Study Protocol. Author Manuscript
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. 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. EXPLANATORY NOTE: [***] INDICATES THE PORTION OF THIS EXHIBIT THAT HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND
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. 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. 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 Xxxxxxx 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.
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. 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.
Study Protocol. Note 1: The Protocol must set out the objectives, design, methodology, statistical and organisational arrangements. Guidance on information that should be included in the Protocol is available from the HRA website: xxx.xxx.xxx.xx Note 2: The Parties should check that there are no conflicts between Agreement clauses and Protocol. Any conflicts that are identified must be resolved prior to signing this Agreement. Note 3: Should there be any inconsistency between the Protocol and the other terms of this Agreement, or any document incorporated therein, clause 16.1 of this Agreement shall apply. Summary of Governance Arrangements [Insert details cash and in-kind support]Funder(s)………………….[Insert NAME and ADDRESS] Sponsor(s)……………… .[Insert NAME and ADDRESS] (State if co-sponsorship or joint sponsorship) Chief Investigator for the Study….[Insert NAME and ADDRESS]………….Substantive Employer….[Insert NAME and ADDRESS]………………. Principal Investigator….[Insert NAME and ADDRESS]……… Substantive Employer ……….[Insert NAME and ADDRESS]…………. NHS Other If not substantively employed by Participating Site, XX holds honorary/clinical academic contract Yes Study coordinating organisation……….[Insert NAME and ADDRESS]…………………. Other organisations (specify) Sponsor Service Providers (for use when outsourcing directly impacts on Participating Site – e.g. use of a CRO, CTU, etc.) ….[Insert NAME and ADDRESS] NHS Organisation SubContractors of Protocol-related activities which are not part of standard NHS care ….[Insert NAME and ADDRESS] Estimated number of Participants to be recruited at the Site ………….[Insert NUMBER, AS APPROPRIATE]………… [Insert PROTOCOL Version [insert] Dated [insert] provided separately] SCHEDULE 2 Trial Conduct at the Participating Site DIVISION OF RESPONSIBILITIES AND DELEGATION OF ACTIVITIES (Although some RESPONSIBILITIES cannot be delegated this schedule does allow delegation of ACTIVITIES – e.g. to an Investigator, CTU or CRO – to be detailed) The Parties collaborating in the Study will undertake responsibilities as attributed in the table below. Note 1: Parties should set out any agreed delegation of ACTIVITIES in the table below. Note 2: Where there is more than one Sponsor, the name of the Sponsor responsible for each activity should be entered for the activity. Note 3: Some responsibilities are only applicable to particular types of study. Where a particular activity is not applicable to the Study N/A should be entered for the activity.
Study Protocol. INSTITUTION and Principal Investigator agree to perform the Clinical Trial in accordance with the Protocol, which may be amended from time-to-time by SPONSOR with prior Institutional Review Board ("IRB") approval; provided, however, that the INSTITUTION and Principal Investigator may deviate from the Protocol only when necessary (and with prompt notice to SPONSOR) to protect the safety, rights or welfare of Trial Subjects (as hereinafter defined). The parties agree that in the event of a conflict between the Protocol and this Agreement, the terms of this Agreement shall govern, except in the case of matters relating directly to the scientific conduct of the Clinical Trial, with respect to which the terms of the Protocol shall prevail.
