Study Initiation Visits Sample Clauses

Study Initiation Visits. ‌ The study monitor or designee will communicate with study site and identify a date, time and location to meet with the clinical investigator(s), coordinator, and other key personnel involved in the study. A memo will be distributed to all key personnel confirming the date, time, location and purpose of the visit along with a detailed agenda. Prior to the study initiation site visit, the clinical site should submit the following documents to the study monitor, or have them available for collection during the visit: • Signed Investigator Agreement, • Curriculum vitae of investigator, • Medical license of investigator, • Signed Financial Disclosure Form, and • REB/Ethics committee approval documentation of protocol and informed consent form. The study monitor will review the study protocol requirements with special emphasis on the inclusion and exclusion criteria, study objectives, safety and efficacy endpoints, AE reporting, participant withdrawal criteria, the visit schedule and required assessments, special clinical procedures, study stopping rules, and other key site requirements for study support. The study monitor will review the site’s procedures for obtaining and documenting the participant’s informed consent, including who is responsible for this process and the location of the completed forms. A thorough review of the regulatory binder with site staff and investigator will be performed for completeness. The study monitor will review the protocol case report forms and the site’s plans for maintaining adequate source documentation.
Sample 1
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Related to Study Initiation Visits

  • Study An application for leave of absence for professional study must be supported by a written statement indicating what study or research is to be undertaken, or, if applicable, what subjects are to be studied and at what institutions.

  • Clinical Trials The studies, tests and preclinical and clinical trials conducted by or on behalf of, or sponsored by, the Company, or in which the Company has participated, that are described in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, were and, if still pending, are being conducted in all material respects in accordance with protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company and all applicable statutes, rules and regulations of the FDA, the EMEA, Health Canada and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States to which they are subject; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleading; the Company has no knowledge of any studies, tests or trials not described in the Disclosure Package and the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Registration Statement, the Time of Sale Disclosure Package or Prospectus; and the Company has not received any notices or other correspondence from the FDA, EMEA, Health Canada or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus, there has not been any violation of law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action.

  • Development Phase contractual phase initiated with the approval of ANP for the Development Plan and which is extended during the Production Phase while investments in xxxxx, equipment, and facilities for the Production of Oil and Gas according to the Best Practices of the Oil Industry are required.

  • Clinical 2.1 Provides comprehensive evidence based nursing care to patients including assessment, intervention and evaluation.

  • Trials The Ship shall run the following test and trials:

  • Phase 2 Phase 2 is expected to consist of Member Nodes and a select number of Nodes operated by non-Members. The non-Member Nodes will be required to comply with Node hosting terms as set forth by the Council, which may be amended from time to time (the “General Node Terms”).

  • Development Activities The Development activities referred to in item “b” of paragraph 3.1 include: studies and projects of implementation of the Production facilities; drilling and completion of the Producing and injection xxxxx; and installation of equipment and vessels for extraction, collection, Treatment, storage, and transfer of Oil and Gas. The installation referred to in item “c” includes, but is not limited to, offshore platforms, pipelines, Oil and Gas Treatment plants, equipment and facilities for measurement of the inspected Production, wellhead equipment, production pipes, flow lines, tanks, and other facilities exclusively intended for extraction, as well as oil and gas pipelines for Production Outflow and their respective compressor and pumping stations.

  • System Impact Study An assessment by the Transmission Provider of (i) the adequacy of the Transmission System to accommodate a Completed Application, an Interconnection Request or an Upgrade Request, (ii) whether any additional costs may be incurred in order to provide such transmission service or to accommodate an Interconnection Request, and (iii) with respect to an Interconnection Request, an estimated date that an Interconnection Customer’s Customer Facility can be interconnected with the Transmission System and an estimate of the Interconnection Customer’s cost responsibility for the interconnection; and (iv) with respect to an Upgrade Request, the estimated cost of the requested system upgrades or expansion, or of the cost of the system upgrades or expansion, necessary to provide the requested incremental rights.

  • Study Area The study area focused on the Bulk Power System in South-Eastern New York between Albany and New York City, and voltages underlying systems at 115 kV and above in the lower Xxxxxx Valley (Zones G, H & I). In the PSS™E power flow base case provided by NYISO, facilities rated at 115 kV and above in PSS™E designated areas 6 through 11 are monitored in the study. These areas are: • Capital District • Xxxxxx • Millwood • Xxxxxxxxx • Con Ed • Long Island

  • The Study 2.1The parties must comply with, and conduct the Study in accordance with, the Protocol and any conditions of the Reviewing HREC. In addition the parties must comply with the following, as applicable:

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