Protocol Amendment definition

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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Protocol Amendment means a written description of changes to or formal clarification of a protocol;
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Examples of Protocol Amendment in a sentence

  • The Protocol Amendment Summary of Changes Table for the current amendment is located directly before the Table of Contents.

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

  • Protocol Amendment No. 8 was implemented, as well as patient Information and Informed Consent Form for Czech republic was modified, which revised costs for the performance of the Study; and VZHLEDEM K TOMU, xx xxx implementován Dodatek Protokolu č.


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

  • Soil amendment means any substance that is intended to

  • General Amendment means an amendment made by XXXXX, from time to time, to these Licence Conditions, on notice to the Licensee.

  • Tariff Amendment means an amendment made by XXXXX, from time to time, to the tariff applicable to this Licence, on notice to the Licensee.

  • Material Amendment has the meaning provided in Section 9.6.

  • Addendum / Amendment means any written amendment / addendum /corrigendum to this RFP, from time to time issued by NMRC to the prospective bidders

  • Major Amendment means any change which is not a minor amendment.

  • 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.

  • Administrative permit amendment means an air quality operating permit revision that:

  • Ninth Amendment means that certain Ninth Amendment to Second Amended and Restated Credit Agreement, dated as of the Ninth Amendment Effective Date, among the Borrower, the Guarantors, the Administrative Agent and the Lenders party thereto.

  • Price amendment means the amendment to a registration statement filed under the Securities Act of 1933 or, if an amendment is not filed, the prospectus or prospectus supplement filed under the Securities Act of 1933 that includes a statement of the offering price, underwriting and selling discounts or commissions, amount of proceeds, conversion rates, call prices, and other matters dependent upon the offering price.

  • Tenth Amendment means that certain Tenth Amendment to Credit Agreement, dated as of November 15, 2019, among Holdings, the Borrower, the other Credit Parties party thereto, the Administrative Agent, the Collateral Agent and the Lenders party thereto.

  • Eighth Amendment means that certain Eighth Amendment to Credit Agreement, dated as of August 30, 2019, among the Borrower, the Lenders and the Administrative Agent.

  • Fifth Amendment means that certain Fifth Amendment to Credit Agreement, dated as of December 14, 2017, among Holdings, the Borrower, the Administrative Agent and the Lenders, Letter of Credit Issuers and other Credit Parties 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.

  • Fourth Amendment means that certain Fourth Amendment to Amended and Restated Credit Agreement dated as of the Fourth Amendment Effective Date among the Borrower, the Guarantors party thereto, the Administrative Agent and the Lenders party thereto.

  • Sixth Amendment means that certain Sixth Amendment to Credit Agreement, dated as of February 20, 2018, among Holdings, the Borrower, the Administrative Agent and the Lenders and other Credit Parties party thereto.

  • Seventh Amendment means that certain Seventh Amendment to Credit Agreement dated as of April [__], 2012, by and among the Borrowers, the other Loan Parties, the Agents and the Lenders.