IDE Investigator Agreement - For the Clinical Investigation of the (Specify Investigational Device)

Sep 2, 2026

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IDE Investigator Agreement template用于临床研究中指定研究器械的申办人与研究者之间签署。协议要求研究者确认具备相应资质，并附上最新履历或相关资质说明，同时披露是否曾因不合规被终止的情况及必要说明。研究者承诺按协议、研究计划、IDE法规及IRB批准条件开展研究、监督涉及人类受试者的设备测试，并确保知情同意要求落实。文中还规定研究者需通过财务利益认证与必要披露表向赞助方提供准确且持续更新的财务信息，并包含主要研究者及共同研究者签署栏位。

LanguageEnglish

CategoryLetters

FormatDOCX

Pages2

Reading Time1 min

AccessFree to download

IDE Investigator Agreement

Investigator obligations and qualifications

Financial interest certification and disclosure

Principal Investigator signature block

Physician co-investigator section

Non-physician co-investigator section

Please use UA letterhead issued by your own department. IDE INVESTIGATOR AGREEMENT FOR THE CLINICAL INVESTIGATION OF THE (Specify Investigational Device) IDE #: [insert IDE #] Sponsor: [insert Sponsor name] Protocol title: [insert protocol title] Investigator Name: [insert name of investigator] Location(s) of study activities: [insert each address] I agree and/or certify that: I have the appropriate, relevant qualifications to conduct and oversee the conduct of the clinical investigation, as documented by the following: The most recent curriculum vitae (CV) is attached to this Agreement. The CV includes information about my relevant experience, including dates, locations, extent, and type of experience. If the CV does not reflect my relevant qualifications, a summary of my relevant experience is attached. I have not participated in an investigation or had other research activity that was terminated by the FDA, the reviewing IRB or sponsor due to a non-compliance issue. If applicable, an explanation of the circumstances that led to the investigation or termination is attached. As an investigator, I will commit to: Conduct the clinical investigation in accordance with this agreement, all requirements of the investigational plan, IDE regulations, other applicable regulations of the FDA, and conditions of approval by the reviewing IRB, Supervise all testing of the device involving human subjects, and Ensure that the requirements for obtaining informed consent are met. I will disclose sufficient and accurate financial information to the sponsor (sponsor-investigator) by completing the Certification of Financial Interest form (attached) and if applicable, the Disclosure of Financial Interest form (attached). I will also notify the sponsor (sponsor-investigator) if my disclosed financial information changes at any time during the clinical investigation or up to one year following the closure of the study. PRINCIPAL INVESTIGATOR ____________________________________________ Name of Principal Investigator (please print or type) _________________________________________ Office (Mailing Address) ______________________________ ______________________________ City/State/Zip E-mail ______________________________ ______________________________ Telephone Fax ____________________________________________ ______________ Signature of Principal Investigator Date PHYSICIAN CO-INVESTIGATORS (i.e., physicians participating as co- or sub-investigators on this clinical investigation under supervision of the Principal Investigator): A current CV or statement of relevant experience and a completed Certification of Financial Interest form and, if applicable, Financial Interest Disclosure form is required to be submitted to the sponsor (sponsor-investigator) for each physician co-investigator listed below. As a physician co-investigator for this investigation, I have read the foregoing and agree to be bound by its terms. ____________________________________________ Name of Physician Co-Investigator (please print or type) ____________________________________________ ____________ Signature Date NON-PHYSICIAN CO-INVESTIGATORS (i.e., non-physicians participating as co- or sub-investigators on this clinical investigation under supervision of the Principal Investigator): A current CV or statement of relevant experience and a completed Certification of Financial Interest form and, if applicable, a Financial Interest Disclosure form is required to be submitted to the sponsor (sponsor-investigator) for each non-physician co-investigator listed below. As a non-physician co-investigator for this investigation, I have read the foregoing and agree to be bound by its applicable terms. _____________________________________________ Name of Co-Investigator (please print or type) _____________________________________________ ____________ Signature

FAQs

研究者需要确认哪些资质与经验？

研究者需确认具备开展与监督该临床调查的相关资质，并通过附加最新简历（CV）或补充的相关经验摘要来证明，内容包括时间、地点、经历范围与类型。

若过去因不合规导致研究终止，协议要求如何处理？

研究者需声明自己未参与过因不合规问题而被FDA、审查IRB或赞助方终止的调查或其他研究活动；如适用，需要附上导致调查或终止的情形说明。

研究者在财务利益披露方面有哪些要求？

研究者需完成所附“财务利益认证”表（及如适用的“财务利益披露”表）向赞助方披露足够且准确的财务信息，并在临床调查期间或研究结题后一年内如财务信息发生变化及时通知。

谁需要签署该协议，签署栏位包含哪些类型的研究者？

协议包含主要研究者（Principal Investigator）签署，以及医生共同研究者（Physician co-investigators）与非医生共同研究者（Non-physician co-investigators）签署部分。共同研究者需提交各自的CV或相关经验声明，并完成财务利益认证及如适用的披露表。

Sep 2, 2026

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