Reviewing HREC definition

Reviewing HREC means the Human Research Ethics Committee reviewing the Study on behalf of the Institution as described in Schedule 1.
Sample 1Sample 2Sample 3
Reviewing HREC means the Human Research Ethics Committee responsible for the ethical review and approval of a research project under NMA;
Sample 1Sample 2

Examples of Reviewing HREC in a sentence

  • The Institution will ensure that the Study is subject to the continuing oversight of the Reviewing HREC throughout its conduct.

  • The Institution will make available adequate facilities, equipment and any other resource of the Institution reasonably required to safely follow the Protocol, provided that any amendments to the Protocol which take place after the execution of this Agreement and requiring any additional use of facilities, equipment, staff or resources, have been approved in writing by the Institution and the Reviewing HREC.

  • Except where the modification is necessary to eliminate an immediate hazard to Study Participants, or involves only logistical or administrative aspects of the trial, any modification may not be implemented before approval by the Reviewing HREC.

  • The parties must comply with, and conduct the Study in accordance with, the Protocol and any conditions of the Reviewing HREC.

  • The Sponsor will cooperate with the Institution and/or the Reviewing HREC in investigating any Adverse Event (including Serious Adverse Event) arising out of or in connection with the Study.

  • Subject to clause 9, the Institution will allow regular monitoring visits in accordance with the GCP Guideline, access for the purposes of audit and as required by Regulatory Authorities or as specified in the Protocol and permit access to the Essential Documents (including original records), Study records, reports, other Study related materials and its Personnel as soon as is reasonably possible upon request by the Sponsor, Regulatory Authority, Reviewing HREC or any third party designated by the Sponsor.

  • If there is a need for such a deviation the Institution must notify the Sponsor and the Reviewing HREC of the facts and circumstance causing the deviation as soon as is reasonably practical, but in any event no later than 5 working days after the change is implemented.

  • The Sponsor will provide indemnity to the Institution and members of the Reviewing HREC against claims arising from the Study on the terms and conditions set out in the relevant Medicines Australia Form of Indemnity for Clinical Trials as set out in Schedule 3.

  • SPONSOR OBLIGATIONS AND RESPONSIBILITIES Prior to the Agreement being executed, the Sponsor must provide the Principal Investigator, and, through the Principal Investigator, the Institution and the Reviewing HREC, with all current and relevant information regarding the Investigational Product as reasonably required to justify the nature, scope and duration of the Study.

  • The parties must comply with, and conduct the Study in accordance with the Protocol and any conditions of the Reviewing HREC.

Related to Reviewing HREC

  • Reviewing Party means any appropriate person or body consisting of a member or members of the Company's Board of Directors or any other person or body appointed by the Board of Directors who is not a party to the particular Claim for which Indemnitee is seeking indemnification, or Independent Legal Counsel.

  • Reviewing Authority means the Alberta Securities Commission.

  • Expert Determination the process described in Paragraph 6 of Schedule 8.3 (Dispute Resolution Procedure);

  • Adverse determination shall have the meaning set forth in Section 19.7.

  • Independent adjuster means an insurance adjuster required to be licensed under

  • Initial determination means the first child custody determination concerning a particular child.

  • Adverse Benefit Determination means any of the following:

  • Final Adverse Determination means an Adverse Determination involving a Covered Service that has been upheld by Blue Cross and Blue Shield or its designated utilization review organization, at the completion of Blue Cross and Blue Shield's internal grievance process procedures.

  • Reviewing official means the individual who shall make the trustworthiness and reliability determination of an individual to determine whether the individual may have, or continue to have, unescorted access to the Category 1 or Category 2 quantities of radioactive materials that are possessed by the licensee.

  • Independent Accounting Firm has the meaning set forth in Section 2.05(c).

  • Self-Determination means a philosophy and process by which individuals with developmental disabilities are empowered to gain control over the selection of support services that meet their needs. The basic principles of self-determination are:

  • Final Adverse Benefit Determination means an adverse benefit determination that is upheld at the completion of a health plan issuer’s internal appeals process.

  • Appeal Board means the State Charter School Appeal

  • Flood Elevation Determination means a determination by the Administrator of the water surface elevations of the base flood, that is, the flood level that has a one percent or greater chance of occurrence in any given year.

  • Independent Counsel as defined in Section 2 of this Agreement. In either event, Indemnitee or the Company, as the case may be, may, within ten (10) days after such written notice of selection shall have been received, deliver to the Company or to Indemnitee, as the case may be, a written objection to such selection; provided, however, that such objection may be asserted only on the ground that the Independent Counsel so selected does not meet the requirements of “Independent Counsel” as defined in Section 2 of this Agreement, and the objection shall set forth with particularity the factual basis of such assertion. Absent a proper and timely objection, the person so selected shall act as Independent Counsel. If such written objection is so made and substantiated, the Independent Counsel so selected may not serve as Independent Counsel unless and until such objection is withdrawn or a court of competent jurisdiction has determined that such objection is without merit. If, within twenty (20) days after submission by Indemnitee of a written request for indemnification pursuant to Section 11(b) hereof, no Independent Counsel shall have been selected and not objected to, either the Company or Indemnitee may petition the Delaware Court for resolution of any objection which shall have been made by the Company or Indemnitee to the other’s selection of Independent Counsel and/or for the appointment as Independent Counsel of a person selected by the Delaware Court, and the person with respect to whom all objections are so resolved or the person so appointed shall act as Independent Counsel under Section 12(a) hereof. Upon the due commencement of any judicial proceeding or arbitration pursuant to Section 14(a) of this Agreement, Independent Counsel shall be discharged and relieved of any further responsibility in such capacity (subject to the applicable standards of professional conduct then prevailing).

  • SOFR Determination Date has the meaning specified in the definition of “Daily Simple SOFR”.

  • Determination means the written documentation of a decision of a procurement officer including findings of fact required to support a decision. A determination becomes part of the procurement file to which it pertains.

  • Final Determination means the final resolution of liability for any Tax for any taxable period, by or as a result of (i) a final and unappealable decision, judgment, decree or other order by any court of competent jurisdiction; (ii) a final settlement with the IRS, a closing agreement or accepted offer in compromise under section 7121 or section 7122 of the Code, or a comparable agreement under the laws of other jurisdictions, which resolves the entire Tax liability for any taxable period; (iii) any allowance of a refund or credit in respect of an overpayment of Tax, but only after the expiration of all periods during which such refund may be recovered by the jurisdiction imposing the Tax; or (iv) any other final disposition, including by reason of the expiration of the applicable statute of limitations.

  • Standard of Conduct Determination shall have the meaning ascribed to it in Section 9(b) below.

  • SOFR Determination Time means 3:00 p.m. (New York time) on the U.S. Government Securities Business Day, at which time Compounded SOFR is published on the FRBNY’s Website.

  • Final Determination Date means the following:

  • Audit Committee Financial Expert means a person who has the following attributes:

  • Administrative merits determination means certain notices or findings of labor law violations issued by an enforcement agency following an investigation. An administrative merits determination may be final or be subject to appeal or further review. To determine whether a particular notice or finding is covered by this definition, it is necessary to consult section II.B. in the DOL Guidance.

  • Claim Determination Period means a calendar year. However, it does not include any part of a year during which a person has no coverage under This Plan, or any part of a year before the date this COB provision or a similar provision takes effect.

  • Adverse decision means a decision reducing,