Clinical Trial Design and Regulatory Requirements for Artificial Intelligence as a Medical Device: A PRISMA-ScR–Guided Scoping Review of Global Guidance and Evidence (2017–2025).
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| Title: | Clinical Trial Design and Regulatory Requirements for Artificial Intelligence as a Medical Device: A PRISMA-ScR–Guided Scoping Review of Global Guidance and Evidence (2017–2025). |
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| Authors: | Shanmugam, Umamaheswari1 (AUTHOR), Rajendran, Mohan Kumar2 (AUTHOR), Natarajan, Jawahar1 (AUTHOR), Karri, Veera Venkata Satyanarayana Reddy1,2 (AUTHOR) |
| Source: | Journal of Clinical Medicine. Mar2026, Vol. 15 Issue 5, p1937. 21p. |
| Database: | Academic Search Ultimate |
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| FullText | Links: – Type: pdflink Text: Availability: 1 |
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| Header | DbId: asn DbLabel: Academic Search Ultimate An: 192623876 AccessLevel: 2 PubType: Academic Journal PubTypeId: academicJournal PreciseRelevancyScore: 0 |
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| Items | – Name: Title Label: Title Group: Ti Data: Clinical Trial Design and Regulatory Requirements for Artificial Intelligence as a Medical Device: A PRISMA-ScR–Guided Scoping Review of Global Guidance and Evidence (2017–2025). – Name: Author Label: Authors Group: Au Data: <searchLink fieldCode="AR" term="%22Shanmugam%2C+Umamaheswari%22">Shanmugam, Umamaheswari</searchLink><relatesTo>1</relatesTo> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Rajendran%2C+Mohan+Kumar%22">Rajendran, Mohan Kumar</searchLink><relatesTo>2</relatesTo> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Natarajan%2C+Jawahar%22">Natarajan, Jawahar</searchLink><relatesTo>1</relatesTo> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Karri%2C+Veera+Venkata+Satyanarayana+Reddy%22">Karri, Veera Venkata Satyanarayana Reddy</searchLink><relatesTo>1,2</relatesTo> (AUTHOR) – Name: TitleSource Label: Source Group: Src Data: <searchLink fieldCode="JN" term="%22Journal+of+Clinical+Medicine%22">Journal of Clinical Medicine</searchLink>. Mar2026, Vol. 15 Issue 5, p1937. 21p. |
| PLink | https://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=asn&AN=192623876 |
| RecordInfo | BibRecord: BibEntity: Identifiers: – Type: doi Value: 10.3390/jcm15051937 Languages: – Code: eng Text: English PhysicalDescription: Pagination: PageCount: 21 StartPage: 1937 Titles: – TitleFull: Clinical Trial Design and Regulatory Requirements for Artificial Intelligence as a Medical Device: A PRISMA-ScR–Guided Scoping Review of Global Guidance and Evidence (2017–2025). Type: main BibRelationships: HasContributorRelationships: – PersonEntity: Name: NameFull: Shanmugam, Umamaheswari – PersonEntity: Name: NameFull: Rajendran, Mohan Kumar – PersonEntity: Name: NameFull: Natarajan, Jawahar – PersonEntity: Name: NameFull: Karri, Veera Venkata Satyanarayana Reddy IsPartOfRelationships: – BibEntity: Dates: – D: 01 M: 03 Text: Mar2026 Type: published Y: 2026 Identifiers: – Type: issn-print Value: 20770383 Numbering: – Type: volume Value: 15 – Type: issue Value: 5 Titles: – TitleFull: Journal of Clinical Medicine Type: main |
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