Reporting to Competent Authorities/ Independent Ethics Committees/ Institutional Review Boards/ Other Investigators Sample Clauses

Reporting to Competent Authorities/ Independent Ethics Committees/ Institutional Review Boards/ Other Investigators. The sponsor or spousor's representative will ensure that processes are in place for submission of reports of Suspected Unexpected Serious Adverse Reactions occurring during the study to the CAs, Independent Ethics Committees (IECs) and other investigators concerned by the IMP. Reporting will be done in accordance with the applicable regulatory requirements. For study sites in the USA, Investigational New Drug application Safety Reports will be submitted directly to the iuvestigators. It is the iuvestigators' respousibility to uotify their Institutional Review Board (IRB) in a timely manner.
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Reporting to Competent Authorities/ Independent Ethics Committees/ Institutional Review Boards/ Other Investigators. The sponsor or sponsor’s representative will ensure that processes are in place for submission of reports of Suspected Unexpected Serious Adverse Reactions occurring during the study to the CAs, Independent Ethics Committees (IECs) and other investigators concerned by the IMP. Reporting will be done in accordance with the applicable regulatory requirements. For study sites in the USA, Investigational New Drug application Safety Reports will be submitted directly to the investigators. It is the investigators’ responsibility to notify their Institutional Review Board (IRB) in a timely manner.

Related to Reporting to Competent Authorities/ Independent Ethics Committees/ Institutional Review Boards/ Other Investigators

  • 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.

  • Nurse Representatives & Grievance Committee (a) The Hospital agrees to recognize Association representatives to be elected or appointed from amongst nurses in the bargaining unit for the purpose of dealing with Association business as provided in this Collective Agreement. The number of representatives and the areas which they represent are set out in the Appendix of Local Provisions.

  • Union Grievance Committee (a) The Employer shall recognize a Union Grievance Committee which consists of:

  • 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.

  • 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 Objections to Grievances It is the intent of both Parties of this Agreement that no grievance shall be defeated merely because of a technical error, other than time limitations in processing the grievance through the grievance procedure. To this end, an arbitration board shall have the power to allow all necessary amendments to the grievance and the power to waive formal procedural irregularities in the processing of a grievance, in order to determine the real matter in dispute and to render a decision according to equitable principles and the justice of the case.

  • Local Safety Committee There shall be established in each department and/or principal place of employment (for example: institutions, hospitals, colleges, transportation department areas, Department of Natural Resources regions, etc.) a joint Safety Committee composed of Appointing Authority representatives selected by the Appointing Authority and employee representatives selected by the Union, one from each bargaining unit represented by the Union but at a minimum, a total of two (2) representatives. If more than one (1) exclusive representative exists in the department or principal place of employment, the Union will attempt to work out an arrangement with the other exclusive bargaining representative(s) to insure their input to the Committee. The chair of the Committee shall be appointed by the Appointing Authority. The Appointing Authority may consider having co-chairs, one management and one labor. The Safety Committee shall meet at least quarterly or as may be legally required and meetings shall be scheduled by the Safety Officer. Additional meetings may be called by the Safety Officer or by the Local Union or Appointing Authority as the need may arise. All Safety Committee meetings shall be held during normal day shift working hours on the Appointing Authority's premises and without loss of pay. The function of the Safety Committee will be to review reports of property damage and personal injury accidents and alleged hazardous working conditions, to provide support for a strong safety program, to review building security issues, and to review and recommend safety policies to the Appointing Authority. Normally, the Committee shall acknowledge in writing receipt of reports of alleged hazardous working conditions within thirty (30) calendar days of their submission. A copy of the Committee's recommendations, if any, to the Appointing Authority regarding the disposition of such reports shall also be provided to the individual who filed the report with the Committee. In addition, the Safety Committee will provide the filing party with a copy of the Appointing Authority's response and/or proposed actions, if any. At the request of the Local Union or Safety Committee, hazard assessments will be made available for review. Each Local Safety Committee in a facility with a laundry and/or a kitchen shall perform a routine heat survey to check temperature, humidity, and exhaust and fan systems in the laundries and kitchens. The Employer agrees to coordinate technical assistance to the Local Safety Committee upon request.

  • 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.

  • Departmental Review If informal resolution of the problem through conciliation and negotiation cannot be effected, an aggrieved person may file a formal complaint with the departmental affirmative action coordinator or other designated official. Such a complaint must be filed on a form provided for this purpose and within five working days after the attempted resolution of the problem by the equal employment opportunity counselor or within twenty-five (25) working days after the date of the alleged discriminatory action, whichever shall first occur. The affirmative action coordinator will decide whether the complaint falls within the jurisdiction of the procedure and accept or reject it. Upon acceptance of the complaint, the affirmative action coordinator shall obtain the notes on the case from the equal employment opportunity counselor; may conduct a prompt, impartial investigation if he deems it necessary; shall explore the possibility of resolving the problem through negotiation or conciliation; shall present findings and recommendations on resolving the complaint to the agency/department head; and within forty-five (45) working days from the date the formal complaint was filed, shall present his written decision, as approved by the agency/department head, to the complainant, with a copy of the complaint and decision to be forwarded to the director of personnel.

  • Joint Safety Committee (a) The Union and the Company shall cooperate in selecting one or more Safety Committees, which will meet at least once a month to consider all safety and occupational health problems.

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