Responsibilities of the Independent Safety Monitoring Board Sample Clauses

Responsibilities of the Independent Safety Monitoring Board. An Independent Safety Monitoring Board (ISMB) will be established prior to the start of the study to monitor the safety of BL-1040 during the conduct of the protocol. This ISMB will consist of physicians with expertise in cardiovascular disease, particularly in the area of coronary artery disease and with experience monitoring safety of drugs and/or devices for cardiovascular applications, and will have no participation in the trial in any other capacity. The ISMB will ensure that this study meets the highest standards of patient safety. During the study the ISMB will have the following main responsibilities: · review 30 day safety data patients from the first 2 sequentially enrolled patients to determine whether 3 additional patients may be enrolled: after reviewing the 30 day safety data from these 3 patients, will determine whether the balance of patients may be enrolled · within 30 days of enrolment of each successive group of 5 patients receiving the device, will review all SAEs occurring to date and will recommend continuation, discontinuation, or modification of the procedure or protocol, based on a determination of whether the occurrence of serious, unexpected, or device-related adverse events (Sec. 7) might outweigh the potential benefit achievable with the device · review emerging findings in patients and identify potential safety concerns with BL-1040 · will receive information, on an expedited basis, on all Serious Adverse Events (SAEs), clinically significant laboratory values/xxxxx xxxxx, ECG abnormalities and data from patients who decided to prematurely discontinue the study. All SAES that occur in the cath lab during or after the procedure to administer BL-1040 should be reviewed promptly by the ISMB. The ISMB will review this information and may decide to interrupt, alter, or terminate the trial · will adjudicate whether or not an event is unexpected, based on a pre-specified list of expected SAEs within the study population.
Sample 1Sample 2Sample 3See All (7)
AutoNDA by SimpleDocs

Related to Responsibilities of the Independent Safety Monitoring Board

  • Responsibilities of the Contractor The Contractor shall provide all technical and professional expertise, knowledge, management, and other resources required for accomplishing all aspects of the tasks and associated activities identified in the Scope of Work. In the event that the need arises for the Contractor to perform services beyond those stated in the Scope of Work, the Contractor and the City shall negotiate mutually agreeable terms and compensation for completing the additional services.

  • RESPONSIBILITIES OF THE UNIVERSITY The UNIVERSITY shall designate in writing a faculty member to coordinate with a designee of the FIELDWORK SITE.

  • Responsibilities of Contractor A. The Contractor shall perform all work on the described project as required by the Contract documents. The work to be performed includes the labor and services necessary to produce such replacement, and all materials, supplies, tools, transportation, equipment, and machinery required for replacement. B. This project bid includes all materials, labor and equipment to complete the reconstruction and resurfacing of streets as outlined in the Project Manual for WWREYN - XXXXXXXX SANITARY SEWER - PHASE 1 dated March 25th, 2021 as outlined in Attachment A.

  • Responsibilities of the Company 3.3.1 The Company shall provide participants of CopyTrade with a complete package of services according to the Customer Agreement. The Company is liable for proper performance of technological solutions according to the Customer Agreement. 3.3.2 The Company bears no liability to participants of CopyTrade for lost profit or losses, which may directly or indirectly occur as a result of trading operations performed or not performed by an Investor or a Trader. 3.3.3 The Company bears no liability to participants of CopyTrade for lost profit or losses, which may be directly or indirectly occur as a result of their ignorance of regulatory documents or cooperation scheme. 3.3.4 The Company doesn’t evaluate Traders’ professional skills and suitability not on a single stage of their activity and bears no responsibility to Investors for any losses or lost profit they may incur. 3.3.5 The Company is not liable for:

  • RESPONSIBILITIES OF THE OWNER The Owner agrees to: Provide all documentation, records, and disclosures as required by law or required by the Agent to manage and operate the Property, and immediately notify the Agent if the Owner becomes aware of any change in such documentation, records or disclosures, or any matter affecting the habitability of the Property; Indemnify, defend, and hold harmless the Agent, and all persons in the Agent's firm, regardless of responsibility, from all costs, expenses suits, liabilities, damages, attorneys fees, and claims of every type, including, but not limited to, those arising out of injury or death of any person, or damage to any real or personal property of any person, including the Owner, for: Any repairs performed by the Owner or by others hired directly by the Owner; or Those relating to the management, leasing, rental, security deposit, or operation of the Property by the Agent, or any person in the Agent's company, or the performance or exercise of any of the duties, powers, or authorities granted to the Agent; This sub-section, and all rights to the Agent’s indemnification, shall be considered void if the Agent exemplifies any willful acts of gross negligence; Maintain the Property in a condition fit for human habitation as required by applicable State and local laws; Pay all interest on Tenants’ security deposits if required by applicable laws; Carry and pay for: Public and premises liability insurance in an amount of no less than one-million dollars ($1,000,000.00); and Property damage and worker’s compensation insurance adequate to protect the interests of the Owner and the Agent. The Agent shall be, and the Owner authorizes Agent to be, named as an additional insured party on the Owner’s policies; and Pay any late charges, penalties and/or interest imposed by lenders or other parties for failure to make payment only if the failure is due to insufficient funds in the Agent’s trust account available for such payment. In addition, the Owner agrees to replace any funds required if there are insufficient funds in the Agent’s trust account to cover such responsibilities of the Owner.

  • Responsibilities of Adviser In carrying out its obligations under this Agreement, the Adviser agrees that it will: (a) Comply with all applicable law, including but not limited to the 1940 Act and the Advisers Act, the rules and regulations of the Commission thereunder, and the conditions of any order affecting the Trust or a Fund issued thereunder; (b) Use the same skill and care in providing such services as it uses in providing services to other fiduciary accounts for which it has investment responsibilities; (c) Not make loans to any person for the purpose of purchasing or carrying Fund shares; (d) Place, or arrange for the placement of, all orders pursuant to its investment determinations for the Funds either directly with the issuer or with any broker or dealer (including any affiliated broker or dealer). In executing portfolio transactions and selecting brokers or dealers, the Adviser will use its best efforts to seek on behalf of each Fund the best overall terms available. In assessing the best overall terms available for any transaction, the Adviser shall consider all factors that it deems relevant, including the breadth of the market in the security, the price of the security, the financial condition and execution capability of the broker or dealer, and the reasonableness of the commission, if any, both for the specific transaction and on a continuing basis. In evaluating the best overall terms available, and in selecting the broker or dealer to execute a particular transaction, the Adviser may also consider whether such broker or dealer furnishes research and other information or services to the Adviser; (e) Adhere to the investment objective, strategies and policies and procedures of the Trust adopted on behalf of each Fund; and (f) Maintain a policy and practice of conducting its investment advisory services hereunder independently of the commercial banking operations of its affiliates. In making investment recommendations for a Fund, the Adviser's investment advisory personnel will not inquire or take into consideration whether the issuers (or related supporting institutions) of securities proposed for purchase or sale for the Fund's account are customers of the commercial departments of its affiliates. In dealing with commercial customers, such commercial departments will not inquire or take into consideration whether securities of those customers are held by the Fund.

  • Responsibilities of the District 12.1. The District shall examine the documents submitted by the Architect and shall render decisions so as to avoid unreasonable delay in the process of the Architect’s Services. 12.2. The District shall verbally or in writing advise Architect if the District becomes aware of any fault or defect in the Project, including any errors, omissions or inconsistencies in the Architect’s documents. Failure to provide such notice shall not relieve Architect of its responsibility therefore, if any. 12.3. Unless the District and Architect agree that a hazardous materials consultant shall be a Consultant of the Architect, the District shall furnish the services of a hazardous material consultant or other consultants when such services are requested in writing by Architect and deemed necessary by the District or are requested by the District. These services shall include: asbestos and lead paint survey; abatement documentation; and specifications related to said matters, which are to be incorporated into bid documents prepared by Architect. If the hazardous materials consultant is furnished by the District and is not a Consultant of the Architect, the specifications shall include a note to the effect that the hazardous materials consultant’s specifications are included in the Architect’s bid documents for the District’s convenience and have not been prepared or reviewed by the Architect. The note shall also direct questions about the hazardous materials consultant’s specifications related to asbestos and lead paint survey and/or abatement documentation to the preparer of the hazardous materials consultant’s specifications.

  • Responsibilities of Consultant a. Consultant, as an independent contractor to Client, shall perform the Scope of Work (Exhibit A) in accordance with, and subject to, the other provisions of this Agreement. b. The Scope of Work shall be performed in accordance with all applicable federal, state, and local rules and regulations including, but not limited to, the requirements of the Storage Tank and Spill Prevention Act (Act 32 of 1989, as amended) and Pa. Code, Title 25, Chapter 245, established under the Land Recycling and Environmental Remediation Standards Act (Act 2 of 1995) and Pa. Code, Chapter 250 (Administration of Land Recycling Program). c. Consultant shall perform the Scope of Work for an amount not to exceed the Base Contract Price (“BCP”) of $[insert BCP] plus any Cost Adders, Optional Milestones and/or Unit Costs, subject to all other provisions of this Agreement. d. Consultant shall participate in periodic site meetings with the Client and PAUSTIF for site status updates. Consultant will be provided no less than ten (10) days written notice of the date, time, and location of the meeting by the Client/PAUSTIF through their third party administrator.

  • Responsibilities of the City The City’s Contract Manager will be responsible for exercising general oversight of the Contractor’s activities in completing the Scope of Work. Specifically, the Contract Manager will represent the City’s interests in resolving day-to-day issues that may arise during the term of this Contract, shall participate regularly in conference calls or meetings for status reporting, shall promptly review any written reports submitted by the Contractor, and shall approve all invoices for payment, as appropriate. The City’s Contract Manager shall give the Contractor timely feedback on the acceptability of progress and task reports.

  • Responsibilities of Both Parties 6.1 The CLEC providing the circuit between CLEC’s office and SBC-12STATE’s office shall make such circuits available for use in connection with the DA services covered herein. When the total traffic exceeds the capability of the existing circuits, additional circuits will be provided by the CLEC. 6.2 Where applicable, if additional ADAX cards and ASN Routers (with sync and token ring cards) are necessary, they will be provided by SBC-12STATE, and CLEC will reimburse SBC-12STATE for the cost, plus Engineering, Furnish and Installation.

Draft better contracts in just 5 minutes Get the weekly Law Insider newsletter packed with expert videos, webinars, ebooks, and more!