Protocol Amendment definition

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 shall be managed by means of the change control procedure set out in this Clause.

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

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 Pfizer and the responsible Ethics Committee and SUKL (as applicable) and documented in a written 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.

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

• Where the Sponsor originates a Change Request, the Trial Site 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 Clinical Trial and the other terms of this Agreement.

• 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 Clinical Trial and the other terms of this Agreement.

More Definitions of Protocol Amendment

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.

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