Protocol Amendment definition

Protocol Amendment means a written description of changes to or formal clarification of a protocol;
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Protocol Amendment shall be managed by means of the change control procedure set out in this Clause.
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Protocol Amendment shall be managed by means of the change control procedure set out in this Clause. For the purposes of this Agreement, a “Change Request” is a request to change the obligations of the Parties arising from a Protocol Amendment. Where the Sponsor or CRO originates a Change Request, the Trial Site shall provide the Sponsor or CRO, within fourteen (14) days of receiving the Change Request, details of the impact that the proposed Protocol Amendment will have upon the costs of carrying out the Clinical Trial and the other terms of this Agreement. A Change Request shall become a “Change Order” when the requirements of the change control procedure have been satisfied and any necessary change to this Agreement is signed by the authorised representatives of all Parties. An amended financial appendix shall be signed and appended to this Agreement according to Clause 12.2 above. This Agreement contains the entire understanding between the Parties. This Agreement supersedes all other agreements, negotiations, representations and undertakings, whether written or oral, of prior date between the Parties relating to the Clinical Trial that is the subject of this Agreement, other than the agreement contracting the CRO to work on behalf of the Sponsor with regards to this Clinical Trial or where a separate Investigator Site within the Trial Site has been contracted, in which case the Agreement does not supersede that / those agreement(s).
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Examples of Protocol Amendment in a sentence

  • Any emergency deviation will be followed by written Protocol Amendment.

  • For the purposes of this Agreement, a “change request” is a request to change the obligations of the Parties arising from a Protocol Amendment.

  • For the purposes of this Agreement, a ‘change request’ is a request to change the obligations of the Parties arising from a Protocol Amendment.

  • For the purposes of this Agreement, a “Change Request” is a request to change the obligations of the Parties arising from a Protocol Amendment.

  • No such change made for the safety of Study Subjects currently under treatment will be applied to any future Study Subjects unless it is approved by CRO and/or Pfizer and the responsible Ethics Committee and SUKL (as applicable) and documented in a written Protocol Amendment.

  • Where the Sponsor originates a change request, the Participating Organisation shall provide the Sponsor, within fourteen (14) days of receiving the change request, details of the impact that the proposed Protocol Amendment will have upon the costs of carrying out the Non-Interventional Study and the other terms of this Agreement.

  • Where the Sponsor or CRO originates a change request, the Participating Organisation shall provide the Sponsor or CRO, within fourteen (14) days of receiving the change request, details of the impact that the proposed Protocol Amendment will have upon the costs of carrying out the Non-Interventional Study and the other terms of this Agreement.

  • No such change made for the safety of Study Subjects currently under treatment will be applied to any future Study Subjects unless it is approved by Pfizer and the responsible Ethics Committee and SUKL (as applicable) and documented in a written Protocol Amendment.

  • To account for changes to the budget resulting from Protocol Amendment 5, Exhibit A, “Budget and Payment Terms”, of the Agreement is hereby stricken in its entirety and replaced with the revised “Budget and Payment Terms” attached hereto as Exhibit A.

  • Where the Sponsor originates a change request, the Participating Organisation shall provide the Sponsor, within thirty-five (35) days of receiving the change request, details of the impact that the proposed Protocol Amendment will have upon the costs of carrying out the Clinical Trial and the other terms of this Agreement.


More Definitions of Protocol Amendment

Protocol Amendment means an amendment to the Protocol or Study, including the addition of a Study Arm.
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Protocol Amendment shall be managed by means of the change control procedure set out in this Clause. For the purposes of this Agreement, a “Change Request” is a request to change the obligations of the Parties arising from a Protocol Amendment. Where the Sponsor or CRO originates a Change Request, the Participating Organisation shall provide the Sponsor or CRO, within fourteen (14) days of receiving the Change Request, details of the impact that the proposed Protocol Amendment will have upon the costs of carrying out the Non-Interventional Study and the other terms of this Agreement. A Change Request shall become a “Change Order” when the requirements of the change control procedure have been satisfied and any necessary change to this Agreement is signed by the authorised representatives of all Parties. An amended financial appendix shall be signed and appended to this Agreement according to Clause 12.2 above. This Agreement contains the entire understanding between the Parties and supersedes all other agreements (other than the agreement contracting the CRO to work on behalf of the Sponsor with regards to this Non-Interventional Study), negotiations, representations and undertakings, whether written or oral, of prior date between the Parties relating to the Non-Interventional Study that is the subject of this Agreement.
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Related to Protocol Amendment

  • Incremental Amendment has the meaning set forth in Section 2.14(f).

  • ESG Amendment has the meaning specified in Section 2.18.

  • First Amendment means that certain First Amendment to Credit Agreement, dated as of September 19, 2016, among the Borrower, the Administrative Agent and the Lenders party thereto.

  • Amendment and Restatement Agreement means the Amendment and Restatement Agreement, dated as of January 29, 2016, among the Borrowers, the Lenders party thereto and the Administrative Agent.

  • Restatement Agreement has the meaning set forth in the introductory statement of this Agreement.

  • Fundamental Amendment means, with respect to each Lender, any amendment, modification, waiver or supplement of or to this Agreement that would (a) increase or extend the term of the Individual Lender Maximum Funding Amounts or change the Final Maturity Date (other than an increase of the Individual Lender Maximum Funding Amount of a particular Lender or the addition of a new Lender agreed to by the relevant Lender), (b) extend the date fixed for the payment of principal of or interest on any Advance or any fee hereunder, (c) reduce the amount of any such payment of principal, (d) reduce the rate at which Interest is payable thereon or any fee is payable hereunder (other than in connection with the appointment of a Benchmark Replacement), (e) release any material portion of the Collateral, except in connection with dispositions permitted hereunder, (f) alter the terms of Section 9.01 or Section 13.01(b), (g) modify the definition of the terms “Majority Lenders,” “Required Lenders,” “Maximum Available Amount,” “Advance Rate,” “Borrowing Base,” “Minimum OC Coverage Test,” “Collateral Quality Test,” “Collateral Loan,” “Eligible Collateral Loan,” “Eligible Country,” “Class 1 Borrowing Base,” “Class 2 Borrowing Base,” “Class 3 Borrowing Base,” “Class 1 Minimum OC Coverage Test,” “Class 2 Minimum OC Coverage Test,” “Class 3 Minimum OC Coverage Test,” “Class 1 Loan,” “Class 2 Loan” or “Class 3 Loan” or any component thereof defined therein (in each case, other than any administrative, non-material amendment agreed to by the Borrower and the Administrative Agent); (h) modify in any other manner the number or percentage of the Lenders required to make any determinations or waive any rights hereunder or to modify any provision hereof or (i) extend the Reinvestment Period, in each case to the extent such amendment, modification, waiver or supplement relates to such Lender.

  • Seventh Amendment means that certain Amendment No. 7 to Amended and Restated Credit Agreement, by and among Borrowers, Lenders, and Administrative Agent, dated July 31, 2012.