Common use of EC Approval Clause in Contracts

EC Approval. The Study shall not commence until Institution has obtained in writing EC approval of the terms and conditions of the Study, including the Informed Consent and related instructions for use; the Protocol; and the participation of Institution and any Research Personnel in the Study. All modifications to the Protocol shall be made by the Sponsor and shall not be implemented by any Investigator until receipt of any necessary FDA or EC approvals. Modifications to the Informed Consent shall be agreed upon by the Sponsor and the Principal Investigator, and shall not be implemented by any Investigator until receipt of EC written approval. Institution agrees that any conditions of approval imposed by the EC shall be adhered to.

Appears in 2 contracts

Samples: Clinical Trial Research Agreement, Clinical Trial Research Agreement

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EC Approval. The Study shall not commence until Institution has obtained in writing EC approval of the terms and conditions of the Study, including the Informed Consent and related instructions for use; the Protocol; and the participation of Institution and any Research Personnel in the Study. All modifications to the Protocol shall be made by the Sponsor and shall not be implemented by any Investigator until receipt of any necessary FDA or EC approvals. Modifications to the Informed Consent shall be agreed upon by the Sponsor and the Principal Investigator, and shall not be implemented by any Investigator until receipt of EC written approval. Institution agrees that any conditions of approval imposed by the EC shall be adhered to.3.1

Appears in 1 contract

Samples: Clinical Trial Research Agreement

EC Approval. The Study shall not commence until Institution the Sponsor or Sponsor representative has obtained in writing EC approval of the terms and conditions of the Study, including the Informed Consent and related instructions for useperforming the Study; the Protocol; and the participation of Institution Service Provider and any Research Personnel in the Study. All modifications to the Protocol shall be made by the Sponsor and shall not be implemented by any Investigator until receipt of any necessary FDA regulatory approvals, including SÚKL or EC approvals. Modifications to the Informed Consent shall be agreed upon by the Sponsor and the Principal Investigator, and shall not be implemented by any Investigator until receipt of EC written approval. Institution Service Provider agrees that any conditions of approval imposed by the EC shall be adhered to.

Appears in 1 contract

Samples: Clinical Trial Research Agreement

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EC Approval. The Study shall not commence until Institution Sponsor has obtained in writing EC approval of the terms and conditions of the Study, including the Informed Consent and related instructions for use; the Protocol; and the participation of Institution and any Research Personnel in the Study. All modifications to the Protocol shall be made by the Sponsor and shall not be implemented by any Investigator until receipt of any necessary FDA regulatory authority or EC approvals. Modifications to the Informed Consent shall be agreed upon by the Sponsor and the Principal Investigator, and shall not be implemented by any Investigator until receipt of EC written approval. Institution agrees that any conditions of approval imposed by the EC shall be adhered to.

Appears in 1 contract

Samples: Clinical Trial Research Agreement

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