Ethics Committee Approval. Rigel shall obtain the written approval of the IEC before commencing the Study and shall provide CRO with the IEC’s letter of approval and a list of all IEC meeting attendees. Investigator and Institution shall each comply with any conditions of approval the IEC imposes. Institution shall provide the IEC with any required reports and updates and shall provide CRO with copies of all documents provided to or received from the IEC.
Ethics Committee Approval. The Recipient and the (ii) as provided for by law. Recipient’s Project Leader acknowledge that the Research Project has to be reviewed and approved by the Ethics Committee in charge, as further described in the Project Agreement.
Ethics Committee Approval. Prior to beginning the Study, Sponsor shall provide to Provider documentation verifying approval by the EC of the Protocol and the information to be provided to potential subjects of the Study to secure their informed consent. Sponsor shall promptly notify Provider and Principal investigator if the EC takes, or gives notice of its intent to take, any action that could reasonably be expected to affect the monitorovacího procesu nebo výsledků výzkumu, u nichž lze přiměřeně předpokládat, že (i) by mohly mít vliv na bezpečnost nebo lékařskou péči subjektů či jejich ochotu se dále účastnit klinického hodnocení; (ii) významně ovlivní realizaci klinického hodnocení, nebo (iii) povedou ke změně souhlasu EK s pokračováním klinického hodnocení.
Ethics Committee Approval. The study was carried out with the permission of University Clinical Research Ethics Committee (Date: 2022, Decision No: 2022/1937).
Ethics Committee Approval. This study was approved by institutional Review Board of İzmir Xxxxx Xxxxxx University (Non-Interventional Clinical Studies, 12.05.2020, 651). Informed Consent: Due to the retrospective design of the study, informed consent of the patients was not necessary. Referee Evaluation Process: Externally peer-reviewed. Conflict of Interest Statement: The authors have no conflict of interest to declare.
Ethics Committee Approval. The Recipient undertakes to obtain any required approval from the competent ethic com- mittee prior to using the Original Biological Resource as part of the Research Project, as further described in the Project Agreement.
Ethics Committee Approval. The Principal Investigator at each site is responsible for obtaining IRB or IEC approval for the protocol, informed consent form/ information sheet, and any advertisements to recruit subjects before being implemented at the investigative site. Written approval of these documents must be obtained from the committee before any subject is enrolled at a center. The Principal Investigator is also responsible for the following interactions with the IRB/IEC: Confidential Information Protocol version 1.1, 21 Aug 2012 Portions of this exhibit have been omitted and filed separately with the SEC pursuant to a confidential treatment request and are indicated by [***]. Protocol VB-201-064 VB-201 • Obtaining IRB/IEC approval for any protocol amendments and informed consent form revisions before implementing the changes; • Providing the IRB/IEC with any required information before or during the study; • Submitting progress reports to the IRB/IEC, as required, during the conduct of the study; requesting re-review and approval of the study, as needed; providing copies of all IRB/IEC re-approvals and relevant communication to the CRO or the Sponsor; • Notifying the IRB/IEC of all serious and unexpected AEs related to the study drug reported by the Sponsor or the CRO, as required. Documentation of this notification should be retained.
Ethics Committee Approval. Prior to beginning the Study, Sponsor shall provide to Site documentation verifying approval by the EC of the Protocol and the information to be provided to potential subjects of the Study to secure their informed consent. 4. Subject Enrollment and Informed Consent. Site and PI shall, in accordance with the Subject eligibility criteria specified in the Protocol and in compliance with Law, use best efforts to enroll poskytne centru, a (z) požadavky platné legislativy. (g) Bezpečnost subjektu. Podle hlavy 21 paragrafu 50 Sbírky federálních předpisů (C.F.R.) Spojených států a jakékoli další legislativy platné pro výzkum na lidských subjektech se zadavatel zavazuje neprodleně informovat HZ o jakýchkoli závažných nežádoucích událostech způsobených hodnoceným přípravkem nebo s ním souvisejících, o nichž se zadavatel dozví prostřednictvím svého monitorovacího procesu nebo výsledků výzkumu, u nichž lze přiměřeně předpokládat, že (i) by mohly mít vliv na bezpečnost nebo lékařskou péči subjektů či jejich ochotu xx xxxx účastnit klinického hodnocení; (ii) významně ovlivní realizaci klinického hodnocení, nebo (iii) povedou ke změně souhlasu EK s pokračováním klinického hodnocení. 2.
Ethics Committee Approval. Ethics Committee Approvals were obtained for each part of the study via the local research ethics committee and were registered with the relevant NHS Research and Development Committees.
Ethics Committee Approval. Prior to the commencement of the Study a copy of the written favorable opinion for the conduct of the Study from a properly constituted Ethics Committee must be delivered to Sponsor or CRO.
