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).
Individual Investigator Agreement (IIA)Investigator Agreement • February 24th, 2023
There are instances when an external individual is engaged in human subjects research, in collaboration with a Pitt or UPMC researcher. In most cases, that individual does not have access to an IRB to provide approval and/or oversight for the research activities being performed. For these situations, an Individual Investigator Agreement (IIA) may be appropriate. IIAs are not required for exempt level studies. All inquiries related to an IIA should be directed to irb.reliance@pitt.edu.
Individual Investigator Agreement (Institutional)Investigator Agreement • May 28th, 2021
IRB Individual Investigator Agreement (IIA) – Campbell as IRB of RecordInvestigator Agreement • July 20th, 2021
This form should only be used for collaborative research when research will be conducted at an institution which does not have a Federalwide Assurance/IRB.
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.
Individual Investigator Agreement (IIA) Version 12-09-19Investigator Agreement • November 23rd, 2021
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.
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.
Individual Investigator Agreement (Independent)Investigator Agreement • March 23rd, 2022
Investigator AgreementInvestigator Agreement • July 27th, 2022
Individual Investigator AgreementInvestigator Agreement • June 8th, 2021
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);
NON-AFFILIATED INVESTIGATOR AGREEMENTInvestigator Agreement • September 17th, 2020
Investigator Agreement:Investigator Agreement • February 13th, 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 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 • 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 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 • March 5th, 2024
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.
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 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 • October 23rd, 2023
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:Investigator Agreement • June 1st, 2022
• 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.
RU Institutional Review Board: Investigator AgreementInvestigator Agreement • August 22nd, 2017
Investigator Agreement:Investigator Agreement • March 6th, 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.
IDE INVESTIGATOR AGREEMENT FOR THE CLINICAL INVESTIGATION OF THE (Specify Investigational Device)Investigator Agreement • December 11th, 2020
I, ______________________, agree to participate as the Principal Investigator in the clinical investigation of the __________________________________ (specify investigational device).
Investigator Agreement:Investigator Agreement • March 31st, 2022
• 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 • June 4th, 2006
This agreement is entered into by and between R-Research with its principle office and place of business at , hereinafter called R-Research, and (physician) affiliated with (facility name) with its principal office at
Individual Investigator AgreementInvestigator Agreement • January 9th, 2019
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.
ContractInvestigator Agreement • September 19th, 2016
INSTITUTION/INVESTIGATOR AGREEMENT SMLOUVA SE ZKOUŠEJÍCÍM/ZDRAVOTNICKÝMZAŘÍZENÍM This Institution and Investigator Agreement (this “Agreement”) is entered into this 07 Sep 2016 (the “Effective Date”), by and between ICON Clinical Research Limited,VAT number IE 8201978Rwith a place of business at South County Business Park, Leopardstown Dublin 18, Ireland, represented by PharmDr.Pavel Lebesle MBA, Director Project Management (hereinafter referred to as “Company”) and Fakultni nemocnice Brnowith a registered address Jihlavska 20, 625 00 Brno, Czech Republic, Company ID: 65269705 VAT ID No.:CZ65269705 represented by MUDr. Roman Kraus, MBA, hospital director,(hereinafter referred to as “Institution”) and XXX(hereinafter referred to as “ Principal Investigator”) Tato smlouva se zdravotnickým zařízením a zkoušejícím (dále „smlouva”) se uzavírá dne07. září 2016 (dále „datum účinnosti”), mezispolečností ICON Clinical Research Limited DIČ IE 8201978R,se sídlem na adrese South County Business Pa
PROTOCOL INVESTIGATOR AGREEMENTInvestigator Agreement • August 23rd, 2023
• To conduct the study in compliance with this protocol, any future protocol amendments, with the terms of the study agreement and with any other study conduct procedures and/or study conduct documents provided by GSK.
