Evidence map›Paper›PMID 38545152›Full record

ArticleHeliyon2024

The development and analysis of a Japanese modern comprehensive clinical data management training program.

Takuhiro Yamaguchi, Hiroko Yaegashi, Shih-Wei Chiu, Yukari Uemura, Takuya Kawahara, Tempei Miyaji, Tomoe Mashiko, Munenori Takata

Open access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Heliyon, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
0.5field-weighted citation impact, top 34% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed, 1 citations in OpenAlex.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 4 institutions in 1 country.

Takuhiro YamaguchiClinical Research Data Center, Tohoku University Hospital, Japan.
Hiroko YaegashiDivision of Biostatistics, Tohoku University Graduate School of Medicine, Japan.
Shih-Wei ChiuClinical Research Data Center, Tohoku University Hospital, Japan.
Yukari UemuraCenter for Clinical Sciences, National Center for Global Health and Medicine, Japan.
Takuya KawaharaClinical Research Promotion Center, The University of Tokyo Hospital, Japan.
Tempei MiyajiDepartment of Clinical Trial Data Management, Graduate School of Medicine, The University of Tokyo, Japan.
Tomoe MashikoSuxac Inc., Japan.
Munenori TakataClinical Research Data Center, Tohoku University Hospital, Japan.
Tohoku University · JPNational Center for Global Health and Medicine · JPThe University of Tokyo · JPUniversity of Tokyo Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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.

Indexed as

Clinical Data Interchange Standards ConsortiumClinical data managementRisk-based monitoringTraining program

Identifiers

PMID38545152
PMCPMC10966602
OpenAlexW4392868830

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.