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Preliminary exploration of the construction of a qualification evaluation system for primary investigators in clinical trials based on the Delphi method
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Xiao-yan JIANG1, Hong ZHANG2, Hu CHEN3, Jian LI1
Chinese Journal of Clinical Pharmacology | 2025, 41(9) : 1315 - 1318
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Chinese Journal of Clinical Pharmacology | 2025, 41(9): 1315-1318
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Preliminary exploration of the construction of a qualification evaluation system for primary investigators in clinical trials based on the Delphi method
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Xiao-yan JIANG1, Hong ZHANG2, Hu CHEN3, Jian LI1
Affiliations
  • 1.Clinical Trial Research Centre, The Second Affiliated Hospital of Nanchang University, Nanchang 330006, Jiangxi Province, China
  • 2.Clinical Research Centre, Jiangxi Provincial Cancer Hospital, Nanchang 330006, Jiangxi Province, China
  • 3.Medical Department, Cangzhou Central Hospital, Cangzhou 061001, Hebei Province, China
Published: 2025-05-17 doi: 10.13699/j.cnki.1001-6821.2025.09.020
Outline
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Objective

To establish a qualification evaluation system for primary investigators (PI) in clinical trials.

Methods

Based on the preliminary determination of PI qualification evaluation indicators in accordance with laws and regulations, 19 experts engaged in clinical trials or clinical trial management fields were selected for 2 rounds of Delphi expert consultation, and the weights of each indicator were calculated using principal component analysis.

Results

The positive coefficients for the two rounds of expert consultation were 100.00% and 94.74%, and the expert authority coefficients were 0.940 and 0.933, the coordination coefficients of expert opinions were 0.318 and 0.613. After 2 rounds of expert consultation, the PI qualification evaluation indicators were determined, including 3 primary indicators and 17 secondary indicators. The results of principal component analysis showed that the weight range of each index was 0.037 9 to 0.080 3.

Conclusion

The preliminary construction of the PI qualification evaluation system based on the "PI Qualification Evaluation Form" has strong scientificity and applicability, and can provide references for the evaluation and selection of clinical trial PI.

principal investigator  /  clinical trial  /  evaluation system  /  Delphi method
Xiao-yan JIANG, Hong ZHANG, Hu CHEN, Jian LI. Preliminary exploration of the construction of a qualification evaluation system for primary investigators in clinical trials based on the Delphi method[J]. Chinese Journal of Clinical Pharmacology, 2025 , 41 (9) : 1315 -1318 . DOI: 10.13699/j.cnki.1001-6821.2025.09.020
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Article Info
doi: 10.13699/j.cnki.1001-6821.2025.09.020
  • Receive Date：2024-12-23
  • Online Date：2026-08-04
  • Published：2025-05-17
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History
  • Received：2024-12-23
Funding
Affiliations
    1.Clinical Trial Research Centre, The Second Affiliated Hospital of Nanchang University, Nanchang 330006, Jiangxi Province, China
    2.Clinical Research Centre, Jiangxi Provincial Cancer Hospital, Nanchang 330006, Jiangxi Province, China
    3.Medical Department, Cangzhou Central Hospital, Cangzhou 061001, Hebei Province, China
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https://castjournals.cast.org.cn/joweb/zglcylxzz/EN/10.13699/j.cnki.1001-6821.2025.09.020
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