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

  • 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.

  • 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.

  • Once your protocol is approved, any additional key personnel must be added by amendment (see UCSC IACUC Forms webpage for updated Protocol Amendment Form) prior to direct participation in the proposed activities.

  • 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.

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

  • Protocol Amendment: A written description of a change(s) to or formal clarification of a protocol.

  • Text revisions resulting from this amendment are incorporated in the body of Protocol Amendment 1.

  • The Sponsor will conduct an ongoing review of videotapes of psychotherapy sessions, entry criteria, vital signs, and reaction data for completed sessions and any AEs. The sponsor will provide ongoing feedback to the co-therapist teams to ensure proper therapist training, subject safety, and to ensure standardization of therapy techniques in the Sponsor’s ongoing effort to manualize MDMA-assisted psychotherapy.MAPS Study MP-12 Protocol Amendment 5 Version 1U.S. August 19, 2014 Table 2.


More Definitions of Protocol Amendment

Protocol Amendment means an amendment to the Protocol or Study, including the addition of a Study Arm.
Sample 1
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

  • 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.

  • L/C Amendment Application means an application form for amendment of outstanding Letters of Credit as shall at any time be in use at the Issuing Bank, as the Issuing Bank shall request.

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

  • 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

  • Additional Amendment shall have the meaning provided in Section 2.14(g)(iv).

  • ESG Amendment has the meaning specified in Section 2.18.

  • Amendment Agreement shall have the meaning assigned to such term in the recitals hereto.

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

  • First Amendment means that certain First Amendment to Credit Agreement, dated as of February 27, 2017, among the Loan Parties, the Administrative Agent and the Lenders party thereto.

  • Order Amendment means Our Authorised Order Amendment or series of Order Amendments, each Order Amendment having precedence over any earlier Order Amendment.

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

  • Ninth Amendment means the Ninth Amendment to Amended and Restated Senior Secured Credit Agreement, dated as of February 11, 2022, by and among Administrative Agent, Collateral Agent, Lenders, the Borrower, Parent and Guarantors.

  • 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 the Eighth Amendment to Second Amended and Restated First Lien Credit Agreement dated as of May 23, 2014 among the Borrower, EPL, the Lenders, the Administrative Agent and the other Persons party thereto.

  • Eleventh Amendment means that certain Eleventh Amendment to Credit Agreement, dated as of April 29, 2022, among Holdings, the Borrower, the other Credit Parties party thereto, the Administrative Agent, the Collateral Agent, the Lenders party thereto, the Revolving Letter of Credit Issuers and the various other parties party thereto.

  • Implementation Agreement means the Implementation Agreement dated ……… by and between the GOB, PGCB and the Company in connection with the Project, and also includes any amendment of it made from time to time;

  • Fifth Amendment means the Fifth Amendment to Fifth Amended and Restated Credit Agreement dated as of August 25, 2016, among the Borrower, the Lenders party thereto, the Administrative Agent and the other Persons 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 Credit Agreement, dated as of August 17, 2017, among Holdings, the Borrower, the Administrative Agent and the Lenders and other Credit Parties party thereto.

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

  • Sixth Amendment means the Sixth Amendment to Amended and Restated Senior Secured Credit Agreement, dated as of November 5, 2021, by and among Administrative Agent, Collateral Agent, Lenders, the Borrower, Parent and Guarantors.

  • Fundamental Amendment means, with respect to each Lender, any amendment, modification, waiver or supplement of or to this Agreement or any Facility Document 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 or a pricing grid), (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,” “Maximum Available Amount,” “Advance Rate,” “Borrowing Base,” “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 4 Borrowing Base,” “Class 1 Loan,” “Class 2 Loan”, “Class 3 Loan,” or “Class 4 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.

  • Second Amendment Agreement means that certain Second Amendment Agreement dated as of October 4, 2011, among Xxxxx 0, xxx Xxxxxxxx, Xxxxxxx Xxxxx Capital Corporation, as administrative agent and collateral agent, and the Tranche B II Term Lenders party thereto, providing for, among other things, the amendment and restatement of the 2009 Credit Agreement.