IDE APPLICATION TEMPLATE: EXAMPLE OF INVESTIGATOR’S AGREEMENT/CERTIFICATION OF FINANCIAL INTERESTInvestigator Agreement • February 15th, 2024
I, ______________________, agree to participate as the Principal Investigator in the clinical investigation of the __________________________________ (specify investigational device).
Investigator Agreement:Investigator Agreement • June 2nd, 2023
• I have read the clinical study described herein, recognize its confidentiality, and agree to conduct the described trial in compliance with Good Clinical Practices; applicable international and national regulations, laws, guidelines, and standards; the conditions of approval imposed by the reviewing IRB or regulatory authority; and in accordance with the ethical medical research principles outlined in the Declaration of Helsinki.
Investigator Agreement and Signature:Investigator 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 AgreementInvestigator Agreement • March 5th, 2024
INVESTIGATOR AGREEMENT FOR A CLINICAL INVESTIGATION OF THE (Specify Investigational Device) (Protocol Number and Study Title)Investigator Agreement • September 8th, 2023
Clinical investigation means any experiment that involves a test article and one or more human subjects and that either is subject to requirements for prior submission to the Food and Drug Administration under section 505(i) or 520(g) of the act, or is not subject to requirements for prior submission to the Food and Drug Administration under these sections of the act, but the results of which are intended to be submitted later to, or held for inspection by, the Food and Drug Administration as part of an application for a research or marketing permit.
Investigator AgreementInvestigator Agreement • March 24th, 2022
INVESTIGATOR AGREEMENT FOR THE CLINICAL INVESTIGATION OF THE (_______)Investigator Agreement • September 1st, 2021
All investigators have signed this agreement and no additional investigator will be added until the agreement is signed.
POST-ICECAP Investigator Agreement Form - pursuant to 21 CFR 812.43(c)Investigator Agreement • May 5th, 2022
Submission of this form to the sponsor from a participating investigator represents the participating investigator’s assurance of the following:
Investigator AgreementInvestigator Agreement • July 27th, 2022
Food and Drug Administration, HHS §812.47Investigator Agreement • January 27th, 2015
( c) Obtaining agreements. A spo n so r s h a ll ob t a i n f r o m e a c h p a r t icip a t i n g i n ves t ig a t o r a s ig n ed a g r ee m e n t t h a t i n cl u des:
Investigator AgreementInvestigator Agreement • August 31st, 2017
As an Investigator for the study, I agree to adhere to the clinical plan as set forth in the protocol to the best of my ability and will conduct the study according to the protocol and applicable regulatory guidelines.
Investigator AgreementInvestigator Agreement • February 17th, 2010
The biofeedback software research is to study millions of people with a wide variety of diseases to see who gets or feels better with stress reduction.
Investigator AgreementInvestigator Agreement • February 20th, 2018
The IRB reserves the right to terminate this study at any time if, in its opinion, (1) the risks of further experimentation are prohibitive, or (2) the above agreement is breached.
INVESTIGATOR AGREEMENTInvestigator Agreement • October 14th, 2021
In every cohort, a loading dose of KPL-716 at 720 mg SC (or matching placebo) will be followed by maintenance doses of 360 mg SC (or matching placebo) administered every week for 7 additional weekly doses in order to detect an early signal of efficacy on pruritus once exposures approach an expected steady state. In addition, the impact of KPL-716 on sleep and quality of life will be assessed. Furthermore, the impact of KPL-716 on urticaria in CIU (Cohort 1) will be investigated.
Investigator Agreement:Investigator Agreement • July 12th, 2021
• I have read the clinical study described herein, recognize its confidentiality, and agree to conduct the described trial in compliance with Good Clinical Practice (GCP), the ethical principles contained within the Declaration of Helsinki, this protocol, all applicable regulatory authority regulations, and conditions of approval imposed by the reviewing IRB or regulatory authority.
U VA Biorepository & Tissue Research Facility (BTRF) Investigator Agreement & Study Information Form Do not use this form to request support for investigator-initiated or sponsored clinical trials.Investigator Agreement • December 19th, 2018
INVESTIGATOR AGREEMENTInvestigator Agreement • April 1st, 2019
Principal Investigator’s name Lupin Representative's name Signature Signature Date (dd-Mmm-yyyy) Date (dd-Mmm-yyyy) Institution
Investigator Agreement:Investigator Agreement • April 16th, 2021
• I have read the clinical study described herein, recognize its confidentiality, and agree to conduct the described trial in compliance with Good Clinical Practice (GCP), the ethical principles contained within the Declaration of Helsinki, this protocol, all applicable regulatory authority regulations, and conditions of approval imposed by the reviewing IRB or regulatory authority.
INVESTIGATOR AGREEMENTInvestigator Agreement • March 7th, 2024
Investigator AgreementInvestigator Agreement • August 17th, 2020
The above-named Investigator has reviewed The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research, the U.S. Department of Health and Human Services regulations for the protection of human subjects at 45 CFR 46 and 21 CFR 50, 56 (for FDA-regulated studies) and The University of South Dakota Institutional Review Board (IRB) policies.
Investigator Agreement:Investigator Agreement • April 22nd, 2021
I have read the clinical study described herein, recognize its confidentiality, and agree to conduct the described trial in compliance with Good Clinical Practice (GCP), the ethical principles contained within the Declaration of Helsinki, this protocol, all applicable regulatory authority regulations, and conditions of approval imposed by the reviewing IRB or regulatory authority.
ContractInvestigator Agreement • November 14th, 2018
SMLOUVA SNEMOCNICÍ/ZKOUŠEJÍCÍM HOSPITAL / INVESTIGATOR AGREEMENT pro klinické hodnocení NUC–5/PSC to Clinical Trial NUC-5 / PSC mezi between Dr. Falk Pharma GmbH Leinenweberstr. 579108 Freiburg/Německo Dr. Falk Pharma GmbH Leinenweberstr. 579108 Freiburg/Germany dále uváděná jako „zadavatel“ hereafter referred to as „Sponsor“, a and University Hospital Plzeň Edvarda Beneše 1128/13 305 99 PlzeňCzech Republic University Hospital Plzeň Edvarda Beneše 1128/13 305 99 PlzeňCzech Republic dále uváděné jako „zdravotnické zařízení“ hereafter referred to as „Institution“ zastoupená represented by MUDr. Václav Šimánek, Ph.D Ředitel MUDr. Václav Šimánek, Ph.D Director a hlavním zkoušejícím MUDr. Vaclav Hejda and the Principal Investigator MUDr. Vaclav Hejda dále uváděný jako „zkoušející“ hereafter referred to as „Investigator“ Úvodní ustanovení Preamble Společnost Dr. Falk Pharma GmbH jakožto zadavatel má v úmyslu provádět klinickou studii s hodnoceným přípravkem – kyselinou norursodeoxycholovou.
Protocol GLI.04.US.SL.015 CONFIDENTIALInvestigator Agreement • June 16th, 2024
Title A randomized, split-face clinical study on comparative ultrasound analysis of two Hyaluronic Acid fillers for midface correction Protocol number: GLI.04.US.SL.015 Sponsor name and address: Galderma Laboratories, L.P. 14501 North FreewayFort Worth, TX 76177 USA Test products: Restylane® Contour Juvéderm® Voluma® Investigator agreement: I have read the clinical study described herein, recognize its confidentiality, and agree to conduct the described study in compliance with Good Clinical Practices (GCP), the ethical principles contained within the Declaration of Helsinki, this protocol, and all applicable regulatory requirements. Principle Investigator: Signature Date Name: Steve F. Weiner, MD Address: The Aesthetic Clinique2050 West County Highway 30A Suite 114 Santa Rosa Beach, FL 32459USATelephone: 1-850-600-6997
Investigator Agreement:Investigator Agreement • March 9th, 2020
I have read the clinical study described herein, recognize its confidentiality, and agree to conduct the described trial in compliance with Good Clinical Practice (GCP), the ethical principles contained within the Declaration of Helsinki, this protocol, all applicable regulatory authority regulations, and conditions of approval imposed by the reviewing IRB or regulatory authority.
INVESTIGATOR’S AGREEMENTInvestigator Agreement • July 28th, 2023
Abbreviation Definition AE adverse event ALT alanine transaminase ANC absolute neutrophil count ARC absolute reticulocyte count AST aspartate transaminase AUC area under the concentration-time curve BID twice daily BIW biweekly BOR best overall response BP blood pressure BSA body surface area BUN blood urea nitrogen C cycle CEA carcinoembryonic antigen CFR Code of Federal Regulations CI confidence interval Cmax maximum plasma concentration CONSORT Consolidated Standards of Reporting Trials CPI checkpoint inhibitor CR complete response CRC colorectal cancer CrCl creatinine clearance CT computed tomography CTCAE Common Terminology Criteria for Adverse Events CYP3A cytochrome P450 3A D day DCR disease control rate DLBCL diffuse large B-cell lymphoma dMMR deficient mismatch repair DNA deoxyribonucleic acid DOR duration of response
Protocol GLI.04.US.SL.017 CONFIDENTIALInvestigator Agreement • May 2nd, 2023
Title A multi-center, prospective pilot study on safety and effectiveness of a healing ointment as a post-surgical care Protocol number: GLI.04.US.SL.017 Sponsor name and address: Galderma Laboratories, L.P. 14501 North FreewayFort Worth, TX 76177 USA Test product: Cetaphil® Healing Ointment Investigator agreement: I have read the clinical study described herein, recognize its confidentiality, and agree to conduct the described study in compliance with Good Clinical Practices (GCP), the ethical principles contained within the Declaration of Helsinki, this protocol, and all applicable regulatory requirements. Principle Investigator: Signature Date Name: Aaron Farberg, MD Address: Derm Texas2110 Research RowDallas, TX 75235 USATelephone: (214) 845-6426 Legacy Dermatology 3140 Legacy Dr., #110Frisco, TX 75034 USATelephone: (972) 787-0010
INVESTIGATOR AGREEMENT PAGEInvestigator Agreement • November 28th, 2022
Protocol Title: A Phase 1 Study of the EZH2 Inhibitor Tazemetostat in Pediatric Subjects with Relapsed or Refractory INI1-Negative Tumors or Synovial Sarcoma
Investigator Agreement:Investigator Agreement • August 13th, 2022
α Comprehensive details of all AEs will be documented in the source records; however, targeted collection will be utilized in the eCRF.
ContractInvestigator Agreement • August 29th, 2017
ContractInvestigator Agreement • October 23rd, 2023
Investigator Agreement between ICON Clinical Research Limited,, Slezská nemocnice v Opavě and Bayer Pharma AG on the performance of the clinical trial entitled A multinational, randomised, double-blind, placebo- controlled, phase III efficacy and...Investigator Agreement • December 18th, 2017
Assignment of Clinical Investigator Agreement to Bayer AG Postoupení smlouvy o zabezpečení a provedeníklinického hodnocení společnosti Bayer AG Dear Sir, Vážený pane doktore, 1. We would like to inform You that As part of the overall restructuring of the Bayer Group, Bayer Pharma AG will transfer its assets to the new sponsor of the Study, Bayer AG, including the Agreement. 1. rádi bychom Vás informovali, že v rámci celkové restrukturalizace skupiny Bayer Group převede společnost Bayer Pharma AG svá aktiva včetně smlouvy na nového zadavatele studie, společnosti Bayer AG. This is to advise You that effective as of 1st January 2017, Bayer Pharma AG assigned the Agreement to its affiliate Bayer AG. Consequently, all the rights and obligations of Bayer Pharma AG under the Agreement were transferred to Bayer AG. Against this background, we kindly ask You for Your consent to the transfer of the Agreement to Bayer AG by countersigning the attached assignment agreement and returning it to us T
Standard Investigator Agreement- Abandoned PropertyInvestigator Agreement • January 4th, 2007
This agreement is entered into by and between , hereinafter referred to as "Claimant," and , hereinafter referred to as "Investigator."
IRB-HSR PROTOCOLInvestigator Agreement • August 19th, 2023
Investigator Agreement:Investigator Agreement • January 4th, 2023
• I have read the clinical study described herein, recognize its confidentiality, and agree to conduct the described trial in compliance with Good Clinical Practice (GCP), the ethical principles contained within the Declaration of Helsinki, this protocol, and any conditions of approval imposed by the Institutional Review Board and/or the FDA, and all applicable regulatory requirements including 21 CFR
Investigator AgreementInvestigator Agreement • April 23rd, 2018
transferred to another institution. A copy of the documents may be taken with the Principal investigator when transferring to another institution.
