Investigator Agreement and Signature:Investigator’s Agreement • November 7th, 2021
The current version of the protocol was released on 16 April 2018 and includes Amendment 1. For all protocol amendments, amendment forms were prepared and are provided in Appendix 2.0 (see Table 1).
INVESTIGATOR’S AGREEMENTInvestigator’s Agreement • June 25th, 2020
Sub-Investigators (including, if applicable their spouse, legal partner, and dependent children) at the start of the study and for up to one year after the study is completed.
INVESTIGATOR’S AGREEMENTInvestigator’s Agreement • August 5th, 2021
ITT intent-to-treat LPM liters per minute MCP-1 monocyte chemoattractant protein 1 MIF-1α macrophage inflammatory protein 1α MM multiple myeloma MODS multiple organ dysfunction syndrome MW molecular weight NCI CTCAE National Cancer Institute Common Terminology Criteria for Adverse Events NES nuclear export sequence NF-κB nuclear factor κb NG Nasogastric NHBE normal human bronchial epithelial NSAID nonsteroidal anti-inflammatory drugs OSI Ordinal Scale for Clinical Improvement PEG percutaneous endoscopic gastrostomy PFS progression-free survival PHI protected health information PPARγ peroxisome proliferator-activated receptor γ PR partial response QoD every other day RNA ribonucleic acid RNP Ribonucleoprotein RRMM relapsed/refractory multiple myeloma RSV respiratory syncytial virus
INVESTIGATOR'S AGREEMENT, HEAD OF DEPARTMENT AND ORGANISATIONAL / INSTITUTIONAL APPROVAL PERSETUJUAN PENYELIDIK DAN KEBENARAN KETUA JABATAN DAN PENGARAH ORGANISASI/INSTITUSIInvestigator's Agreement • January 20th, 2021
This document is intended for online submission for formal research registration. It is issued as the Investigator's Agreement to participate in the research as well as the investigator’s Head of Department and Director’s Approval. Please upload this document in the required section in NMRR upon completion.
INVESTIGATOR’S AGREEMENTInvestigator’s Agreement • December 17th, 2021
Name of Sponsor/Company:La Jolla Pharmaceutical Company (La Jolla) Name of Investigational Product:LJPC-501 (angiotensin II) Name of Active Ingredient:angiotensin II Title of study:An Open-label, Multi-Center Study of LJPC-501 in Pediatric Patients Who Remain Hypotensive Despite Receiving Fluid Therapy and Vasopressor Therapy Number of study center(s): Approximately 10 Objectives:Primary:• To evaluate the effect of LJPC-501 infusion on mean arterial pressure (MAP) or reduction in sum norepinephrine-equivalent dose (NED), at Hour 2 after the start of LJPC-501, in pediatric patients who remain hypotensive despite receiving fluid therapy and vasopressor therapy.Secondary:• To establish the safety and tolerability of LJPC-501 in pediatric patients• To evaluate the change in MAP over 24 hours after the start of LJPC-501• To evaluate the change in serum lactate concentrations• To evaluate change in Pediatric Logistic Organ Dysfunction (PELOD) scores Methodology:ScreeningDuring Screening, the
Investigators Agreement (704)Investigators Agreement • March 22nd, 2010
NCCS Principal Investigator’s AgreementInvestigator’s Agreement • July 22nd, 2009
The National Center for Computational Sciences (NCCS) must have a signed copy of this form on file from the project's principal investigator(s) (PI) before any accounts for the project will be processed. Please submit the completed form to the NCCS at Oak Ridge National Laboratory (ORNL) by fax at 865-241-4011 or email to accounts@ccs.ornl.gov. Direct any questions to accounts@ccs.ornl.gov.
