Study Personnel Sample Clauses
The Study Personnel clause defines the requirements and responsibilities related to individuals involved in conducting a study under an agreement. It typically specifies qualifications, training, and roles of staff such as principal investigators, research coordinators, and other team members, and may require prior approval or notification for personnel changes. This clause ensures that only appropriately qualified and authorized individuals participate in the study, thereby maintaining the integrity of the research and compliance with regulatory or sponsor requirements.
Study Personnel. Site and Training of 3. Poskytovatel a proškolení personálu.
A. The Study Site represents and warrants that the Principal Investigator is an employee of Study Site. Study Site shall ensure that the Principal Investigator and all other employees and agents of the Study Site who perform services under this Agreement (i) have the necessary experience, qualifications and training to perform such services, including implementing the Protocol, and dispensing and administering the Study Drug safely and effectively, (ii) are aware of the obligations contained in this Agreement that pertain to Study Site and their respective responsibilities, and (iii) shall initiate, conduct and complete in a diligent manner each step of the Study for which they are responsible. The Study Site shall not outsource, subcontract or delegate any of its obligations hereunder to a third party without the prior written consent of DSI. A. Poskytovatel prohlašuje a zaručuje, že hlavní zkoušející je zaměstnancem poskytovatele. Poskytovatel musí zajistit, že hlavní zkoušející a všichni další zaměstnanci a zástupci poskytovatele, kteří budou provádět služby podle této smlouvy, (i) ▇▇▇▇ potřebné zkušenosti, kvalifikaci a školení k provádění těchto služeb, včetně provádění protokolu a výdeje a podávání hodnoceného léku bezpečným a účinným způsobem, (ii) jsou si vědomi závazků obsažených v této smlouvě, které se týkají poskytovatele a jejich příslušných povinností, a (iii) řádným způsobem zahájí, budou provádět a dokončí každý ▇▇▇▇ této studie, za který zodpovídají. Poskytovatel nesmí své závazky podle této smlouvy bez předchozího písemného souhlasu DSI řešit zadáním subdodavatelské zakázky nebo subdodávky ani pověřením.
B. The Study Site will notify DSI and DSI’s designee Quintiles Czech Republic, s.r.o. (“CRO”) promptly by telephone and subsequently in writing, of any significant changes in Study Site personnel, Principal Investigator, or physical location that occur during the Study, including, without limitation any change in the Principal Investigator’s employment by Study Site. B. Poskytovatel oznámí společnosti DSI a zástupci DSI, společnosti Quintiles Czech Republic, s.r.o. (▇▇▇▇ ▇▇▇ „CRO“), ihned telefonicky a následně písemně všechny významné změny týmu pracovníků poskytovatele, osoby hlavního zkoušejícího nebo fyzického umístění, ke kterým dojde v průběhu studie, mimo jiné včetně jakékoli změny zaměstnaneckého poměru hlavního zkoušejícího u poskytovatele.
Study Personnel. Professional, clerical and other personnel necessary for the effective completion of the Study (collectively, “Study Personnel”) shall at all times be employed or contracted by the Recipient to perform the Study in accordance with the Grant Proposal. The Recipient shall ensure all Study Personnel comply with the terms and conditions of this Agreement. The Recipient shall promptly notify the Foundation in advance of any changes in key Study Personnel, including the Fellow, Mentor, co-investigators and any collaborating investigators from other Recipients, as identified in the Grant Proposal. Any key Study Personnel changes not approved in advance and in writing by the Foundation may result in termination of this Agreement in accordance with Section 14a and forfeiture of any future installments of the Grant Amount under this Agreement.
Study Personnel. Institution will arrange for qualified medical, technical, laboratory, clerical and other personnel, including Sub-investigators and permitted subcontractors pursuant to Section 10.6, if applicable, that are necessary, desirable, and available to support and carry out Institution’s obligations under this Agreement (collectively, the “Study Personnel”). Institution will be solely responsible for paying Study Personnel. Further, Institution will ensure that before commencing any work on the Study, all Study Personnel are subject to written obligations to Institution under which they (a) are bound to obligations of confidentiality and non-use with respect to Confidential Information (as defined in Section 5) that are consistent with the terms of this Agreement; and (b) assign and otherwise effectively vest in Institution any and all rights that such Study Personnel might otherwise have in the results of their work without any obligation of Sponsor to pay any royalties or other consideration to such Study Personnel.
Study Personnel. Upon the prior written consent of SPONSOR, INSTITUTION may use other employees of INSTITUTION and contractors, including the personnel of any Study facility named in PRINCIPAL INVESTIGATOR’s FDA Form 1575, to perform any Study-related services under this Agreement (together with PRINCIPAL INVESTIGATOR, “Study Personnel”). INSTITUTION shall ensure that:
(i) Adequate numbers of qualified Study Personnel are assigned to the Studies to meet its obligations under this Agreement;
(ii) All Study Personnel perform their Study responsibilities and fulfill their obligations under this Agreement;
(iii) All Study Personnel have the necessary licenses and certifications as may be required to perform their Study responsibilities, and shall, upon request of SPONSOR, provide such documented evidence of any such licenses and certifications;
(iv) All Study Personnel receive the necessary information, education, and training in any applicable regulatory requirements, proper performance of the Protocols, GCP Guidelines, and any other applicable guidelines relevant to the Studies and performance of the Protocols, and shall, upon request of SPONSOR, provide such documented evidence of any such education and training; and
(v) Any Study Personnel not employed by INSTITUTION shall comply with the same terms to those Study Personnel employeed by the INSTITUTIONhereunder.
Study Personnel. THM shall ensure that all Study Personnel shall: (i) have the appropriate experience and qualifications to participate in and perform the Study pursuant to the Research Program; and (ii) comply with the terms and conditions set forth in this Agreement.
Study Personnel. Study Personnel shall include any individual by way of example, engaged by Institution, Participating Site and/or Investigator who (a) participates in the conduct of the Study; (b) is privy to information related to the scientific elements of this Study that have the potential to give rise to any Inventions (defined in Section 13.2 below) or rights related to such Inventions; and/or (c) is privy to any other Confidential Information (defined below) and such other individuals set forth in the Study proposal and Study budget provided to GSK and/or LIXTE (“Study Personnel”). For avoidance of doubt, Sub-investigator(s) (as defined in Section 7.4 below) is/are Study Personnel.
Study Personnel. Site represents that, during the course of the Study, all subinvestigators, employees, contractors, affiliates, agents and any other persons performing services for the Study (together as “Personnel”) shall have the appropriate training, information, licenses, approvals, and certifications necessary to safely, adequately and lawfully perform the Study in accordance with this Agreement. Further, Site shall be responsible to ensure that the Personnel 1.3 Pracovníci provádějící studii: Místo výkonu klinického hodnocení prohlašuje, že po celou dobu provádění Studie všichni spoluzkoušející, zaměstnanci, dodavatelé, pobočky, zástupci a jakékoli jiné osoby, které budou poskytovat služby pro účely studie (společně jen jako „Pracovníci“), budou mít řádnou kvalifikaci, informace, oprávnění, souhlasy a certifikace potřebné k bezpečnému, řádnému a zákonnému provádění studie v souladu s touto Smlouvou. have read and understood the Protocol and shall perform their activities and fulfill their obligations in a timely and competent manner. Dále musí Místo výkonu klinického hodnocení zajistit, aby si pracovníci přečetli protokol, chápali jeho obsah a vykonávali svou činnost a plnili své povinnosti včas a správným způsobem.
Study Personnel. 6.1.1 [***]
6.1.2 [***]
Study Personnel. Site represents that, during the course of the Study, all subinvestigators, employees, contractors, affiliates, agents and any other persons performing services for the Study (together as “Personnel”) shall have the 1.3 Pracovníci provádějící studii: Místo výkonu klinického hodnocení prohlašuje, že po celou dobu provádění Studie všichni spoluzkoušející, zaměstnanci, dodavatelé, pobočky, zástupci a jakékoli jiné osoby, které budou poskytovat appropriate training, information, licenses, approvals, and certifications necessary to safely, adequately and lawfully perform the Study in accordance with this Agreement. Further, the Investigator and Institution will ensure that the personnel have read and understood the protocol and shall perform their activities and fulfill their obligations in a timely and competent manner. služby pro účely Studie (společně jen jako „Pracovníci“), budou mít řádnou kvalifikaci, informace, oprávnění, souhlasy a certifikace potřebné k bezpečnému, řádnému a zákonnému provádění Studie v souladu s touto Smlouvou. Dále Zkoušející a Instituce zajistí, aby si Pracovníci přečetli Protokol, chápali jeho obsah a vykonávali svou činnost a plnili své povinnosti včas a správným způsobem.
Study Personnel. (a) USOR shall cause each Investigator to complete, sign and deliver to BIND or its designee FDA Form 1572 prior to commencement of the Study at any such Investigator’s Site. In the event an Investigator becomes unwilling or unable to perform the duties required by this Agreement and the Protocol, USOR shall reasonably cooperate with BIND to find a replacement; provided, however, that such Investigator shall continue to be bound by the surviving provisions of this Agreement set forth in Section 16.6 applicable to him/her. If an acceptable replacement is not found within thirty (30) days, BIND may terminate the Study at such Investigator’s Site.
(b) Subject to the terms and conditions of this Section 2.3, USOR shall be responsible for determining the division of obligations and responsibilities between USOR, Sites and Investigators with respect to providing services under this Agreement. USOR represents and warrants that it has the lawful authority to bind the Sites to the terms and conditions of this Agreement in connection with their respective performance of the Study on behalf of BIND and USOR, such that the performance of services hereunder at Study Facility(ies) by Study Personnel does not prejudice the rights of BIND hereunder. USOR shall cause each of Site’s obligations and responsibilities under this Agreement to apply to the Site in all relevant respects.
(c) USOR shall cause the Investigator to (i) exercise independent medical judgment as to the compatibility of each Subject with the Protocol requirements, (ii) notify BIND of any deviations from the Protocol and (iii) notify BIND of any unanticipated or serious adverse reactions to the Investigational New Drug.