Modification of the Protocol Sample Clauses

Modification of the Protocol. Any changes that arise after the approval of the protocol must be documented as protocol amendments. The FDA or other applicable regulatory agencies must be notified of protocol amendments. The changes will become effective only after approval of the Sponsor, the investigator, the IRB/EC, and where necessary, the applicable regulatory agency. In cases when the protocol is modified to enhance patient safety, changes may be implemented and the amendment must be immediately submitted to the IRB/EC. The investigator is responsible for informing the IRB/EC of all problems involving risks to patients according to national legislation. In case of urgent safety measures, the Sponsor will immediately notify the investigators and relevant regulatory agencies, including FDA in accord with 21 CFR 312.32.
Sample 1
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Modification of the Protocol. Any modification of this Protocol must be made in writing and previously approved by the competent corporate bodies of each of the Parties, with the abstention, if appropriate, of the members of those corporate bodies of each of the Parties that represent the other Party, or that may have been appointed at the proposal of the other Party.
Sample 1
Modification of the Protocol. Any changes in this research activity, except those necessary to remove an apparent immediate hazard to the patient, require a protocol amendment signed by the principal study investigator and research institution investigator, and approved by the IRB (or equivalent) before implementation.
Sample 1
Modification of the Protocol. Any changes in this research activity, except those necessary to remove an apparent immediate hazard to the subject, must be reviewed and approved by SIGA or designee. Amendments to the protocol must be submitted in writing to the IRB for approval before subjects are enrolled into an amended protocol.
Sample 1

Related to Modification of the Protocol

  • Modification of the Programme 1. Unless otherwise explicitly stipulated in this programme agreement, any modification of the Programme is subject to prior approval by the FMC.

  • Modification of the Small Generating Facility The Interconnection Customer must receive written authorization from the NYISO and Connecting Transmission Owner before making any change to the Small Generating Facility that may have a material impact on the safety or reliability of the New York State Transmission System or the Distribution System. Such authorization shall not be unreasonably withheld. Modifications shall be done in accordance with Good Utility Practice. If the Interconnection Customer makes such modification without the prior written authorization of the NYISO and Connecting Transmission Owner, the Connecting Transmission Owner shall have the right to temporarily disconnect the Small Generating Facility. If disconnected, the Small Generating Facility will not be reconnected until the unauthorized modifications are authorized or removed.

  • Modification of the Service We may discontinue, add to or revise any or all aspects of the Service in our sole discretion and without notice, including, without limitation, access to support services, publications and any other products or services ancillary to the Service. In particular, we reserve the right in our sole discretion to modify, supplement, delete, discontinue or remove any software, file, publications, information, communication or other content that we or one of our vendors provide to you in connection with the Service. If we undertake any of these changes, we may, but are not required to, notify you by e-mail, posting a notice on one or more of the Viasat websites or other electronic notice. If you do not agree to the identified changes, then you must cancel your subscription and stop using the Service prior to the effective date of the changes. Your use of the Service after the effective date of the changes constitutes your acceptance of the changes. In addition, we may take any action consistent with our Acceptable Use, Data Allowance, Bandwidth Usage and Unlimited Data Policies, and Viasat Shield Application End User Terms and Conditions Agreement, , including, without limitation, actions to (a) prevent unsolicited bulk e-mailing from entering or leaving any e-mail account or the network e-mail system, (b) delete e-mail messages if your e-mail account has not been accessed by you within a time established by us from time to time, in our sole discretion, (c) instruct our system not to process e-mail or instant messages due to space limitations, (d) make available to third parties information relating to Viasat or its customers, (e) withdraw, change, suspend or discontinue any functionality or feature of the Service,

  • Modification of Budget Upon written approval of County, Subrecipient shall have the authority to transfer allocated program funds from one category of the overall program Budget to another category of the overall Budget. No such transfer may be made without the express prior written approval of County. A modification of the Budget may include the addition of any new Budget category.

  • MODIFICATION OF THE CONTRACT 1. Any modification of this contract or its annexes, including additions or deletions, shall require a supplementary written agreement concluded on the same terms as the contract. No oral agreement may bind the parties for that purpose.

  • CONSTRUCTION OF THE PROJECT The Allottee has seen the proposed layout plan, specifications, amenities and facilities of the Apartment/ Plot and accepted the floor plan, payment plan and the specification, amenities and facilities annexed along with this Agreement which has been approved by the competent authority, as represented by the Promoter. The Promoter shall develop the Project in accordance with the said layout plans, floor plans and specifications, amenities and facilities. Subject to the terms in this Agreement, the Promoter undertakes to strictly abide by such plans approved by the competent authorities and shall also strictly abide by the bye-laws, FAR, and density norms and provisions prescribed by the relevant building bye-laws and shall not have an option to make any variation/ alteration/ modification in such plans, other than in the manner provided under the Act, and breach of this term by the Promoter shall constitute a material breach of this Agreement.

  • Duration of the Processing Personal Data will be Processed for the duration of the Agreement, subject to Section 4 of this DPA.

  • Modification of the Agreement Notwithstanding any of the provisions of this Agreement, the parties may agree to amend this Agreement. No alteration or variation of the terms of this Agreement shall be valid unless made in writing and signed by the parties hereto. No oral understanding or agreement not incorporated herein shall be binding on any of the parties hereto.

  • Implementation of the Agreement Regulations of this Agreement relating to investments who investors of one Contracting Party realized before or after the entry into force of this Agreement, with what shall apply from the moment of its entry into force, provided that such investments conducted in accordance with the laws of that Party Contracting.

  • Execution of the Project Section 3.01. (a) The Borrower declares its commitment to the objectives of the Project as set forth in Schedule 2 to this Agreement, and, to this end, shall carry out the Project with due diligence and efficiency and in conformity with appropriate administrative, financial, banking, accounting and environmental practices, and shall provide, promptly as needed, the funds, facilities, services and other resources required for the Project.

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