Participating Staff. The Institution and Investigator declares that he has the required experience for conducting the Trial and that he will duly perform the subject matter of this Agreement. The Institution shall not be able to replace the Investigator with another Investigator without the prior written consent of Biogen. The Institution and Investigator shall provide Biogen and its representatives with information regarding the staff participating in the Trial (the Staff). For the avoidance of doubt, the Staff shall throughout the term of this Agreement be under the supervision and control of the Institution and the Investigator, and the Institution and Investigator shall without limitation be responsible for ensuring that the Staff act in accordance with the Applicable Laws and Regulations and, Biogen’s and its representatives’ reasonable instructions. Zdravotnické zařízení pověří příslušně kvalifikovaného zaměstnance a člena Personálu v pozici farmaceuta k zajištění řádného zacházení a následného výdeje Produktu dle požadavků Zkoušejícího, v souladu se Správnou lékárenskou praxí (vyhláška č. 84/2008 Sb.), Platnými zákony a předpisy a ustanoveními Protokolu. The Institution will authorize an employee and member of the Staff appropriately qualified to act as the pharmacist to secure proper handling and subsequent distribution of the Product as requested by the Investigator, and in accordance with Good Pharmacy Practice (Regulation No. 84/2008 Coll.), Applicable Laws and Regulations and the provisions of the Protocol.
Participating Staff. The Investigator hereby declares that he/she has the required experience for conducting the Trial. The Institution and Investigator shall duly perform the conditions of this Agreement. The Institution shall not be able to replace the Investigator with another Investigator without the prior written consent of Biogen. The Institution shall provide, and shall cause the Investigator to provide, Biogen and its representatives with information regarding the staff participating in the Trial (the Staff). For the avoidance of doubt, the Staff shall throughout the term of this Agreement be under the supervision and control of the Investigator, and Investigator shall without limitation be responsible for ensuring that the Staff act in accordance with the Applicable Laws and Regulations, guidelines issued by the State Institute for Drug Control – LEK-12 and, Biogen’s and its representatives’ reasonable instructions. (b) Xxxxxxxxxx xxxxxxxx. Xxxxxxxxxx xxxxx xxxxxxxxxx, xx má požadované zkušenosti pro provádění Klinického hodnocení. Zdravotnické zařízení a Zkoušející budou tuto smlouvu řádně plnit. Zdravotnické zařízení nesmí Zkoušejícího nahradit jiným Zkoušejícím bez předchozího písemného souhlasu společnosti Biogen. Zdravotnické zařízení bude společnosti Biogen a jejím zástupcům poskytovat (a zajistí, aby tak činil i Zkoušející) informace ohledně pracovníků podílejících se na Klinickém hodnocení (dále jen „Personál“). Aby se předešlo jakýmkoliv pochybnostem, bude Personál po dobu trvání této smlouvy pod dozorem a kontrolou Zkoušejícího a Zkoušející ponese neomezenou odpovědnost za to, že Personál bude jednat v souladu s příslušnými zákony a právními předpisy, pokynu vydaného SÚKL č. LEK-12 a podle pokynů společnosti Biogen či jejích zástupců. The Institution will authorize an employee and member of the Staff appropriately qualified to act as the pharmacist to secure proper handling and subsequent distribution of the Product as requested by the Investigator, and in accordance with Good Pharmacy Practice (Regulation No. 84/2008 Coll.), Applicable Laws and Regulations and the provisions of the Protocol. Zdravotnické zařízení pověří příslušně kvalifikovaného zaměstnance a člena Personálu v pozici farmaceuta k zajištění řádného zacházení a následného výdeje Produktu dle požadavků Zkoušejícího, v souladu se Správnou lékárenskou praxí (vyhláška č. 84/2008 Sb.), Platnými zákony a předpisy a ustanoveními Protokolu.
Participating Staff. The Institution shall appoint the Investigator as the medical specialist responsible for the conduct of the Trial on its own responsibility. The Institution hereby declares that the Investigator has undergone the necessary training and has the required experience and means for conducting the Trial. The Institution shall guarantee that the Trial will be duly performed by the Investigator in accordance with this Agreement. The Institution shall not be able to replace the Investigator with another investigator without the prior written consent of Biogen. The Institution shall provide, and shall cause the Investigator to provide, Biogen and its representatives with information regarding the other staff participating in the Trial (the Investigator and the other staff collectively referred to as the Staff). For the avoidance of doubt, the Staff shall throughout the term of this Agreement be under the supervision and control of the Institution, and the Institution shall without limitation be responsible for ensuring that the Staff act in accordance with the Applicable Laws and Regulations and, Biogen’s and its representatives’ reasonable instructions. The Institution acknowledges and agrees that the Investigator enters into a separate agreement with Biogen and the CRO under which he/she will receive direct payment from the CRO for the services performed by the Investigator in connection with the Trial and by the other Staff members. The Investigator shall be responsible for the compensation of any Staff members that he/she decides to use in connection with the conduct of the Trial. The Institution assures that the performance of this separate agreement between Biogen and the Investigator will not constitute a violation of the Investigator’s duties nor a violation of the other Staff members’ duties. Zdravotnické zařízení pověří příslušně kvalifikovaného zaměstnance a člena Personálu v pozici farmaceuta k zajištění řádného zacházení a následného výdeje Produktu dle požadavků Zkoušejícího, v souladu se Správnou lékárenskou praxí (vyhláška č. 84/2008 Sb.), Platnými zákony a předpisy a ustanoveními Protokolu. The Institution will authorize an employee and member of the Staff appropriately qualified to act as the pharmacist to secure proper handling and subsequent distribution of the Product as requested by the Investigator, and in accordance with Good Pharmacy Practice (Regulation No. 84/2008 Coll.), Applicable Laws and Regulations and the provisions of the Protocol.
Participating Staff. The Study shall be conducted under the immediate direction of the Investigator. Institution and Investigator shall ensure that all Staff personally perform their assigned Study tasks, as indicated in the Protocol and in accordance with this Agreement. Investigator shall qualify such personnel and oversee their work. Investigator may have one or more sub-investigator(s) work on the Study; provided, however, that Investigator is responsible for all work conducted by sub-investigator. Any such sub-investigator shall be subject to all of the terms and conditions of this Agreement, including all obligations of Investigator. No sub-investigator may work on the Study unless he or she is qualified through experience and training to conduct clinical studies and agrees to be involved through completion of the Study. The sub-investigator’s name shall appear in the appropriate space on the FDA Form 1572 or Investigator Agreement for medical device studies. Notwithstanding the foregoing, Sponsor may disapprove any proposed sub-investigator within five (5) days of submission of FDA Form 1572 or Investigator Agreement for medical device studies. For purposes of this Agreement, “Staff” shall mean all Institution personnel including, but not limited to, researchers, investigators, sub-investigators, study coordinators, professional staff, and any other person performing research and/or services related to the Study on behalf of Institution, or to whom Institution provides access to Study materials or study drug (“Study Drug”).
Participating Staff. The InstitutionFoundation shall choose the Investigator on its own responsibility. The InstitutionFoundation hereby declares that the Investigator has undergone the necessary training and has the required experience and means for conducting the Trial. The InstitutionFoundation shall guarantee that this Agreement will be duly performed by the Investigator chosen on its responsibility. The InstitutionFoundation shall not be able to replace the Investigator with another Investigator without the prior written consent of Biogen. The InstitutionFoundation shall provide, and shall cause the Investigator to provide, Biogen and its representatives with information regarding the staff participating in the Trial (the Staff). For the avoidance of doubt the Staff shall throughout the term of this Agreement be under the supervision and control of the InstitutionFoundation and the Investigator, and the InstitutionFoundation and Investigator shall without limitation be responsible for ensuring that the Staff act in accordance with the Applicable Laws and Regulations and, Biogen’s and its representatives’ reasonable instructions. (b)
Participating Staff. The Investigator declares to have undergone the necessary training and has the required experience and means for conducting the Trial. The Institution shall supervise that the Trial will be duly performed by the Investigator in accordance with this Agreement. The Institution shall not be able to replace the Investigator with another investigator without the prior written consent of Biogen. The Investigator shall provideBiogen and its representatives with information regarding the other staff participating in the Trial (the Investigator and the other staff collectively referred to as the “Staff”). For the avoidance of doubt, the Staff shall throughout the term of this Agreement be under the supervision and control of the Institution, and the Institution shall be responsible for ensuring that the Staff act in accordance with the Applicable Laws and Regulations and, Biogen’s and its representatives’ reasonable instructions. The Institution acknowledges and agrees that the Investigator enters into a separate agreement with Biogen and the CRO under which he/she will receive direct payment from the CRO for the services performed by the Investigator in connection with the Trial and by the other Staff members. The Investigator shall be responsible for the compensation of any Staff members that he/she decides to use in connection with the conduct of the Trial. The Institution assures that the performance of this separate agreement between Biogen and the Investigator will not constitute a violation of the Investigator’s duties nor a violation of the other Staff members’ duties toward Institution.
