We are pleased to announce that registration is now open for our next European Workshop kindly hosted by Viedoc Technologies at their premises in Uppsala, Sweden, on 4-6 October 2022.

This hybrid workshop is available for face-to-face or remote participation.
Please note...  Not all of the sessions will be available for remote participation. Remote participation cannot replicate the experience of face-to-face participation and we encourage you to attend in person if you can

REGISTER HERE

This meeting is kindly hosted by Bristol Myers Squibb and held in a facility near the Tokyo Station. 　We are currently accepting suggestions for agenda topics and/or presenters in the areas of  Decentralized Clinical Trials, Digital Health Technologies, Trends in Clinical Research, AI/ML case studies, Regulatory Updates, and Emerging Roles/Responsibilities.

This meeting is kindly hosted by Merck at their Training Facility in North Wales, PA.  We are currently accepting suggestions for agenda topics and/or presenters in the areas of  Decentralized Clinical Trials, Real World Evidence, Digital Health Technologies, Trends in Clinical Research, AI/ML case studies, Regulatory Updates, and Emerging Roles/Responsibilities.

We send a monthly email newsletter to our members to keep them abreast of eCF Views (items on our online members-only discussion board) and eCF News (upcoming events, activities of our project teams, etc). If you would like to be included in the monthly e-newsletter mailing, please send a note to Webmaster3@eclinicalforum.org.   Click "Read More" to see this month's "Views & News"!

We are pleased to announce our next Workshops:

- Europe: Uppsala, Sweden on 4-6 October 2022 kindly hosted by Viedoc Technologies

- Asia-Pacific: Tokyo, Japan on 25-26 October 2022 kindly hosted by Bristol-Myers Squibb

- Americas: North Wales, Pennsylvania on 14-16 November 2022 kindly hosted by Merck & Co.

The workshops will be available for face-to-face and remote participation. We will soon be in touch with registration details but in the meantime please save the dates in your calendar.

We are building exciting agendas for the meetings. If you can contribute or have topics to propose, then please get in touch.

This technology showcase will present how to unlock the value of passive data collection in clinical research by tying the rich, voluminous patient data compiled by mobile sensors and wearables to active mobile measurements.

We will be discussing the general GCP expectations to perform “Quality control” to each stage of trial data handling to ensure that all data are reliable and has been processed correctly. This single statement has very broad interpretations and in this session we can enable the discuss focused the application over Clinical Data Management.

The Regulatory Expert Group is happy to announce the release of the English translation of the JPMA EDC Management Sheet v2.00.  EDC Management Sheet is a tool by which Japan Pharmaceuticals and Medical Devices Agency (PMDA) ensures  the computerized system used in clinical trials comply with relevant regulations and guidelines.This is an unofficial translation and made public for anyone to use. Please be advised that the original Japanese version should be used for any disputes.

Version 2022.1JP1 (10-May-2022)

Japanese translation of eSRA Handbook and Assessment Questionnaire (eSRA日本語訳)

The eClinical Forum is happy to announce the Public release of the "eCF Requirements for Electronic Data for Regulated Clinical Trials PR2021"

ABOUT THE ECF REQUIREMENTS:  The eClinical Forum has produced a set of Requirements, which are based upon statements in regulatory documents that pertain to the design, development, implementation, and management of electronic systems that support clinical research data as well as those statements that pertain to the handling of data that will be used in a regulated clinical trial.  We have reviewed regulatory documents from the FDA, EMA, PMDA, NMPA, MHRA and ICH to produce this set of requirements. Each Requirement has as its basis one or more statements from one or more of these regulatory documents. The Requirements can be used to determine if systems that data which will become part of a regulated clinical trial are consistent with regulatory requirements and if systems and process that manage these data have the necessary features.

Version 2022.2 (25-May-2022; only the license agreement for those re-using in another form has been updated)

This is the ONE FILE that you need to perform an eSRA Assessment.

How to assess site's systems for appropriateness of collecting data for regulated clinical research. (Version 2022)