Protocol Number. IHLOSAPOC1Site: University of Western Australia_FINAL Equipment means the equipment supplied to the Institution by or on behalf of the Sponsor for the purposes of the Study, including that specified in Schedule 1.
Protocol Number. The above-named Individual Investigator has reviewed: 1) The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research (or other internationally recognized equivalent; see section B.1. of the Terms of the Federalwide Assurance (FWA) for International (Non-U.S.) Institutions); 2) the U.S. Department of Health and Human Services (HHS) regulations for the protection of human subjects at 45 CFR part 46 (or other procedural standards; see section B.3. of the Terms of the FWA for International (Non-U.S.) Institutions); 3) the FWA and applicable Terms of the FWA for the institution referenced above; and 4) the relevant institutional policies and procedures for the protection of human subjects. The Investigator understands and hereby accepts the responsibility to comply with the standards and requirements stipulated in the above documents and to protect the rights and welfare of human subjects involved in research conducted under this Agreement. The Investigator will comply with all other applicable federal, international, state, and local laws (including tribal laws passed by the official governing body of an American Indian or Alaska Native tribe), regulations, and policies that may provide additional protection for human subjects participating in research conducted under this agreement. The Investigator will abide by all determinations of the Fred Hutch Institutional Review Board (IRB) designated under the above FWA and will accept the final authority and decisions of the IRB/IEC, including but not limited to directives to terminate participation in designated research activities. The Investigator will complete any educational training required by the Institution and/or the IRB under Fred Hutch IRB Policy 2.20 Training (038) prior to initiating research covered under this Agreement. This includes training on Human Subject Protection and, when applicable, training in Good Clinical Practice. The Investigator will report promptly to the IRB/IEC any proposed changes in the research conducted under this Agreement. The investigator will not initiate changes in the research without prior IRB review and approval, except where necessary to eliminate apparent immediate hazards to subjects. The Investigator understands that some problems must be reported to the IRB promptly. Examples of problems to report promptly include: Unanticipated Problems Involving Risks to Subjects or Others which are unexpected, related or possible re...
Protocol Number. Lm-LLO-E7-07 (conducted in the United States) Protocol Title: A Randomized, Single Blind, Placebo Controlled Phase 2 Study to Assess the Safety and Efficacy of Lovaxin C for the Treatment of Cervical Intraepithelial Neoplasia Grade 2/3. Pursuant to the Master Agreement entered into by Advaxis, Inc. ("ADVAXIS") and Numoda Corporation ("Numoda") on June 19, 2009 ("MA"), this Project Agreement (PA) and attachments, including:
Protocol Number. IFX-1-P2.5
Protocol Number. 1321.7 Protocol Title: “Single dose, open label, uncontrolled, safety trial of intravenous administration of idarucizumab to paediatric patients enrolled from ongoing phase IIb/III clinical trials with dabigatran etexilate for the treatment and secondary prevention of venous thromboembolism“ as amended (hereinafter referred to as the “Trial Protocol”) both together hereinafter referred to as “Trial” The planned Trial start date is July 2017 (expected recruitment period: 12 months at least). The Trial shall be performed in different departments of University hospital Brno, Xxxxxxxxx 00, 000 00 Xxxx, Xxxxx Xxxxxxxx (“Institution”) as the patients will be assigned to the relevant department depending on the individual diagnosis of each patient. (University hospital Brno, Department of Pediatric Hematology, Černopolní 9, 613 00 Brno) as Principal Investigator will be responsible for Trial run.
