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.
Appears in 3 contracts
Samples: Clinical Trial Agreement, Clinical Trial Agreement, Clinical Trial Agreement
Amendment of the Protocol. The Institution or the Investigator 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 CROCRO based on a Power of Attorney, which forms an integral part of this Agreement.
Appears in 2 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, unless required by law to protect the safety, health or rights of the Subjects. The Institution and acknowledges that the Investigator shall will be/is responsible 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 a copy for retention in the Investigator’s files. Following delivery of the final CRF by the InvestigatorCRF, any changes to the database shall be via a clarification form provided by the CRO.
Appears in 1 contract
Samples: Clinical Trial Agreement
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 shall, and shall cause the Investigator shall 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 a copy for retention in the Investigator’s files. Following delivery of the final CRF by the InvestigatorCRF, any changes to the database shall be via a clarification form provided by the CRO.
Appears in 1 contract
Samples: Clinical Trial Agreement
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 the Applicable laws and regulations 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.
Appears in 1 contract
Samples: Clinical Trial Agreement
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 the Applicable laws and regulations 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.
Appears in 1 contract
Samples: Clinical Trial Agreement