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eSRA was used in a Japanese research paper on data quality of medical information systems

Japan Society for Medical Informatics

eSRA was used in a Japanese research paper on data quality of medical information systems

Professor Yokoi of the Medical Information Department of Kagawa University Hospital, who is well-known in the field of medical information, Associate Professor Dr. Tanigawa, and Dr. Aoyagi, Director of National Cancer Center East Hospital, and eClinical Forum have been conducting research to evaluate the data quality of electronic records requirements in Japan Ministry of Health, Labour and Welfare's "Guideline on security management for medical information systems",  against pharmaceutical regulations and guidelines on computerized systems, using eClinical Forum’s eSource Readiness Assessment (eSRA), and to discuss the identified gaps.  The research result is published in an article of Medical Informatics Vol. 41 No. 3 of the Japan Society for Medical Informatics: The Pharmaceutical Regulatory Compliance of Electronic Records in Medical Information Systems―Quality Managements for Computerized System.

医療情報の分野でご高名な香川大学医学部附属病院医療情報部の横井教授をはじめ、谷川特命准教授、国立がんセンター東病院の青柳室長とともに、厚生労働省の「医療情報システムの安全管理に関するガイドライン」で求められている医療情報システムの電磁的記録のデータ品質を、eClinical Forum のeSRA(注) を用いて,医薬品等の承認申請に係るコンピュータ化システムに対して適用される薬事規制およびガイドラインに照らして分析し、その結果を考察する研究を進めてきましたが、このたびその成果が日本医療情報学会の医療情報学 Vol. 41 No. 3 の解説記事 「医療情報システム」における電磁的記録の薬事利用への対応 ―コンピュータ化システムの品質マネジメント―」に掲載されました。

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eCF Webinar: Trial Master File Archiving and the Decommissioning of Computerised Systems Used in Clinical Trials.

eCF Webinar: Trial Master File Archiving and the Decommissioning of Computerised Systems Used in Clinical Trials.

We will be discussing a recent eCF/EUCROF positions paper: 

The full history of a clinical trial describes the conduct of the trial and the quality of the data produced. Changes in technology and the evolution of regulatory expectations on electronic systems over the past two decades have resulted in a situation where additional supplementary documentation is needed to reconstruct some clinical trial activities. Many of the computerised systems used during a trial are only used during the active trial data collection stage. This period of use is shorter than the retention period required for the archiving of the essential documents of the trial. Furthermore, the documentation that makes up this history is distributed between sponsor, investigators and vendors. Data is stored locally, in the cloud, on patient devices, at vendors, and sub-vendors. Where the data is archived (sponsor, investigator, vendor), in what format (kept live or static), and for how long are issues discussed in the position paper.  You can download the position paper here: Position Paper: Trial Master File Archiving and the Decommissioning of Computerised Systems Used in Clinical Trials, PR1 (eclinicalforum.org)

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eCF Round-table: Electronic Investigator Site Files (eISF)

eCF Round-table: Electronic Investigator Site Files (eISF)

This is a round-table discussion. Participants are encouraged to share experiences, make comments, ask questions, and contribute to the discussion. We will be discussing challenges Sponsor companies are having evaluating, monitoring and documenting a site’s eISF, and to share best practices, challenges, and ideas. 

Facilitators:   Ronit Elstein (Pfizer, US) Martijn Griep (Janssen, Belgium)

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eCF Round-table: Electronic Investigator Site Files (eISF)

eCF Round-table: Electronic Investigator Site Files (eISF)

This is a round-table discussion. Participants are encouraged to share experiences, make comments, ask questions, and contribute to the discussion. We will be discussing challenges Sponsor companies are having evaluating, monitoring and documenting a site’s eISF, and to share best practices, challenges, and ideas. 

Facilitators:   Ronit Elstein (Pfizer, US) Martijn Griep (Janssen, Belgium)

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