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Studie Sample Clauses

Studie. Principal Investigator and Institution shall ensure that the Study to be performed under this Agreement shall be performed in strict accordance with the terms of the final protocol (as approved by the Parties and the applicable Ethics Committee (“EC”) and as it may be amended from time to time in accordance with the terms of this Agreement) (the “Protocol”) which is entitled “A Randomized, Multicenter, Open-Label, Phase 3 Study of Acalabrutinib (ACP-196) Versus Investigator’s Choice of Either Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in Subjects with Relapsed or Refractory Chronic Lymphocytic Leukemia” Protocol Number ACE-CL-309. A copy of the Protocol is attached hereto by reference as Exhibit B. The Institution and Principal Investigator acknowledge receipt of the Protocol. Hlavní zkoušející a zdravotnické zařízení zajistí, aby studie, která má být podle této smlouvy provedena, byla provedena v přísném souladu s podmínkami finálního protokolu (schváleného smluvními stranami a příslušnou etickou komisí (dále jen „EK“) a ve znění případných pozdějších dodatků a v souladu s podmínkami této smlouvy) (dále jen „protokol“) nazvaného „Randomizované multicentrické otevřené klinické hodnocení fáze 3 zkoumající acalabrutinib (ACP-196) v porovnání s léčbou zvolenou zkoušejícím, která zahrnuje buď idelalisib plus rituximab nebo bendamustin plus rituximab, u pacientů s relabující nebo refrakterní chronickou lymfatickou leukémií“ číslo protokolu ACE-CL-309. Kopie protokolu je připojena k této smlouvě odkazem jako příloha B. Zdravotnické zařízení a hlavní zkoušející potvrzují přijetí protokolu.
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Studie. The Parties agree to conduct the Study in accordance with the Protocol, any condition of the ethics committee reviewing the Study, and all laws, rules and regulations that apply to the Study’s conduct at the Study Site in the relevant jurisdiction.
Studie. (a) , II. Interní klinika (xxxx xxx „Zkoušející“) bude hlavním zkoušejícím Studie.
Studie. POSKYTOVATEL prostřednictvím ZKOUŠEJÍCÍHO provede Studii v souladu s Protokolem schváleným etickou komisí příslušnou pro Studii, ve znění pozdějších změn (xxxx xxx „Protokol“), a v souladu se správnou výzkumnou praxí. Vyžaduje-li to příslušné právo a/nebo Protokol, ZADAVATEL předloží Protokol k přezkumu a schválení – Státnímu ústavu pro kontrolu léčiv a nezávislé hodnotící komisi složené z vědců nebo jiných kvalifikovaných osob v souladu s Helsinskou deklarací se soudní příslušností nad prováděním studie
Studie. POSKYTOVATEL prostřednictvím ZKOUŠEJÍCÍHO provede Studii v souladu s Protokolem schváleným etickou komisí příslušnou pro Studii, ve znění pozdějších změn (xxxx xxx „Protokol“), a v souladu se správnou výzkumnou praxí. Vyžaduje-li to příslušné právno a/nebo Protokol, ZADAVATEL předloží Protokol k přezkumu a scvhálení Státnímu ústavu pro kontrolu léči a nezávislé hodnotící komisi složené z vědců nebo jiných kvalifikovaných osob v souladu s Helsinskou deklarací se soudní příslušností nad prováděním studie (jakákoliv taková komise, orgán nebo výbor xxxx xxx „IRB“). Změny Protokolu lze provést (i) postupy stanovenými v Protokolu, nebo (ii) písemnou dohodou POSKYTOVATELE a ZADAVATELE. Změny Protokolu musí být oznámeny, přezkoumány a/nebo schváleny IRB tak, jak to požaduje příslušné právo a/nebo Protokol.
Studie. (a) („Zkoušející“) bude hlavním zkoušejícím Studie. (b) Protokol je zde tímto začleněn formou odkazu a provádění Studie se xxx bude řídit. CRO bude mít na pokyn Zadavatele právo Protokol upravovat a/nebo doplňovat formou dodatků v souladu s veškerými právními předpisy a tyto úpravy a/nebo doplnění oznamovat Zdravotnickému zařízení a/nebo Zadavateli. (c) Zdravotnické zařízení bude Studii realizovat v místě Zdravotnického zařízení uvedeném na podpisové straně níže („Místo provádění klinického hodnocení”), a to tak, že bude činnosti a testy v rámci klinického hodnocení popsané v Protokolu, za něž odpovídá Zkoušející, provádět samo nebo zprostředkovaně. (d) Rozpočet, který zde tvoří Přílohu A a který je do této Smlouvy začleněn formou tohoto odkazu (xxxx xxx „Rozpočet“), stanoví všechny platby, které má CRO poukázat Zdravotnickému zařízení za realizaci Studie. (e) Zdravotnické zařízení a Zkoušející budou postupovat v souladu s podmínkami a požadavky stanovenými touto Smlouvou a v Protokolu. Zdravotnické zařízení ani Zkoušející nesmí provádět žádné změny této Smlouvy ani Protokolu, ani se od nich jakkoli odchylovat, pokud si k tomu neopatří předchozí písemný souhlas CRO. Ocitne-li se některá z podmínek této Smlouvy ohledně of the Study is in conflict with any term of the Protocol, the Protocol shall control.
Studie. Jedná se o neintervenční studii s názvem PROMETCO, která bude prováděna v souladu s protokolem. Zadavatel neposkytuje žádný výrobek ani jiné studijní léky. Poskytovateli a zkoušejícímu, proto mohou volit léčbu nebo péči, kterou považují za nejvhodnější pro své pacienty podle standardu péče.
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Related to Studie

  • Studies The clinical, pre-clinical and other studies and tests conducted by or on behalf of or sponsored by the Company or its subsidiaries that are described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus were and, if still pending, are being conducted in accordance in all material respects with all statutes, laws, rules and regulations, as applicable (including, without limitation, those administered by the FDA or by any foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA). The descriptions of the results of such studies and tests that are described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus are accurate and complete in all material respects and fairly present the published data derived from such studies and tests, and each of the Company and its subsidiaries has no knowledge of other studies or tests the results of which are materially inconsistent with or otherwise call into question the results described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus. Except as described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, neither the Company nor its subsidiaries has received any notices or other correspondence from the FDA or any other foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA with respect to any ongoing clinical or pre-clinical studies or tests requiring the termination or suspension of such studies or tests. For the avoidance of doubt, the Company makes no representation or warranty that the results of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company will be sufficient to obtain governmental approval from the FDA or any foreign, state or local governmental body exercising comparable authority.

  • Study An application for leave of absence for professional study must be supported by a written statement indicating what study or research is to be undertaken, or, if applicable, what subjects are to be studied and at what institutions.

  • Clinical 1.1 Provides comprehensive evidence based nursing care and individual case management to a specific group of patients/clients including assessment, intervention and evaluation. 1.2 Undertakes clinical shifts at the direction of senior staff and the Nursing Director including participation on the on-call/after-hours/weekend roster if required. 1.3 Responsible and accountable for patient safety and quality of care through planning, coordinating, performing, facilitating, and evaluating the delivery of patient care relating to a particular group of patients, clients or staff in the practice setting. 1.4 Monitors, reviews and reports upon the standard of nursing practice to ensure that colleagues are working within the scope of nursing practice, following appropriate clinical pathways, policies, procedures and adopting a risk management approach in patient care delivery. 1.5 Participates in xxxx rounds/case conferences as appropriate. 1.6 Educates patients/carers in post discharge management and organises discharge summaries/referrals to other services, as appropriate. 1.7 Supports and liaises with patients, carers, colleagues, medical, nursing, allied health, support staff, external agencies and the private sector to provide coordinated multidisciplinary care. 1.8 Completes clinical documentation and undertakes other administrative/management tasks as required. 1.9 Participates in departmental and other meetings as required to meet organisational and service objectives. 1.10 Develops and seeks to implement change utilising expert clinical knowledge through research and evidence based best practice. 1.11 Monitors and maintains availability of consumable stock. 1.12 Complies with and demonstrates a positive commitment to Regulations, Acts and Policies relevant to nursing including the Code of Ethics for Nurses in Australia, the Code of Conduct for Nurses in Australia, the National Competency Standards for the Registered Nurse and the Poisons Act 2014 and Medicines and Poisons Regulations 2016. 1.13 Promotes and participates in team building and decision making. 1.14 Responsible for the clinical supervision of nurses at Level 1 and/or Enrolled Nurses/ Assistants in Nursing under their supervision.

  • Trials The Ship shall run the following test and trials: (1) Harbour Acceptance Tests, including setting to work of the various equipment;

  • Clinical Studies The animal and other preclinical studies and clinical trials conducted by the Company or on behalf of the Company were, and, if still pending are, to the Company’s knowledge, being conducted in all material respects in compliance with all Applicable Laws and in accordance with experimental protocols, procedures and controls generally used by qualified experts in the preclinical study and clinical trials of new drugs and biologics as applied to comparable products to those being developed by the Company; the descriptions of the results of such preclinical studies and clinical trials contained in the Registration Statement and the Prospectus are accurate and complete in all material respects, and, except as set forth in the Registration Statement and the Prospectus, the Company has no knowledge of any other clinical trials or preclinical studies, the results of which reasonably call into question the clinical trial or preclinical study results described or referred to in the Registration Statement and the Prospectus when viewed in the context in which such results are described; and the Company has not received any written notices or correspondence from the FDA, the EMA, or any other domestic or foreign governmental agency requiring the termination, suspension or modification of any preclinical studies or clinical trials conducted by or on behalf of the Company that are described in the Registration Statement and the Prospectus or the results of which are referred to in the Registration Statement and the Prospectus.

  • Clinical Trials The studies, tests and preclinical and clinical trials conducted by or on behalf of, or sponsored by, the Company, or in which the Company has participated, that are described in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, were and, if still pending, are being conducted in all material respects in accordance with protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company and all applicable statutes, rules and regulations of the FDA, the EMEA, Health Canada and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States to which they are subject; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleading; the Company has no knowledge of any studies, tests or trials not described in the Disclosure Package and the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Registration Statement, the Time of Sale Disclosure Package or Prospectus; and the Company has not received any notices or other correspondence from the FDA, EMEA, Health Canada or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus, there has not been any violation of law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action.

  • Investigator Where a difference arises between the parties relating to the dismissal, discipline or suspension of an employee, or to the interpretation, application, operation or alleged violation of this agreement, including any questions as to whether a matter is arbitrable, during the term of the collective agreement, an arbitrator agreed to by the parties shall, at the request of either party: (a) investigate the difference; (b) define the issue in the difference; and (c) make written recommendations to resolve the difference within five days of the date of receipt of the request and for those five days from that date time does not run in respect of the grievance procedure. The parties agree that this procedure will not be invoked until the grievance procedure has been completed.

  • Study Population ‌ Infants who underwent creation of an enterostomy receiving postoperative care and awaiting enterostomy closure: to be assessed for eligibility: n = 201 to be assigned to the study: n = 106 to be analysed: n = 106 Duration of intervention per patient of the intervention group: 6 weeks between enterostomy creation and enterostomy closure Follow-up per patient: 3 months, 6 months and 12 months post enterostomy closure, following enterostomy closure (12-month follow-up only applicable for patients that are recruited early enough to complete this follow-up within the 48 month of overall study duration).

  • Research Analyst Independence The Company acknowledges that the Underwriters’ research analysts and research departments are required to be independent from their respective investment banking divisions and are subject to certain regulations and internal policies, and that such Underwriters’ research analysts may hold views and make statements or investment recommendations and/or publish research reports with respect to the Company and/or the offering that differ from the views of their respective investment banking divisions. The Company hereby waives and releases, to the fullest extent permitted by law, any claims that the Company may have against the Underwriters with respect to any conflict of interest that may arise from the fact that the views expressed by their independent research analysts and research departments may be different from or inconsistent with the views or advice communicated to the Company by such Underwriters’ investment banking divisions. The Company acknowledges that each of the Underwriters is a full service securities firm and as such from time to time, subject to applicable securities laws, may effect transactions for its own account or the account of its customers and hold long or short positions in debt or equity securities of the companies that may be the subject of the transactions contemplated by this Agreement.

  • Investigatory Interviews ‌ A. Upon request, an employee has the right to a union representative at an investigatory interview called by the Employer, if the employee reasonably believes discipline could result. An employee may also have a union representative at a pre-disciplinary meeting. If the requested representative is not reasonably available, the employee will select another representative who is available. Employees seeking representation are responsible for contacting their representative.

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