▍Eligibility
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The AI product must fall within the scope of Software as a Medical Device (SaMD) defined in the TFDA guideline: “Technical Guidance for the Registration of Medical Device Software Utilizing Artificial Intelligence/Machine Learning Technology.”
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The AI product must be registered and approved by TFDA.
▍Application Form
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Online application (click to open in a new window)
Note: After submitting the application form, the system will automatically send an email with a tracking link for real-time application status updates.
▍Application Process
(to be listed/illustrated here)
▍Matching Mechanism
For industry-academia collaboration on clinical trials with NTUH, please fill out the online application form. This allows the hospital to select relevant research teams from the clinical trial talent database according to the disease area, facilitating clinical trial collaboration.
▍Fee Structure
Submission of study protocols to the Central Institutional Review Board (CIRB) will incur fees according to the “NTUH AI Center Project Alliance Hospital Ethics Review Operation Guidelines”. Relevant links: NTUH IRB, Fu Jen University IRB, Min-Sheng IRB.
For studies approved by the CIRB, the clinical trial budget will be allocated after discussion with the principal investigator. Budget allocation principles refer to the “NTUH Clinical Trial and Clinical Research Contract Signing Guidelines”.
Signing the study contract requires payment of the Administrative Fee for Pre-Trial Preparation of Clinical Research Commissioned Projects.