Doplňování Protokolu Sample Clauses

Doplňování Protokolu. Zdravotnické zařízení není bez předchozího písemného souhlasu Biogen oprávněno jakkoliv měnit či doplňovat Protokol, ani to nesmí umožnit Zkoušejícímu či kterémukoliv jinému členu Personálu, s výjimkou případů, kdy tak vyžaduje zákon v zájmu ochrany bezpečnosti, zdraví či práv daných Subjektů. Zdravotnické zařízení a Zkoušející budou veškeré údaje zaznamenávat do formuláře poskytnutého společností Biogen nebo jejím jménem (Case Report Form, dále jen „CRF“). Originál CRF bude určen pro společnost Biogen a kopii si ponechá ve svých záznamech Zkoušející. Po doručení konečného CRF Zkoušejícím budou jakékoliv změny databáze prováděny prostřednictvím upřesňujícího formuláře, který poskytne CRO. (f)
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Doplňování Protokolu. Zdravotnické zařízení není bez předchozího písemného souhlasu Biogen oprávněn jakkoliv měnit či doplňovat Protokol, ani to nesmí umožnit Zkoušejícímu či kterémukoliv jinému členu Personálu, s výjimkou (f) 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, případů, kdy tak vyžaduje zákon v zájmu ochrany bezpečnosti, zdraví či práv daných Subjektů. Zdravotnické zařízení a Zkoušející budou veškeré údaje zaznamenávat do formuláře poskytnutého společností Biogen nebo jejím jménem (Case Report Form, dále jen „CRF“). Originál CRF bude určen pro společnost Biogen a kopii si ponechá ve svých záznamech Zkoušející. Po doručení konečného CRF Zkoušejícím budou jakékoliv změny databáze prováděny prostřednictvím upřesňujícího formuláře poskytnutého CRO. 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.

Related to Doplňování Protokolu

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