Investigator’s AgreementInvestigator’s Agreement • September 5th, 2020
The mandate of the Research Review Board Inc. (the “Board”) is to determine that the Application Submission (the “Submission”) and the Study contemplated therein (the “Study”), meet adequate standards of scientific rigor and that the rights and welfare of the Study Candidates are reasonably and adequately protected. The Board may approve the Submission, approve the Submission subject to modifications or conditions, or reject the Submission entirely. The Board is compliant with the composition, operation, and responsibilities of ICH Guidelines for Good Clinical Practice (“GCP”) as stated in Section 3, item 3.1-3.4 and the Canadian Food and Drugs Act, Division 5, Section C.05.001, as amended.
ContractInvestigator's Agreement • March 13th, 2023
Official Title: A Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Sage-217 in the Treatment of Adults With Severe Postpartum Depression
Biobank/ Databank SOPInvestigator’s Agreement • February 13th, 2018
A PROSPECTIVE, RANDOMIZED, DOUBLE- BLINDED, PLACEBO-CONTROLLED TRIAL OF DAXIBOTULINUMTOXINA FOR INJECTION FOR THE MANAGEMENT OF PLANTAR FASCIITISInvestigator's Agreement • December 15th, 2017
INVESTIGATOR’S AGREEMENTInvestigator's Agreement • August 31st, 2021
Role in Study Name Address and Telephone Number Senior Director, Clinical Operations Judy Schnyder 640 Lee RoadSuite 200Wayne, PA 19087484-329-2144jschnyder@aclaristx.com Medical Monitor Esther Estes, MD, MPH 640 Lee RoadSuite 200Wayne, PA 19087484-321-2142eestes@aclaristx.com Serious Adverse Event (SAE) contact Kenneth Kostenbader, MD 640 Lee RoadSuite 200Wayne, PA 19087484-848-7012kkostenbader@aclaristx.com SAE Fax: 484-324-2359
INVESTIGATOR’S AGREEMENTInvestigator's Agreement • November 16th, 2024
PERSETUJUAN PENYELIDIK, PENGESAHAN KETUA JABATAN DAN INSTITUSIInvestigator’s Agreement • February 15th, 2008
This document is intended for online submission for purpose of formal research review and approval. It is to be used in lieu of other equivalent manually printed document such as Borang JTP/KKM 1-2 and Borang JTP/KKM 3. After completing the form below and obtaining the required signatures, please scan this document and submit online.
RTA 402 402-C-1504Investigator's Agreement • October 19th, 2016
The information contained herein is confidential and the proprietary property of Reata Pharmaceuticals, Inc. and any unauthorized use or disclosure of such information without the prior written authorization of Reata Pharmaceuticals, Inc. is expressly prohibited.
INVESTIGATOR’S AGREEMENTInvestigator's Agreement • October 2nd, 2024
This amendment is considered to be substantial based on the criteria set forth in Article 10(a) of Directive 2001/20/EC of the European Parliament and the Council of the European Union.
ProtocolInvestigator's Agreement • March 22nd, 2018
Name of Sponsor/Company: TESARO Name of Investigational Product: TSR-042, bevacizumab, and niraparib Name of Active Ingredient: TSR-042, bevacizumab, and niraparib Title of Study: Phase 2 Multicohort Study to Evaluate the Safety and Efficacy of Novel Treatment Combinations in Patients with Recurrent Ovarian CancerCohort A: PARP Inhibitor-Naïve Platinum-Resistant Ovarian Cancer Treatment Cohort with TSR-042, Bevacizumab, and Niraparib Study center(s): To be determined Principal Investigator: To be determinedInvestigators: To be determined Studied period (years):Estimated date first patient enrolled: Q3 2018 Estimated date last patient completed: Q2 2020 Phase of development: 2 Objectives:Primary:• To evaluate the efficacy of the combination of TSR-042, bevacizumab, and niraparib, as assessed by confirmed objective response rate (ORR), in patients with advanced, relapsed, high-grade ovarian, fallopian tube, or primary peritoneal cancer who have received 1 to 2 prior lines of anticancer t
NCT04480710Investigator's Agreement • June 6th, 2022
Once the protocol has been approved by the Investigational Review Board (IRB) or Independent Ethics Committee (IEC), I will not modify this protocol without obtaining the prior approval of the Sponsor and of the IRB/IEC. I will submit all protocol modifications and/or any informed consent modifications to the Sponsor and the IRB/IEC, and approval will be obtained before any modifications are implemented.
SPONSOR CONTACT LISTInvestigator's Agreement • April 17th, 2024
Abbreviation Term ADA anti-drug antibodies ADC antibody drug conjugate ADCC antibody-dependent cell-mediated cytotoxicity ADL activities of daily living AE adverse event AIBW adjusted ideal body weight ALT alanine aminotransferase (SGPT) ANC absolute neutrophil count aPTT activated partial thromboplastin time ASCO American Society of Clinical Oncology AST aspartate aminotransferase (SGOT) BICR blinded independent central review BIRC blinded independent review committee BRCA breast cancer susceptibility gene BUN blood urea nitrogen C1D1 Cycle 1 Day 1 CI confidence interval CNS central nervous system CR complete response/remission CRO contract research organization CT computed tomography CTCAE Common Terminology Criteria for Adverse Events DM4 N2’-[4-[(3-carboxypropyl)dithio]-4-methyl-1-oxo-2-sulfopentyl]-N2’- deacetylmaytansine S-methyl DM4 methylated N2’-[4-[(3-carboxypropyl)dithio]-4-methyl-1-oxo-2- sulfopentyl]-N2’-deacetylmaytansine DNA deoxyribonucleic acid DOR duration of response
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.
PERSETUJUAN PENYELIDIK, PENGESAHAN KETUA JABATAN DAN INSTITUSIInvestigator’s Agreement • March 8th, 2019
This document is intended for online submission for purpose of formal research review and approval. It is to be used in lieu of other equivalent manually printed document such as Borang JTP/KKM 1-2 and Borang JTP/KKM 3. After completing the form below and obtaining the required signatures, please scan this document and submit online.
ALXN1840Investigator's Agreement • February 21st, 2022
This amendment is considered to be substantial based on the criteria set forth in Article 10(a) of Directive 2001/20/EC of the European Parliament and the Council of the European Union.
Investigators Agreement (704)Investigators Agreement • March 22nd, 2010
Protocol KTE-C19-103 Amendment 6Investigator's Agreement • August 23rd, 2021
• Sub-Investigators (including, if applicable their spouse, legal partner and dependent children) at the start of the study and for up to 1 year after the study is completed at the start of the study and for up to one year after the study is completed.
INVESTIGATOR’S AGREEMENTInvestigator's Agreement • January 9th, 2021
CLINICAL INVESTIGATION SUMMARY Study Title: A multi-center, randomized, controlled, single blinded, parallel-group study evaluating the clinical performance and safety of LiquiBand FIX8® versus control for hernia mesh fixation and peritoneal closure in groin hernia repair. Investigational Device: LiquiBand FIX8® Hernia Mesh Fixation Device Device Description: The device consists of:a) n-butyl-2-cyanoacrylate adhesive monomer, in liquid form, supplied in a thin-walled, sealed glass vial; and,b) a surgically invasive, laparoscopic 5mm diameter cannula, with a handle at the proximal end incorporating a loading chamber, filter, piston chamber and trigger. The distal tip of the device is open to allow the adhesive to be dispensed from it. The device is designed to be used in conjunction with a 5 mm diameter laparoscopic port sleeve. Both the cyanoacrylate adhesive in the glass vial and the surgically invasive delivery device are supplied sterile, for single use only. Indication for Use: Th
PROTOCOL SYNOPSISInvestigator's Agreement • August 18th, 2021
• Assess the response rate (≥ 5 letter gain in Best Corrected Visual Acuity [BCVA] from baseline to week 12according to ETDRS criteria) in participants with persistent central-involved DME receiving combination OPT-302 and aflibercept treatment
