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. (b) The Hospital will recognize a Grievance Committee, one of whom shall be chair. This committee shall operate and conduct itself in accordance with the provisions of the Collective Agreement and the number of nurses on the Grievance Committee is set out in the Appendix of Local Provisions. (c) It is agreed that Union representatives and members of the Grievance Committee have their regular duties and responsibilities to perform for the Hospital and shall not leave their regular duties without first obtaining permission from their immediate supervisor. Such permission shall not be unreasonably withheld. If, in the performance of their duties, a union representative or member of the Grievance Committee is required to enter a unit within the hospital in which they are not ordinarily employed they shall, immediately upon entering such unit, report their presence to the supervisor or nurse in charge, as the case may be. When resuming their regular duties and responsibilities, such representatives shall again report to their immediate supervisor. The Hospital agrees to pay for all time spent during their regular hours by such representatives hereunder.

  • Joint Remediation Committee If the Sellers (acting reasonably) determine that the Purchasers have committed a Major Default, then, at the election of the Sellers, within three (3) Business Days of the Sellers providing the Purchasers written notice of such determination, the Sellers and the Purchasers shall establish a joint remediation committee of designated executives from the Sellers and the Purchasers (“Joint Remediation Committee”) consisting of three (3) members of each of the Sellers and the Purchasers. The Joint Remediation Committee shall be responsible for overseeing the development of a mutually agreeable plan in accordance with subsection 3 below to either (i) remediate any breaches giving rise to the Major Default to the extent such breaches can be remediated and/or (ii) prevent similar breaches from recurring in the future (clauses (i) and (ii), a “Corrective Action Plan”). Each member of the Joint Remediation Committee shall have sufficient authority on the part of his or her respective party to make decisions relating to matters reviewed by the Joint Remediation Committee, and shall be approved by the other party (such approval not to be unreasonably delayed, conditioned or withheld). The Joint Remediation Committee shall have access to Purchaser Personnel that are primarily responsible for the area of the business relationship (such as information technology, data security or regulatory) where the breaches giving rise to the Major Default arise (such Purchaser Personnel, collectively, the “Subject Matter Experts”). The Sellers and the Purchasers shall cause their respective members on the Joint Remediation Committee to, and the Purchasers shall cause the Subject Matter Experts to, act in good faith in connection with the development of the Corrective Action Plan.

  • Statement of Grievance The grievance shall contain a statement of: 1. Specific situation, act or acts complained of as violation of this Agreement, or written rules, regulations or policies; 2. The damage suffered by the employee; and 3. The relief sought.

  • 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.

  • 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.

  • 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. (b) The local Joint Safety Committee shall consist of equal representation from Company and Union. This Committee shall meet at least once a month to consider all safety and occupational health problems.

  • Function of Joint Health and Safety Committee All incidents involving aggression or violence shall be brought to the attention of the Joint Health and Safety Committee. The Employer agrees that the Joint Health and Safety Committee shall concern itself with all matters relating to violence to staff.

  • 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.

  • INDEPENDENT ASSESSMENT COMMITTEE CHAIRPERSONS Xx. Xxxxxx Xxxxxxxxx Registered Nurses Association of Ontario 000 Xxxxxxxxxx Xxxxxx, Xxxxx 0000 Xxxxxxx, XX X0X 0X0 Telephone: (000) 000-0000, ext. 216 Fax: (000) 000-0000 E-mail: xxxxxxxxxxxxxx@xxxxxxxxx.xx Ms. Xxxxxxx Plain 0000 Xxxxxx Xxxx Xxxxxxxx, XX X0X 0X0 Telephone: (000) 000-0000 Email: xxxxxxx.xxxxx@xxxxxxxxx.xx BETWEEN: AND:

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