Study Protocol Clause Samples

Study Protocol. Author Manuscript

Study Protocol. CRO shall prepare Study Protocol according to the latest version of the template of CRO or SPONSOR and any additional requirement from SPONSOR for SPONSOR's review and approval on the date of signing the SOW and provide Study Protocol to SPONSOR within thirty (30) days after the effective date of this Agreement. The Protocol will specify the Study design, objectives, inclusion and exclusion criteria, procedures for reporting adverse events, statistical analysis and other relevant issues. All changes, alterations and/or modifications in the Protocol shall be signed by both CRO and SPONSOR and shall be deemed incorporated into the Protocol. In addition, if, pursuant to the applicable policies/regulations of the Institutional Review Board/Independent Ethics Committee (IRB/IEC), any changes, alterations and/or modifications to the Protocol require the approval of the IRB/IEC, then CRO shall promptly obtain such approval. SPONSOR shall have the right at any time and from time to time to initiate changes, alterations and/or modifications to the Protocol as SPONSOR may deem necessary or appropriate, including, without limitation, suspending the Study temporarily or permanently. CRO is responsible for the application for IRB/IEC approval, including preparation and submission of the requested documents, communication with corresponding authority and obtaining approval as per the applicable policies/regulations. SPONSOR shall assist CRO to obtain this approval. CRO shall conduct the Study in compliance with the approved Protocol by IRB/IEC, and shall obey to any requirement and perform required adjustment by the IRB/IEC if any non-compliance occurred before/during the conduct of the Study. CRO shall delegate personnel on behalf of SPONSOR if requested and provide the relevant information (e.g. membership lists, meeting minutes, correspondence, etc) asked by SPONSOR or regulatory authorities in case of need. CRO shall prepare the Written Informed Consent forms (if applicable) both in English and local language (if applicable) according to the latest version of the template of CRO and provide the SPONSOR with such forms for its review and approval. CRO shall not enroll any subject in a Study unless and until it has received and certified the same in writing to SPONSOR documentation evidencing that the IRB/IEC has reviewed and approved the Protocol and the Informed Consent Form. CRO shall ensure that all subjects are in compliance with all of the Protocol requirements....

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. 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. 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. A. The Site will conduct the study entitled “xxxxxxxxxx xxxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxxxxxx xxxxxxxxxxxxxx xxxxxxxxxxxxxx xxxxxxxxxxxxxxxx xxxxxxxxx” (the “Study”) at Institution 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. B. 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

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 (“SÚKL”).

Study Protocol. Institution 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. Institution shall obtain approval from the governing Ethics Committee(s) (the “ECs’) 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. Institution will provide CRO with a copy of each such approval, together with all relevant correspondence with the EC regarding such approval. In addition, Institution will coordinate with the EC to obtain review and approval in writing of any amendments made to the Protocol or ICF (as defined below). Institution will ensure that members of the EC are subject to obligations of confidentiality and non-use at least as protective of Sponsor and CRO as those that apply to Institution under this Agreement. 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. Zdravotnické zařízení 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. Zdravotnické zařízení 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. Zdravotnické zařízení poskytne CRO kopii každého takového schválení spolu s veškerou příslušnou korespondencí s EK ohledně takového schválení. Kromě toho bude Zdravotnické koordinovat s EK kroky pro získání a písemné schválení jakýchkoli dodatků provedených v Protokolu nebo Formuláři informovaného souhlasu (definované níže). Zdravotnické zařízení zajistí, ...

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...