Study Protocol Clause Samples

Study Protocol. Author Manuscript

Study Protocol. A.The Site will conduct the study entitled “xxxxxxxxxxxx xxxxxxxx xxxxxxxxxxxx xxxxxxxxxxxxxxxxx xxxxxxxxxxxx xxxxxxxxxx” (the “Study”) at workplace of the Institution: department of internal medicine, Orlickoustrecka hospital, Cs. Armady 1076, 562 18 Usti nad Labem, in strict accordance with the Protocol, incorporated herein by reference, as may be further amended pursuant to the terms of this Agreement (the “Protocol”). The Protocol sets forth the clinical research activities and responsibilities to be undertaken, pursued, and followed with all due diligence by the Site. The Protocol shall be considered final after it is signed by ▇▇▇▇▇▇▇ and the Investigator and approved by the relevant regulatory authority (“RA”) and Ethics Committee (“EC”). Thereafter, the Protocol may be amended only by prior written consent of Sponsor and subsequent approval by the RA/EC. The Parties agree that in the event of a conflict between the terms of the Protocol and the terms of this Agreement, the terms of this Agreement shall govern, except in the case of matters relating directly to clinical procedures or patient safety, with respect to which the terms of the Protocol shall prevail. A. Aniž by bylo dotčeno předchozí, Smluvní strany berou na vědomí a souhlasí, že pokud Zkoušející určí podle svého nejlepšího lékařského posouzení, že kvůli eliminaci zjevného bezprostředního rizika pro zdraví nebo bezpečnosti jakéhokoli subjektu účastnícího se Klinického hodnocení je nutná odchylka od Protokolu, může se odchýlit od Protokolu; Zkoušející však bude (i) po celou dobu jednat v souladu s obecně přijatými standardy klinického hodnocení a lékařské praxe a veškerými příslušnými federálními, státními nebo místními zákony a právními předpisy, a (ii) okamžitě písemně oznámí Zadavateli B. Notwithstanding the foregoing, the Parties acknowledge and agree that if the Investigator determines in his/her best medical judgment that a deviation from the Protocol is necessary to eliminate an apparent immediate hazard to the health or safety of any subject participating in the Study, he or she may deviate from the Protocol; provided, however, that the Investigator shall (i) at all times act in accordance with generally accepted standards of clinical study and medical practice and any and all applicable federal, state, or local laws and regulations, and (ii) immediately notify Sponsor in writing of the facts giving rise to the need for skutečnosti, které vedly k nutnosti odchýlení se, a jakými odl...

Study Protocol. Upon acceptance of this individual project agreement, a study protocol will be developed to specify the methods to be used, batching of samples, pathology scoring, reporting of results and other relevant study details. This study protocol shall be submitted to Clovis for acceptance prior to receipt and analysis of any specimens.

Study Protocol. Each of the Evaluation Studies conducted by ▇▇▇▇▇▇ will be conducted pursuant to the Study Protocol Synopsis as set forth in the respective Device Order Avalyn is responsible for the proper design of the associated Study Protocol.

Study Protocol. Institution will conduct the Study in accordance with “***” and any, subsequent amendments thereto, incorporated by reference herein (the “Protocol”). The Protocol fully details the clinical research activities and responsibilities to be undertaken, pursued, and followed with all due diligence, by Institution. The Protocol will be considered final after it is approved by the Institution’s Institutional Review Board or another designated Institutional Review Board (“IRB”). Institution will provide AIM with the final Protocol, which shall be considered Confidential Information pursuant to section 8 of this Agreement before commencement of the Study. Thereafter, the Protocol may be amended only following consultation with AIM and consent of the Institution and subsequent approval by the IRB.

Study Protocol. In conducting and participating in the Study, Clinician Site and the Investigator shall comply with all applicable laws on data collection procedures and reimbursement procedures, protection of the personal data and moral rights of patients, especially including the secrecy of medical documentation archives and maintenance of records, as well as all other terms, conditions and obligations for clinician sites and investigators, including but not limited to follow the serious adverse event reporting process, as outlined in the Study protocol number RFB002A2406, attached hereto as Exhibit A, and any amendment thereof (the “Study Protocol”). In the event that the Study Protocol and this Agreement conflict, the Study Protocol shall prevail. 1.

Study Protocol. The Protocol is final when it is executed by both Sponsor and Principal Investigator and approved by the relevant competent ethics committee and/or internal review board (“Ethics Committee”) and the State Institute for Drug Control (“ŠÚKL”), as may be applicable.

Study Protocol. Institution and Investigator may not reassign the conduct of the Study to a different investigator without prior written authorization from Sponsor. Any replacement Investigator will be required to agree to the terms and conditions of this Agreement in a separate writing. In the event CRO or Sponsor does not approve a replacement Investigator, CRO or Sponsor may terminate this Agreement in accordance with the termination provisions below. Sponsor shall obtain approval from the governing Ethics Committee(s) (the “EC(s)’) for the Protocol and the informed consent form before initiation of the Study. If the approval is not obtained, this Agreement shall be null and void. Sponsor or CRO will provide Institution with a copy of each such approval. In addition, Sponsor will coordinate with the EC to obtain review and approval in writing of any amendments made to the Protocol or ICF (as defined below). The Parties acknowledge and agree that no change to the Protocol, ICF, or any other Study-related document shall be made without the prior written consent of Sponsor and CRO. Any change to the Protocol or any other Study document that is agreed upon in writing by Sponsor and CRO is incorporated into this Agreement by this reference. Protokol Studie. Poskytovatel zdravotních služeb a Zkoušející nesmí pověřit provedením Studie jiného zkoušejícího bez předchozího písemného svolení od Zadavatele. Jakýkoli náhradní Zkoušející bude muset souhlasit s podmínkami této Smlouvy v samostatné písemné formě. V případě, že CRO nebo Zadavatel neschválí náhradního Zkoušejícího, může CRO nebo Zadavatel ukončit tuto Smlouvu v souladu s ustanoveními o ukončení uvedenými níže. Zadavatel získá schválení z příslušné(-ých) etické(-ých) komise(-í) (dále jen „EK“) pro Protokol a informovaný souhlas před zahájením Studie. Pokud nebude získáno schválení, tato Smlouva bude zneplatněna a anulována. Zadavatel nebo CRO poskytne Poskytovateli zdravotních služeb kopii každého takového schválení. Kromě toho Zadavatel bude koordinovat s EK kroky pro získání a písemné schválení jakýchkoli dodatků provedených v Protokolu nebo Formuláři informovaného souhlasu (definované níže). Smluvní strany potvrzují a souhlasí, že nebude provedena žádná změna Protokolu, Formuláře informovaného souhlasu nebo jiného dokumentu souvisejícího se Studií bez předchozího písemného souhlasu Zadavatele a CRO. Jakákoli změna Protokolu nebo jakéhokoli jiného dokumentu Studie, která je odsouhlasena písemně Zadavatelem a CRO, je so...

Study Protocol. Sponsor and/or CRO shall obtain approval from the Regulatory Authority (RA) and Ethics Committees (EC) per local law for the protocol identified above (“Protocol”) and the informed consent form before initiation of the Study. If the approval is not obtained, this Agreement shall be null and void. In addition, Sponsor and/or CRO will coordinate with the ECs to obtain review and approval in writing of any amendments made to the Protocol or ICF (as defined in Section 1.6 below). Any change to the Protocol or any other Study document that is agreed upon in writing by Sponsor and/or CRO is incorporated into this Agreement by this reference. 1.2 Protocol Deviation/Prompt Notice. Deviations from the Protocol are not permitted except when necessary to protect the safety, rights or welfare of subjects enrolled in the Study. Institution is obliged to ensure that Investigator will, within one (1) business day from occurrence, or as specified in the Protocol, notify Sponsor of any (a) deviation from the Protocol, including any deviations necessary to protect the safety, rights or welfare of subjects enrolled in the Study, (b) serious adverse event (as defined in the Protocol) which occurs to a subject in the Study or (c) communication with a regulatory agency concerning (i) the Study, including any requests to inspect, examine, copy or remove records of the Study, (ii) another study which might have an impact on the Study or (iii) the qualification of Institution or Investigator to perform the Study. In addition, Institution is obliged to ensure that 1.