Participating Staff Clause Samples
The Participating Staff clause defines which employees or personnel are authorized to be involved in the performance of services under the agreement. It typically lists specific individuals or roles, and may require the consent of both parties for any substitutions or changes to the assigned staff. This clause ensures that the parties have clarity and control over who is delivering the contracted work, thereby maintaining quality and consistency throughout the engagement.
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) ▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇. ▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇, ▇▇ 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 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.
(c) Zahájení Klinického hodnocení. Zdravotnické zařízení a Zkoušející se zavazují, že nezahájí výběr potenciálních Subjektů k účasti (c)
Participating Staff. The Study shall be conducted under the immediate direction of the Investigator. Institution shall ensure that all Study Staff, including Investigator, personally perform their assigned Study tasks, as indicated in the Protocol and in accordance with this Agreement. Investigator shall qualify such personnel and oversee the work of other Study Staff. 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. Notwithstanding the foregoing, Sponsor may disapprove any proposed sub-investigator within five (5) days of submission of FDA Form 1572. For purposes of this Agreement, “Staff” shall mean all Institution personnel including, but not limited to, faculty, researchers, investigators, sub-investigators, study coordinators and any other person performing services related to the Study on behalf of Institution, or to whom Institution provides access to Study materials or study drug (“Study Drug”). < Institution> CTA
Participating Staff. Biogen 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, skills, knowledge and facilities 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 Investigator shall 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. 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 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. Agreements shall be concluded between Biogen and each respective Staff member, including but not limited to the Investigator, which shall stipulate terms and conditions of remuneration for each Staff member. Members of the Staff shall be solely responsible for due taxation of their income. 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 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 a předpisy a ustanoveními Protokolu. of the Protocol.
Participating Staff. The Institution and Investigator hereby declare that the Investigator has undergone the necessary training and has the required experience and means for conducting the Trial. The Institution shall guarantee that this Agreement will be duly performed by the Investigator chosen on its responsibility. 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 Institution and the Investigator, and the Institution and Investigator shall be responsible for ensuring to the extent there is no negligence or willful misconduct of the Staff that the Staff act in accordance with the Applicable Laws and Regulations and, Biogen’s and its representatives’ reasonable instructions. 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 Institution represents that the Principal Investigator has undergone the necessary training and has the required qualifications, experience and means for conducting the Trial. The Institution shall guarantee that this Agreement will be duly performed by the Principal Investigator. The Institution shall not be able to replace the Principal Investigator with another Principal Investigator without the prior written consent of X4. In the temporary absence of the Principal Investigator, the Institution shall assign Principal Investigator’s responsibilities hereunder to a qualified sub-investigator. If the Principal Investigator’s absence is anticipated to exceed seven (7) days or to be permanent, the Principal Investigator or the Institution shall inform X4 and CRO in writing, designate a sub- investigator to assume his/her responsibilities hereunder (subject to the written approval of X4) and shall provide reasonable assistance in finding a replacement acceptable to X4. The Institution acknowledges that in the event there is no sub-investigator to assume the responsibilities of the Principal Investigator, X4 shall make no payments to the Institution while the search for a replacement Principal Investigator is underway and agrees that it shall not enrol any additional Trial Subjects, nor continue ongoing visits in the absence of a designated Principal Investigator. If a replacement is unable to be found within thirty (30) days after notification, X4 may terminate this Agreement in accordance with Section 10 of this Agreement. If the Principal Investigator ceases to be affiliated with the Institution, and a replacement Principal Investigator cannot be found, X4 shall have the right to transfer the conduct of the Trial from the Institution to the Principal Investigator’s new institution/practice, požadavcích týkajících se IT vybavení, které nejsou uvedeny v tomto dokumentu nebo v protokolu, mu nemusí být ze strany Poskytovatele vyhověno. Nicméně Poskytovatel zaručuje, že takové případné budoucí požadavky Společnosti X4 neodmítne bez závažného důvodu spočívajícího v ohrožení kybernetické bezpečnosti.
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. Institution agrees to allow Principal Investigator and other Study Personnel to conduct the Study at Institution. The Institution shall choose the Principal 3. Povinnosti zdravotnického zařízení (a) Dodržování právních norem. Zdravotnické zařízení prohlašuje, že splňuje všechny zákonné požadavky ohledně provádění klinického hodnocení, a že získalo nebo že získá veškerá nezbytná povolení. Zdravotnické zařízení zaručuje, že uzavření a plnění této smlouvy bude probíhat v souladu s platnými zákony a interními předpisy zdravotnického zařízení. Zdravotnické zařízení ručí za to, že plněním této smlouvy nedojde k porušení pracovních povinností hlavního zkoušejícího.
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.