Institutional Review Boards and Independent Ethics Committees Sample Clauses

Institutional Review Boards and Independent Ethics Committees. ‌ The protocol and consent form will be reviewed and approved by the IRB/IEC of each participating center prior to study initiation. SAEs regardless of causality will be reported to the IRB/IEC in accordance with the standard operating procedures and policies of the IRB/IEC, and the Investigator will keep the IRB/IEC informed as to the progress of the study. The Investigator will obtain assurance of IRB/IEC compliance with regulations. Any documents that the IRB/IEC may need to fulfill its responsibilities (such as protocol, protocol amendments, Investigator’s Brochure, consent forms, information concerning patient recruitment, payment or compensation procedures, or other pertinent information) will be submitted to the IRB/IEC. The IRB/IECs written unconditional approval of the study protocol and the informed consent form will be in the possession of the Investigator before the study is initiated. The IRB/IEC’s unconditional approval statement will be transmitted by the Investigator to the Sponsor or designee prior to the shipment of study supplies to the site. This approval must refer to the study by exact protocol title and number and should identify the documents reviewed and the date of review. Protocol and/or informed consent modifications or changes may not be initiated without prior written IRB/IEC approval except when necessary to eliminate immediate hazards to the patients or when the change(s) involves only logistical or administrative aspects of the study. Such modifications will be submitted to the IRB/IEC and written verification that the modification was submitted and subsequently approved should be obtained. The IRB/IEC must be informed of revisions to other documents originally submitted for review; serious and/or unexpected adverse experiences occurring during the study in accordance with the standard operating procedures and policies of the IRB; new information that may affect adversely the safety of the patients of the conduct of the study; an annual update and/or request for re-approval; and when the study has been completed.
Sample 1
AutoNDA by SimpleDocs

Related to Institutional Review Boards and Independent Ethics Committees

  • LABOR/MANAGEMENT COMMITTEES Section 1. Labor/Management Committees The parties recognize that the holding of periodic meetings for the exchange of views and information contributes to the effectiveness of the labor/management relationship. Therefore, the parties shall establish Labor/Management Committees (LMC), in accordance with the provisions in this Article, for the purpose of addressing matters of concern in the areas of personnel policies, practices, conditions of employment, and other matters affecting employees. Each LMC will be co-chaired by one member from labor and one member from management.

  • Office of Inspector General Investigative Findings Expert Review In accordance with Senate Bill 799, Acts 2021, 87th Leg., R.S., if Texas Government Code, Section 531.102(m-1)(2) is applicable to this Contract, Contractor affirms that it possesses the necessary occupational licenses and experience.

  • Joint Labor/Management Committees Purpose and Membership. Joint Labor/Management Committees are established to provide a forum for communications and problem-solving between the two parties and to deal with matters of a general personnel Union/Employer concern, as well as professional practices within the hospital related to patient care and professional issues. The Committees will work toward the improvement of patient care and recommend ways and means to improve patient care; and will address problems and concerns related to staffing and workloads. The Committees’ function will be limited to an advisory capacity and shall not include any decision making or collective bargaining authority. Committee memberships:

  • Training Committee The parties to this Agreement may form a Training Committee. The Training Committee will be constituted by equal numbers of Employer nominees and ETU employee representatives and have a charter which clearly states its role and responsibilities. It shall monitor the clauses of this Agreement which relate to training and ensure all employees have equal access to training.

  • Recognition of Union Stewards and Grievance Committee In order to provide an orderly and speedy procedure for the settling of grievances, the Employer acknowledges the rights and duties of the Union Stewards. The Xxxxxxx shall assist any Employee, which the Xxxxxxx represents, in preparing and presenting her grievance in accordance with the grievance procedure.

  • SCHOOL STAFF COMMITTEES 1. If the majority of the teaching staff in the school so decide, there shall be established a recognized staff committee in that school.

  • Technical Advisory Committee (TAC The goal of this subtask is to create an advisory committee for this Agreement. The TAC should be composed of diverse professionals. The composition will vary depending on interest, availability, and need. TAC members will serve at the CAM’s discretion. The purpose of the TAC is to: • Provide guidance in project direction. The guidance may include scope and methodologies, timing, and coordination with other projects. The guidance may be based on: o Technical area expertise; o Knowledge of market applications; or o Linkages between the agreement work and other past, present, or future projects (both public and private sectors) that TAC members are aware of in a particular area. • Review products and provide recommendations for needed product adjustments, refinements, or enhancements. • Evaluate the tangible benefits of the project to the state of California, and provide recommendations as needed to enhance the benefits. • Provide recommendations regarding information dissemination, market pathways, or commercialization strategies relevant to the project products. The TAC may be composed of qualified professionals spanning the following types of disciplines: • Researchers knowledgeable about the project subject matter; • Members of trades that will apply the results of the project (e.g., designers, engineers, architects, contractors, and trade representatives); • Public interest market transformation implementers; • Product developers relevant to the project; • U.S. Department of Energy research managers, or experts from other federal or state agencies relevant to the project; • Public interest environmental groups; • Utility representatives; • Air district staff; and • Members of relevant technical society committees. The Recipient shall: • Prepare a List of Potential TAC Members that includes the names, companies, physical and electronic addresses, and phone numbers of potential members. The list will be discussed at the Kick-off meeting, and a schedule for recruiting members and holding the first TAC meeting will be developed. • Recruit TAC members. Ensure that each individual understands member obligations and the TAC meeting schedule developed in subtask 1.11. • Prepare a List of TAC Members once all TAC members have committed to serving on the TAC. • Submit Documentation of TAC Member Commitment (such as Letters of Acceptance) from each TAC member. Products: • List of Potential TAC Members • List of TAC Members • Documentation of TAC Member Commitment

  • Technical Committee 1. The Technical Committee shall comprise:

  • Evaluation Committee A The Association and the Board agree to establish a standing joint Evaluation Development Committee for the purpose of establishing the procedure and process, including the evaluation instrument, for the evaluation of teachers in the District and to regularly review the effectiveness of the procedure and process, including the evaluation instrument, for the evaluation of teachers in the District.

  • LABOR MANAGEMENT COMMITTEE 1. A Statewide Labor Management Committee consisting of not more than five (5) members selected by the VSEA from among bargaining units represented by VSEA and not more than five (5) members selected by the State shall meet periodically to discuss a mutually agreed agenda which may include methods of improving labor relations, productivity, safety, and health problems of a continuing nature, or other problems which have an impact on conditions of employment; provided, however, these sessions are not for the purpose of discussing pending grievances or for collective bargaining on any subject.

Time is Money Join Law Insider Premium to draft better contracts faster.