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WS/T 901-2026Specification for quality management system of clinical research in medical institutions - General Principles (English PDF)

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Issued by

National Health Commission

Level / Type

National · Recommended

Issue date

June 10, 2026

Implementation date

December 1, 2026

Scope

WS/T 901-2026 (Specification for quality management system of clinical research in medical institutions - General Principles) is available as an English-translated PDF.

WS/T 901-2026 — This standard specifies the principles, basic content, and quality management requirements for establishing quality management systems for investigator-initiated clinical medical research in medical institutions.

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Document preview — WS/T 901-2026

National Standard of the People's Republic of China

ICS: 11.020
Classification: C 05

Issued by: National Health Commission

What this standard covers1
Document data2

What this standard covers

This standard specifies the principles, basic content, and quality management requirements for establishing quality management systems for investigator-initiated clinical medical research in medical institutions. It applies to the establishment of such systems in hospitals at or above the prefecture-level city level.

Document data

International classification (ICS): 11.020.

Chinese classification (CCS): C05.

Estimated length of the Chinese original: 9,937 words.

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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 7 pages — is available in the English PDF.

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