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 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 Sponsor may amend the Protocol at any time. Any such amendment shall be in writing and sent to the Institution. 1.5 Dodatek k protokolu. Zadavatel může protokol kdykoliv doplnit formou dodatku. Každý takový dodatek bude učiněn písemně a bude zaslán zdravotnickému zařízení.
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 Joint CARIFORUM-EC Council may decide to amend the provisions of this Protocol.
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. 1.5
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.
Amendment of the Protocol. The Institution 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 Biogen, unless required by law to protect the safety, health or rights of the Subjects. The Institution shall, and shall cause the Investigator to 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
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.
