarded to Genta or archived in accordance with relevant ICON SOPs. In-House Site Management • The ICON monitor will conduct in-house monitoring activities as needed during the study. • In-house site management activities will include site contact, generation of contact reports, site status tracking, attendance at team meetings, attendance at team training, responding to site questions, maintenance of updated investigator regulatory documents, issue resolution from previous site monitoring visits, responding to data queries, planning next visits (site contact documentation and travel plans), Serious Adverse Event (SAE) reporting and follow up and reconciliation as needed, generation of trip reports, creation of follow up letters documenting trip status, replenishing site supplies (i.e. case report forms, study product), responding to audit findings, assist as needed with mass distribution of information, and maintaining the investigator file. ICON will maintain telephone contact with sites on a regular basis throughout the study. Project Meetings • Regular project meetings will be held involving key team members from Genta and ICON in order to monitor study progress and address and resolve any problems that may be identified.
Sample 1

Related to Interim Monitoring Visits

  • Monitoring System In each case in which the Custodian has exercised delegated authority to place Assets with a Foreign Custodian, the Custodian shall establish a system, to re-assess or re-evaluate selected Foreign Custodians, at least annually in accordance with Rule 17f-5(c)(3).

  • Site Visits ‌ The Commission may visit the School at any time and may, at its discretion, conduct site visits and monitoring. When appropriate, the Commission shall make reasonable efforts to provide notice of visits. Such site visits may include any activities reasonably related to fulfillment of the Commission’s oversight responsibilities including, but not limited to, inspection of the facilities; audit of financial books and records; inspection of records maintained by the School; interviews and observations of the principal, staff, school families, staff of an affiliated nonprofit or educational service provider and community members; and observation of classroom instruction.

  • Audit and Collateral Monitoring Fees The Borrowers acknowledge that pursuant to Section 7.01(f), representatives of the Agents may visit any or all of the Loan Parties and/or conduct certain audits, inspections, appraisals, valuations and/or field examinations for which the Borrowers will be obligated to reimburse expenses of the Agents and such representatives. The Borrowers agree to pay such expenses, which shall be calculated on the basis of (i) $1,000 per day per examiner plus the examiner’s reasonable out-of-pocket costs and expenses incurred in connection with all such visits, audits, inspections, appraisals, valuations and field examinations, (ii) a supervisory review fee of $1,300 per each such audit, inspection, valuation or field examination and (iii) the cost of all visits, audits, inspections, appraisals, valuations and field examinations conducted by a third party on behalf of the Agents. Notwithstanding the foregoing, so long as no Event of Default shall have occurred and be continuing, the Borrowers shall not be obligated to pay the fees, costs and expenses for more than three (3) such audits, inspections, valuations and/or field examinations described in clauses (i), (ii) and (iii), in each case conducted during each consecutive twelve (12) month period during the term of this Agreement, provided that Borrowers acknowledge that Administrative may elect to conduct such three (3) audits, inspections, valuations or field examinations with respect to Borrowers during any such consecutive twelve (12) month period at different times, and further provided that, nothing contained in this sentence or otherwise in this Agreement limiting Borrowers’ obligations to pay the fees, costs and expenses of such audits, inspections, valuations or field examinations shall limit the rights of Agents pursuant to the first sentence of this Section 2.06(f) and Section 7.01(f), in each case, if conducted at their own expense. In addition, (x) at any time after the first anniversary of this Agreement, Administrative Agent, acting in its Permitted Discretion, may elect to reduce the number of audits, inspections, valuations and/or field examinations per twelve (12) month period with respect to which Borrowers shall be liable for the fees, costs and expenses thereof (absent the existence of any Event of Default) from three (3) to two (2) if, to the extent and only continuing for so long as such reduction is consistent with Administrative Agent’s governmental regulatory requirements and generally applicable internal policies, and (y) absent the existence of any Event of Default, Agent, acting in its Permitted Discretion, shall use commercially reasonable efforts to endeavor to schedule its periodic audits, inspections, valuations and/or field examinations in a manner to minimize any adverse impact on the operations of Loan Parties to the extent consistent with Administrative Agent’s governmental regulatory requirements and generally applicable internal policies.

  • Measurement and Monitoring Tools Contractor shall implement measurement and monitoring tools and procedures reasonably designed to measure its performance of the Services and assess such performance against any applicable service levels. Contractor shall provide LAUSD with a monthly report of service level performance under any applicable Work Order. Upon LAUSD’s request, Contractor shall provide LAUSD with access to the measurement and monitoring tools described herein, and to any information that they generate.

  • Information Systems Acquisition Development and Maintenance Security of System Files. To protect City Information Processing Systems and system files containing information, Service Provider will ensure that access to source code is restricted to authorized users whose specific job function necessitates such access.

  • Site Visits and Inspections; Regulatory Examinations During the term of this Agreement, authorized representatives of the Fund may conduct periodic site visits of the Transfer Agent’s facilities and inspect the Transfer Agent’s records and procedures solely as they pertain to the Transfer Agent’s services for the Fund under or pursuant to this Agreement. Such inspections shall be conducted at the Fund’s expense (which shall include costs related to providing materials, copying, faxing, retrieving stored materials, and similar expenses) and shall occur during the Transfer Agent’s regular business hours and, except as otherwise agreed to by the parties, no more frequently than twice a year. In connection with such site visit and/or inspection, the Fund shall not attempt to access, nor will it review, the records of any other clients of the Transfer Agent and the Fund shall conduct the visit/inspection in a manner that will not interfere with the Transfer Agent’s normal and customary conduct of its business activities, including the provision of services to the Fund and to other clients. The Transfer Agent shall have the right to immediately require the removal of any Fund representatives from its premises in the event that their actions, in the reasonable opinion of the Transfer Agent, jeopardize the information security of its systems and/or other client data or otherwise are disruptive to the business of the Transfer Agent. The Transfer Agent may require any persons seeking access to its facilities to provide reasonable evidence of their authority. The Transfer Agent may also reasonably require any of the Fund’s representatives to execute a confidentiality agreement before granting such individuals access to its facilities. The Transfer Agent will also provide reasonable access to the Fund’s governmental regulators, at the Fund’s expense, solely to (i) the Fund’s records held by the Transfer Agent and (ii) the procedures of the Transfer Agent directly related to its provision of services to the Fund under the Agreement.

  • ANALYSIS AND MONITORING The Custodian shall (a) provide the Fund (or its duly-authorized investment manager or investment adviser) with an analysis of the custody risks associated with maintaining assets with the Eligible Securities Depositories set forth on Schedule B hereto in accordance with section (a)(1)(i)(A) of Rule 17f-7, and (b) monitor such risks on a continuing basis, and promptly notify the Fund (or its duly-authorized investment manager or investment adviser) of any material change in such risks, in accordance with section (a)(1)(i)(B) of Rule 17f-7.

  • Collateral Monitoring Fee So long as any Advances or Letters of Credit are outstanding during any month or portion thereof, a monthly collateral monitoring fee of $1,500, payable in arrears on the last day of such month (prorated for any partial month), commencing on the last day of the month during which the Effective Date occurs, and upon termination of this Agreement; and

  • Data Acquisition The acquisition of data to realistically simulate the electrical behavior of system components is a fundamental requirement for the development of a reliable interconnected transmission system. Therefore, the TSP and the Generator shall be required to submit specific information regarding the electrical characteristics of their respective facilities to each other as described below in accordance with ERCOT Requirements.

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