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.
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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. • 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. • 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. • 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
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. 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
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Related to Interim Monitoring Visits

  • Contract Monitoring The criminal background checks required by this rule shall be national in scope, and must be conducted at least once every three (3) years. Contractor shall make the criminal background checks required by Paragraph IV.G.1 available for inspection and copying by DRS personnel upon request of DRS.

  • Program Monitoring The Contractor will make all records and documents required under this Agreement as outlined here, in OEC Policies and NHECC Policies available to the SRO or its designee, the SR Fiscal Officer or their designee and the OEC. Scheduled monitoring visits will take place twice a year. The SRO and OEC reserve the right to make unannounced visits.

  • Project Monitoring The Developer shall provide regular status reports to the NYISO in accordance with the monitoring requirements set forth in the Development Schedule, the Public Policy Transmission Planning Process Manual and Attachment Y of the OATT.

  • Monitoring Services IDT staff shall, using methods that include face-to-face and other contacts with the member, monitor the services a member receives. This monitoring shall ensure that: a. The member receives the services and supports authorized, arranged for and coordinated by the IDT staff; b. The services and supports identified in the MCP as being provided by natural and community supports are being provided; and c. The quality of the services and supports received is adequate and still necessary to continue to meet the needs and preferences of the member and support the member’s outcomes identified in the MCP.

  • Compliance Monitoring Grantee must be subject to compliance monitoring during the period of performance in which funds are Expended and up to three years following the closeout of all funds. In order to assure that the program can be adequately monitored, the following is required of Grantee: a. Grantee must maintain a financial tracking system provided by Florida Housing that ensures that CRF funds are Expended in accordance with the requirements in this Agreement. b. Grantee must maintain records on all awards to Eligible Persons or Households. These records must include, but are not limited to: i. Proof of income compliance (documentation from submission month, including but not limited to paystub, Florida unemployment statement, social security and/or disability statement, etc.); ii. Lease; and iii. Documentation of rental assistance payments made.

  • Project Monitoring Reporting and Evaluation The Recipient shall furnish to the Association each Project Report not later than forty-five (45) days after the end of each calendar semester, covering the calendar semester.

  • 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.

  • Program Monitoring and Evaluation The Recipient shall prepare, or cause to be prepared, and furnish to the Association not later than six months after the Closing Date, a report of such scope and in such detail as the Association shall reasonably request, on the execution of the Program, the performance by the Recipient and the Association of their respective obligations under the Legal Agreements and the accomplishment of the purposes of the Financing.”

  • Monitoring Arrangements 8.1 We will formally monitor the progress of the access agreement at least once a year and report annually to the SCITT Management Group. Initial monitoring will be concerned with participation rates and the development of data on lower income and other under-represented groups. When specific data is accrued, we will look to monitor against this. 8.2 Our annual report to the SCITT Management Group will form the basis of our monitoring report to OFFA.

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