Amendment of the Protocol Clause Samples
The "Amendment of the Protocol" clause defines the process by which changes or modifications can be made to the existing protocol agreement. Typically, this clause outlines the requirements for proposing amendments, such as who may initiate them, the form they must take, and the level of consent or approval needed from the parties involved—often requiring written agreement or a specified majority. Its core practical function is to provide a clear and orderly mechanism for updating the protocol, ensuring that all parties understand how changes can be made and preventing unauthorized or unilateral modifications.
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Amendment of the Protocol. The Sponsor may amend the Protocol at any time. Any such amendment shall be in writing and sent to the Institution/Principal Investigator.
Amendment of the Protocol. The Institution shall not alter or amend, and shall not permit the Investigator or any member of the Staff to alter or amend, the Protocol in any way without the prior written consent of Biogen, unless required by law to protect the safety, health or rights of the Subjects. The Institution and the Investigator shall record all data on a form provided by or on behalf of Biogen (Case Report Form or CRF). The original CRF shall be designated for Biogen and a copy for retention in the Investigator’s files. Following delivery of the final CRF by the Investigator, any changes to the database shall be via a clarification form provided by the CRO.
Amendment of the Protocol. The Sponsor may amend the Protocol at any time. Any such amendment shall be in writing and sent to the Institution, and will not take effect until approved by the IRB. Following any such amendment to the Protocol, either Party may propose a related amendment to this Agreement (including the Payment Schedule, as defined in Section 11). The Parties shall negotiate in good faith with respect to any such proposed amendment. If the Parties are unable to agree upon such an amendment to this Agreement, either Party may terminate this Agreement pursuant to Article 12.
Amendment of the Protocol. The Sponsor shall be entitled to make changes to the Protocol only by written amendments. In the event of a substantial amendment to the Protocol, the Sponsor shall be obliged to notify the relevant authorities (SÚKL, ethics committees) and to meet other requirements stipulated by applicable regulations before applying the amendment. At the same time, the Sponsor shall be obliged to inform in writing the Institution and the Principal Investigator of any changes in the Protocol or Study Information. Substantial amendments to the Protocol can be made only based on 1.5 Dodatek k protokolu. Zadavatel má právo provádět změny protokolu pouze prostřednictvím písemných dodatků. V případě podstatné změny protokolu je zadavatel povinen oznámit před uplatněním dodatku tyto změny příslušným orgánům (SUKL, etické komise) a splnit i další požadavky stanovené platnými předpisy. Současně je zadavatel povinen písemně informovat o jakýchkoli změnách v protokolu nebo Souboru informací zdravotnické zařízení a hlavního zkoušejícího. Podstatné změny v protokolu je možné provést pouze na základě dohody agreement between the Parties. mezi smluvními stranami.
Amendment of the Protocol. The Institution shall not alter or amend, and shall not permit the Investigator or any member of the Staff to alter or amend, the Protocol in any way without the prior written consent of Biogen Idec, unless required by law to protect the safety, health or rights of the Subjects. The Institution and the Investigator shall record all data on a form provided by or on behalf of Biogen Idec (Case Report Form or CRF). The original CRF shall be designated for Biogen Idec and a copy for retention in the Investigator’s files. Following delivery of the final CRF by the Investigator, any changes to the database shall be via a clarification form provided by a clinical research organization appointed by Biogen Idec in relation to the Trial (CRO).
Amendment of the Protocol. The Institution shall not alter or amend, and shall not permit the Principal Investigator or any member of the Staff to alter or amend, the Protocol in any way without the prior written consent of Hexal, unless required by law to protect the safety, health or rights of the Subjects.
Amendment of the Protocol. The Sponsor may amend the Protocol at any time. Any such amendment shall be in writing and sent to the Institution/Principal Investigator. Should any such Protocol amendment mandate approval of the State institute for Drug Control and/or of the Ethics Committee, Sponsor shall obtain respective approvals.
Amendment of the Protocol. The lnstitution shall not alter or amend, and shall not permit the Staff to alter or amend, the Protocol in any way without the prior written consent of Hexal, unless required by law to protect the safety, health or rights of the Subjects. Case Report Forms. The lnstitution shall ensure that the Principal lnvestigator, records all data on a fonn provided by or on behalf of Hexal (Case Report Form or CRF). Where hard copies are being used, the original CRF shall be designated for Hexal and a copy for retention in the Principal lnvestigator's files. Following delivery of the final CRF by the Principal Investigator, any changes to the database shall be via a clarification form provided by Hexal or CRO. Where electronic CRF or "e CRF" are being used, the Principal lnvestigator shall complete data in the e CRF within three (3) days after a Subject visit. Upon Trial completion, Hexal directly or through CRO shall request the Principal Investigator to sign a final statement confirming accuracy of the data provided in the eCRF before database lock. After final database lock, the Principal Investigator will be provided with a CD containing completed eCRFs of all subjects for archiving.
Amendment of the Protocol. Any modification to the Protocol which may impact the performance of the Study will require a formal amendment agreed upon by the Parties and shall not take effect until approved by the IRB.
Amendment of the Protocol. 5.1 The Protocol shall be amended solely by the Sponsor Representative, who shall communicate such amendments in writing to the FDA-CVM.
5.2 Before making any material amendment to the Protocol (as that term is defined in the Protocol), including to the Protocol’s Standard Operating Procedures, Oxitec will make reasonable efforts to present the amendment and its rationale to the Steering Committee to permit discussion before finalising the amendment. The Sponsor Representative will notify in writing (including by email) the Project Manager and all members of the Steering Committee of all amendments, whether or not material and whether or not discussed by the Steering Committee, within 3 working days of the amendment being made.
5.3 If FKMCD is dissatisfied with or would like to change any aspect of the Protocol, it will raise the concern and/or any proposed amendment with the Steering Committee.
5.4 Any amendment shall be deemed to be incorporated into the Protocol and/or Standard Operating Procedures only after the Sponsor Representative notifies the Project Manager as provided in this Section 5.