Academic Journal
The development and analysis of a Japanese modern comprehensive clinical data management training program
| Title: | The development and analysis of a Japanese modern comprehensive clinical data management training program |
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| Authors: | Takuhiro Yamaguchi, Hiroko Yaegashi, Shih-Wei Chiu, Yukari Uemura, Takuya Kawahara, Tempei Miyaji, Tomoe Mashiko, Munenori Takata |
| Source: | Heliyon, Vol 10, Iss 6, Pp e27846- (2024) |
| Publisher Information: | Elsevier, 2024. |
| Publication Year: | 2024 |
| Collection: | LCC:Science (General) LCC:Social sciences (General) |
| Subject Terms: | Clinical data management, Training program, Risk-based monitoring, Clinical Data Interchange Standards Consortium, Science (General), Q1-390, Social sciences (General), H1-99 |
| More Details: | Background: Clinical data management (CDM) collects, integrates, and makes data available. It plays a vital role in clinical research. However, there are few opportunities for Japanese clinical data managers to learn about its systematic framework, particularly in academic research organizations. While Japanese-language CDM training exists, its effectiveness in a Japanese context requires clarification. Objectives: We aimed to develop an advanced program of instruction for professionals to understand CDM and to determine the effectiveness of the training program. Methods and results: We developed an advanced program including risk-based monitoring and the Clinical Data Interchange Standards Consortium on a trial basis for clinical data managers to provide them with a comprehensive understanding of CDM. Fifty-two people attended the program and reported that they were highly satisfied with it. Conclusions: To provide comprehensive CDM training in Japan, it is imperative to continue improving the content and develop an advanced program. Due to the recent tightening of clinical research regulations and the development and dissemination of various systems for conducting clinical research, the competency-based educational program requires further development. |
| Document Type: | article |
| File Description: | electronic resource |
| Language: | English |
| ISSN: | 2405-8440 |
| Relation: | http://www.sciencedirect.com/science/article/pii/S2405844024038775; https://doaj.org/toc/2405-8440 |
| DOI: | 10.1016/j.heliyon.2024.e27846 |
| Access URL: | https://doaj.org/article/d8ed5d858f744b78989831899254ac7e |
| Accession Number: | edsdoj.8ed5d858f744b78989831899254ac7e |
| Database: | Directory of Open Access Journals |
| ISSN: | 24058440 |
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| DOI: | 10.1016/j.heliyon.2024.e27846 |
| Published in: | Heliyon |
| Language: | English |