WHO WE ARE

The eClinical Forum is a global network of peers. It provides a non‐competitive environment for innovation, learning and collaboration in clinical research.

 

NEWS FROM THE ECF

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。

Print
Tags:
Rate this article:
No rating

NOT A MEMBER?

Visit the Membership page to learn 
How To Become a Member
(Join the eClinical Forum and learn how to leverage existing and emerging technologies for electronic clinical trials. Access an eClinical community, member-only knowledge, events and forums)
«July 2024»
MonTueWedThuFriSatSun
242526
eCF Birds-of-a-Feather Webinar:  Site experience in the day-and-age of hybrid e-trials

eCF Birds-of-a-Feather Webinar:  Site experience in the day-and-age of hybrid e-trials

Back by popular demand!  Dr. van de Walle presented at the hybrid European eCF workshop in May … and we just ran out of time to answer all the questions! So many requests to ask Viviënne to present again with more time. So, here it is! Not to be missed!  Viviënne is a full-time investigator and founder of an indepenent research site. She has vast site and patient experience and will share her insight into how hybrid trials are going for the sites and the patients.

Read more
27282930
12
eCF Views & News

eCF Views & News

We send out a brief monthly newsletter via email to all our active eCF members to keep them abreast of the activities of eCF that they can participate in. The more who participate, the better we are "A Network Powered by Peers". Click to see the most current newsletter.

Read more
345
2024 Members Release of the "Requirements for Electronic Data for Regulated Clinical Trials" (commonly referred to as the “eCF Requirements”)

2024 Members Release of the "Requirements for Electronic Data for Regulated Clinical Trials" (commonly referred to as the “eCF Requirements”)

The "eCF Requirements" Members Release V2024 has been released.  This is a significant accomplishment by the eClinical Forum’s “Regulatory Expert Group” (REG) as they have put in countless hours over many years to be able to produce such a comprehensive list of compliance requirements for  electronic systems that will manage data used in regulated clinical research, against regulations and guidances from 40 different documents from FDA, EMA, PMDA, NMPA, MHRA and ICH and ISO.

Read more
67
891011121314
15
Public release of the "Requirements for Electronic Data for Regulated Clinical Trials" (commonly referred to as the “eCF Requirements”)

Public release of the "Requirements for Electronic Data for Regulated Clinical Trials" (commonly referred to as the “eCF Requirements”)

The eClinical Forum is releasing its 7th public version of the “eCF Requirements” which takes all of the requirements and guidance directions that pertain to electronic data and electronic systems that support clinical research, from FDA, EMA, PMDA, MNPA, MHRA and ICH , and boils them down into 37 unique statements or "eCF Requirements".

Read more
161718
eCF Birds-of-a-Feather Webinar:  Protocol Optimization using AI/ML

eCF Birds-of-a-Feather Webinar:  Protocol Optimization using AI/ML

We will be discussing the transformative potential of Artificial Intelligence (AI) and Generative AI in clinical development.

Read more
192021
22232425262728
2930311234

Upcoming events Events RSSiCalendar export