Common use of Amendment of the Protocol Clause in Contracts

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 InstitutionFoundation 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 IdecBiogen, unless required by law to protect the safety, health or rights of the Subjects. The Institution InstitutionFoundation shall, and shall cause the Investigator shall to, 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).. (f)