Study Title. This agreement outlines the responsibilities between the above named individual, the University of California, Irvine (UCI), the responsible Institutional Review Board (IRB), and the above named Lead Researcher (LR) of the above named study at UCI. INDIVIDUAL INVESTIGATOR CERTIFICATIONS: I understand that individuals are engaged in human research whenever: (a) an individual intervenes or interacts with human subjects for research purposes; or (b) the individual obtains identifiable private information about human subjects for research purposes. I accept responsibility for safeguarding the rights and welfare of each research subject I interact with on this project, and I understand that the subject’s rights and welfare must at all times come before the goals and requirements of the research. I will provide evidence of human research educational training at my institution, or I will complete the UCI Human Research Protections educational training and provide evidence of completion prior to initiating research covered under this Agreement. I will conduct the research as approved by the IRB and I will not make any changes in the research without prior IRB review and approval, except where necessary to eliminate apparent immediate hazards to participants. I will report immediately to the LR any unfavorable occurrence or any unanticipated problems involving risks to participants or others in research covered under this Agreement. If I am responsible for enrolling subjects, I will obtain, document, and maintain records of informed consent for each such subject or each subject’s legally authorized representative following the methods described in the approved study. Upon conclusion of the study, these records will be transferred to the LR for appropriate maintenance and storage. I will promptly report to the LR, IRB, or the institutional official listed below any noncompliance with the standards or requirements reference in this Agreement, whether by the Investigator, any co-investigators, research staff, or others, regardless of fault or intent. I will abide by all determinations of the IRB and provide all information requested by the IRB or the PI in a timely manner. I will provide the names of any individuals engaged in the research who are working under my direction to the LR and the IRB. I will comply with all other applicable federal, international, state, and local laws, regulations, and policies that may provide additional protection for human subjects par...
Study Title. Randomised, Double-blind, Placebo-controlled, Xxxxxxxx-xxxxx, Xxxxx 0 Study to Evaluate the Effect of One Dose of PBT2 (250mg daily) for 52 Weeks on Aβ Deposition in the Brains of Patients with Mild Alzheimer’s Disease Compared to Placebo and to Evaluate the Safety and Tolerability of PBT2 (250mg daily) for 52 Weeks in Patients with Mild Alzheimer’s Disease The parties hereby agree as follows:
Study Title. It is agreed as follows:
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Study Title. Protocol Number (Rutgers University)
Study Title. Phase 1-2 Study of ADXS11-001 or MEDI-4376 Alone or Combination In Previously Treated Locally Advanced or Metastatic HPV+ Cervical or Head & Neck Cancer Type of Study: Randomized open-label Phase 1 with Phase 2 expansion cohort Study Centers: Multicenter: 1. Georgia Reagents University Cancer Center, [c.i.] 2. Others to be determined. Objectives: Primary objective: Phase 1 ● To evaluate the safety and tolerability of ADXS11-001 or MEDI-4736 alone and in combination (ADXS11-001 + MEDI-4736) administered in repeating cycles in previously treated locally advanced or metastatic HPV+ head & neck cancer ● Select a regimen for Phase 2 expansion based on safety, tolerability, evidence of clinical activity and correlative studies Primary Objective: Phase 2 expansion ● To develop an estimate of clinical activity including: tumor responses, progression-free survival (PFS) by immune-related response evaluation criteria (irRECIST) and overall survival for a Phase 2 efficacy estimate. Secondary Objectives ● Describe and evaluate data from correlative immunologic and pathologic studies, along with other exploratory investigations to patient outcomes. Methodology: [c.i.] The Number of Patients Planned: [c.i] Diagnosis and Main Criteria for Eligibility: [c.i.] Test Product, Dose, Mode of Administration: [c.i.] Reference Therapy: [c.i.] Study Duration: [c.i.] Criteria for Evaluation: [c.i.] Statistical Methods: [c.i.] Schema [c.i.] Table 1 Schedule of Dosing and Efficacy Assessments–ADXS11-001 Monotherapy [c.i.] Table 2 Schedule of Dosing and Efficacy Assessments–MEDI-4736 Monotherapy [c.i.] Table 3 Schedule of Dosing and Efficacy Assessments–ADXS11-001 + MEDI-4736 Combination Therapy [c.i.] Appendix B Samples Analysis/Assays Procedures [c.i.]
Study Title. Director of the Coordinating Center: Protocol Number: This Task Order is entered into by and between Hesperion Ltd. ("Hesperion") and NovaCardia, Inc. ("NovaCardia") as a Task Order to the Master Clinical Services Agreement which was entered into by the parties effective (the "Master Agreement") and to establish specific terms for the conduct of the above referenced study (the "Study"). Capitalized terms used herein and not otherwise defined shall have the meaning set forth in the Master Agreement.
Study Title. Click here to enter text. ____________________________________ _______________ Signature Date
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