Institutional Review Board. Institution represents that the authorized IRB of Institution is registered in accordance with Applicable Laws, and that such registration will be maintained as current throughout the term of this Agreement and each SOW. For each Study, the Institution shall provide to SPONSOR documentation verifying review and approval by the IRB of (i) the information to be provided to potential Subjects of the Study to secure their informed consent, including information about any compensation being provided to Subjects for participation in the Study (“Informed Consent Materials”), (ii) the Protocol, (iii) the Investigator’s Brochure, if any and (iv) amendments to any of the foregoing. The Institution shall ensure that the IRB continues to monitor and review the Study during the term of the applicable Study in accordance with Applicable Laws and in any event at least once per year during the term of the applicable SOW and shall provide to SPONSOR documentation of the IRB’s continuing review contemporaneously therewith. Institution and/or Principal Investigator must notify SPONSOR in writing immediately if IRB approval of a Study is withdrawn.
Institutional Review Board. This study (protocol, ICF and all addenda) will be reviewed and approved by Sterling IRB. The study will not be activated and subjects will not be consented, receive any study products, or participate in any study procedures until the IRB has approved the protocol and the ICF. In addition, the IRB will review the study before any significant change in the protocol is initiated. After each review, the IRB's approval will be documented in a letter to the Investigator and a copy of the IRB approval letter will be forwarded to the Sponsor.
Institutional Review Board. UC shall obtain the approval of its Institutional Review Board (“IRB”) prior to commencing the Research Program and shall ensure that the IRB oversees the conduct of the study. UC shall comply with the directives of the IRB with respect to the Research Program, and shall notify Sponsor to the extent any such directives vary from the Research Program. In the event UC is unable to obtain IRB approval of the Research Program, the parties may terminate this Agreement without further obligation.
Institutional Review Board. The Institution shall provide to SPONSOR documentation verifying review and approval by the IRB of (i) the information to be provided to potential Subjects of the Study to secure their informed consent, including information about any compensation being provided to Subjects for participation in the Study (“Informed Consent Materials”), (ii) the Protocol, (iii) the Investigator’s Brochure and (iv) amendments to any of the foregoing. The Institution shall ensure that the IRB continues to monitor the Study during the term of this Agreement in accordance with Applicable Laws and in any event at least once per year and shall provide to SPONSOR documentation of the IRB’s continuing review contemporaneously therewith.
Institutional Review Board. (IRB): Responsible for review and approval of research protocols involving the participation of human subjects, and Not Human Subjects Research determinations (as needed) in ESTR Application. The IRB classifies the project as Sensitive or non-Sensitive as part of their review.
Institutional Review Board. Urban warrants that its research activities comply with the U.S. Department of Education’s regulations governing the protection of human subjects in research found in Part 97 of Title 34 of the Code of Federal Regulations. When required by such regulations, Xxxxx shall obtain approval from the appropriate Institutional Review Board prior to submitting any report issued by Urban under this Agreement to OSSE for advance review as further set forth herein.
Institutional Review Board. Institution represents that the authorized IRB of Institution is registered in accordance with Applicable Laws, and that such registration will be maintained as current throughout the term of this Agreement and each SOW. For each Study, the Institution shall provide to SPONSOR documentation verifying review and approval by the IRB of (i) the information to be provided to potential Subjects of the Study to secure their informed consent, including information about any compensation being provided to Subjects for participation in the Study (“Informed Consent Materials”), (ii) the Protocol, (iii) the Investigator’s Brochure and (iv) amendments to any of the foregoing. The Institution shall ensure that the IRB continues to monitor and review the Study during the term of the applicable Study in accordance with Applicable Laws and in any event at least once per year during the term, and shall provide to SPONSOR documentation of the IRB’s continuing review contemporaneously therewith. Institution and Principal Investigator must notify SPONSOR in writing immediately if IRB approval is withdrawn.
Institutional Review Board. Institution represents that the authorized IRB of Institution is registered in accordance with Applicable Laws, and that such registration will be maintained as current throughout the term of this Agreement and each SOW. For each Study, the Institution shall provide to SPONSOR documentation verifying review and approval by the IRB of (i) the information to be provided to potential Subjects of the Study to secure their informed consent, including information about any compensation being provided to Subjects for participation in the Study (“Informed Consent Materials”), (ii) the Protocol, (iii) the Investigator’s Brochure and (iv) amendments to any of the foregoing. The Institution shall ensure that the IRB continues to monitor and review the Study during the term of the applicable Study in accordance with Applicable Laws and in any event at least once per year during the term, and shall provide to SPONSOR documentation of the IRB’s continuing review contemporaneously therewith. Institution and Principal Investigator must notify SPONSOR in writing within immediately if IRB approval is withdrawn. Regulatory Assistance. At the request and expense of SPONSOR, the Institution and the Principal Investigator shall: (a) provide reasonable assistance to SPONSOR in the preparation and submission of investigational device exemption applications for the Study Device(s), device premarket notification (510(k)) submissions, premarket approval applications (PMA) for the Study Device(s), any other premarket or marketing applications relating to a Study or the Study Device(s), and any amendments or supplements to the foregoing; (b) reasonably assist SPONSOR in preparing for meetings with the FDA and other regulatory or governmental authorities regarding such applications and the associated approvals; and (c) provide such other reasonable assistance for a reasonable time period as SPONSOR may request in connection with regulatory matters relating to a Study or the Study Device(s).
Institutional Review Board. The investigator must obtain IRB approval for the investigation. Initial IRB approval, and all materials approved by the IRB for this study including the subject consent form and recruitment materials must be maintained by the investigator and made available for inspection.
Institutional Review Board. [Insert if applicable. Applicable if Subcontract involves the use of human subjects] Institutional Review Board approval must be obtained before any contact with human subjects. All research involving human subjects, or data from or about human subjects, must be conducted in accordance with applicable federal regulations (45 CFR 46 and 21 CFR 50 and 56) and the protocol approved by the IRB. Research activities include contacting Human Subjects, conducting the survey and the collecting and storing of any Human Subject data resulting from this survey. Upon notice of IRB approval, RTI will provide notice to the Subcontractor to commence work. Once this notice is provided to Subcontractor, the Subcontractor may commence with the research activities.
