INVESTIGATIONAL PLAN Sample Clauses

INVESTIGATIONAL PLAN. 3.1 Overall Design and Study Plan Figure 2: Protocol BA058-05-005 Study Design
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INVESTIGATIONAL PLAN. 7.1. Overall Study Design
INVESTIGATIONAL PLAN. 3.1 Overall Design and Study Plan This study is an open-label extension of Study BA058-05-003. Subjects and Investigators who participate in Study BA058-05-005 will remain blinded to prior treatment assignment as part of BA058-05-003. At the End-of-Treatment visit (Visit 9) for Study BA058-05-003, the possibility of participating in the Extension Study will be discussed with subjects randomized to BA058 80 µg/Placebo. The Extension Study will be comprised of an initial six months of treatment with alendronate. In the month between Visit 9 and Visit 10, the Investigator will review the results of the assessments performed at Visit 9, including a local interpretation of BMD, and determine if alendronate is appropriate for the subject. All subjects will continue to receive vitamin D and calcium supplementation as they did in Study BA058-05-003. The study design is presented in Figure 2, below. Participation for both the initial and observational phases of the will be approximately 24 months. There are a total of six clinic visits during the course of the study. A brief summary of the study is provided below. For a summary of the study assessments to be performed, refer to Section 7.0 (Study Assessments) and to the Schedule of Visits and Procedures (Appendix 14.1). A more detailed description of the study procedures on a by-visit basis is provided in Appendix 14.2 (Suggested Schedule of Events and Procedures by Study Visit). A suggested order of procedures is also provided in this schedule.
INVESTIGATIONAL PLAN 

Related to INVESTIGATIONAL PLAN

  • Investigational Services This plan covers certain experimental or investigational services as described in this section. This plan covers clinical trials as required under R.I. General Law § 27-20-60. An approved clinical trial is a phase I, phase II, phase III, or phase IV clinical trial that is being performed to prevent, detect or treat cancer or a life-threatening disease or condition. In order to qualify, the clinical trial must be: • federally funded; • conducted under an investigational new drug application reviewed by the Food and Drug Administration (FDA); or • a drug trial that is exempt from having such an investigational new drug application. To qualify to participate in a clinical trial: • you must be determined to be eligible, according to the trial protocol; • a network provider must have concluded that your participation would be appropriate; and • medical and scientific information must have been provided establishing that your participation in the clinical trial would be appropriate. If a network provider is participating in a clinical trial, and the trial is being conducted in the state in which you reside, you may be required to participate in the trial through the network provider. Coverage under this plan includes routine patient costs for covered healthcare services furnished in connection with participation in a clinical trial. The amount you pay is based on the type of service you receive. Coverage for clinical trials does not include: • the investigational item, device, or service itself; • items or services provided solely to satisfy data collection and that are not used in the direct clinical management; or • a service that is clearly inconsistent with widely accepted standards of care.

  • Investigation and Prevention DST shall reasonably assist Fund in investigating of any such unauthorized access and shall use commercially reasonable efforts to: (A) cooperate with Fund in its efforts to comply with statutory notice or other legal obligations applicable to Fund or its clients arising out of unauthorized access and to seek injunctive or other equitable relief; (B) cooperate with Fund in litigation and investigations against third parties reasonably necessary to protect its proprietary rights; and (C) take reasonable actions necessary to mitigate loss from any such authorized access.

  • Complaints Investigation The employee who complains of harassment under the provisions of the Human Rights Code must first comply with the Employer’s harassment policy procedures before filing a grievance or human rights complaint.

  • Background Investigation The BOARD is prohibited from knowingly employing a person who has been convicted of committing or attempting to commit certain criminal offenses. If the required criminal background investigation is not completed at the time this Contract is signed, and the subsequent investigation report reveals that there has been a prohibited conviction, this Contract shall immediately become null and void.

  • Grievance Investigation The Employer agrees to supply to the Union the names of all applicants for a vacancy, or new position in the course of a grievance investigation.

  • Geotechnical Investigation Perform in accordance with the City Design Manual and other City requirements as designated in writing by the Director.

  • Investigation Period The first sentence of Section 4.1 of the Purchase Agreement is hereby deleted in its entirety and the following is hereby substituted in lieu thereof: “During the time period commencing upon the Effective Date of this Agreement, and terminating at 11:59 p.m. on October 18, 2012 (the “Investigation Period”), Buyer shall have the right to conduct and complete an investigation of all matters pertaining to the Property and Buyer’s purchase thereof including, without limitation, the matters described in this Section 4.1.”

  • Investigations; Litigation There is no investigation or review pending (or, to the knowledge of Parent, threatened) by any Governmental Entity with respect to Parent or any of its Subsidiaries which would have, individually or in the aggregate, a Parent Material Adverse Effect, and there are no actions, suits, inquiries, investigations or proceedings pending (or, to Parent’s knowledge, threatened) against or affecting Parent or its Subsidiaries, or any of their respective properties at law or in equity before, and there are no orders, judgments or decrees of, or before, any Governmental Entity, in each case which would have, individually or in the aggregate, a Parent Material Adverse Effect.

  • Environmental Investigation (a) Heritage shall engage an environmental consultant acceptable to Acquiror to conduct a preliminary ("Phase I") environmental assessment of each of the parcels of real estate used in the operation of the businesses of Heritage and any Heritage Subsidiary and any other real estate owned by Heritage or a Heritage Subsidiary (other than single family residences). The fees and expenses of the consultant with respect to the Phase I assessments shall be shared equally by Acquiror and Heritage. The consultant shall complete and deliver the Phase I assessments not later than 60 days after the date of this Agreement. If any environmental conditions are found, suspected, or would tend to be indicated by the report of the consultant which may be contrary to the representations and warranties of Heritage set forth herein without regard to any exceptions that may be contained in Heritage's Schedules, then the parties shall obtain from one or more mutually acceptable consultants or contractors, as appropriate, an estimate of the cost of any further environmental investigation, sampling, analysis, remediation or other follow-up work that may be necessary to address those conditions in accordance with applicable laws and regulations. (b) Upon receipt of the estimate of the costs of all follow-up work to the Phase I assessments or any subsequent investigation phases that may be conducted, the parties shall attempt to agree upon a course of action for further investigation and remediation of any environmental condition suspected, found to exist, or that would tend to be indicated by the report of the consultant. All post-Phase I investigations or assessments (the cost of which shall be paid by Heritage), all work plans for any post-Phase I assessments or remediation, and any removal or remediation actions that may be performed, shall be mutually satisfactory to Acquiror and Heritage. If such work plans or removal or remediation actions would cost more than $3,000,000 (individually or in the aggregate on a tax affected basis) to complete, Acquiror and Heritage shall discuss a mutually acceptable modification of this Agreement. Acquiror and Heritage shall cooperate in the review, approval and implementation of all work plans. (c) If the parties are unable to agree upon a course of action for further investigation and remediation of an environmental condition or issue raised by an environmental assessment and/or a mutually acceptable modification to this Agreement, and the condition or issue is not one for which it can be determined to a reasonable degree of certainty that the risk and expense to which the Surviving Corporation and its Subsidiaries would be subject as owner of the property involved can be quantified, in good faith, and limited to an amount less than $3,000,000 (on a tax affected basis), then Acquiror may terminate this Agreement by the earlier to occur of (i) 120 days after the receipt of the Phase I assessments, or (ii) the receipt of all consents and approvals of government regulatory authorities as legally required to consummate the Merger and the expiration of all statutory waiting periods.

  • Investigation of Accidents The Occupational Health and Safety Committees, as provided in Clause 22.2, shall be notified of each accident or injury and shall investigate and report to the Union and Employer on the nature and cause of the accident or injury. In the event of a fatality the Employer shall immediately notify the President of the nature and circumstances of the accident.

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