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

e-Investigator Site File Questionnaire (eISFQ)

e-Investigator Site File Questionnaire (eISFQ)

Developing a questionnaire to assist sites in evaluating their e-Investigator Site File systems against clinical research regulatory regulations and recommendations.

eCF "Birds-of-a-Feather" Round-table Discussions, Presentations and Technology Showcases 2020 to 2022

Select recordings available

eCF "Birds-of-a-Feather" Round-table Discussions, Presentations and Technology Showcases 2020 to 2022

“Birds-of-a-Feather” Webinars are provided monthly, to get those with similar interests together.  Anyone from an eCF member company (around the globe!) can participate, gratis. All eCF members can suggest a topic and/or lead a discussion.

Agenda Available: eClinical Forum Americas Workshop

14-16 November 2022

Agenda Available: eClinical Forum Americas Workshop

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.

Views & News -- October 2022

eCF's monthly e-newsletter - “Keeping you Current”

Views & News -- October 2022

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"!

eCF Technology Showcase: Clinical ink - "Tying Passive Data Collection to Active Mobile Measurements"

Wed, 7-Sep-22 at UTC 1400

eCF Technology Showcase: Clinical ink - "Tying Passive Data Collection to Active Mobile Measurements"

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.

eCF Focus Session on "Using RWD and RWE in Clinical Trials"

Wed, 13-July-2022 at UTC 1400

eCF Focus Session on "Using RWD and RWE in Clinical Trials"

This is a Panel Discussion "Using RWD and RWE in Clinical Trials" - Explore challenges and opportunities to leverage real world data to accelerate and optimize clinical trial decision making.

Birds-of-a-Feather Round Table Discussion: Measuring Clinical Trial Data Quality

Wednesday, 10-Aug-2 at UTC 1400

Birds-of-a-Feather Round Table Discussion:  Measuring Clinical Trial Data Quality

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.

REGISTRATION OPEN: eClinical Forum Hybrid Workshop, New Jersey June 8-10 2022

Old York Cellars Winery, Ringoes New Jersey USA

REGISTRATION OPEN: eClinical Forum Hybrid Workshop, New Jersey June 8-10 2022

We are pleased to announce that registration is open for our hybrid workshop at the Old York Cellars in Ringoes, NJ on June 8-10 2022. We are very excited that we can offer this safe and fun venue as we will be meeting in an open-air event tent amidst their beautiful vineyard. Learning from each other is what we do best, and the workshop will provide opportunity for collaboration and exchange, contribution to the work of the eClinical Forum, round table discussions on hot topics and time for Q&A as well as evening networking events.  For those who cannot join in person, some of the sessions will be live-streamed and recorded.

eCF Requirements for Electronic Data for Regulated Clinical Trials PR2021

4-April-2022

eCF Requirements for Electronic Data for Regulated Clinical Trials PR2021

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.

Implementing eSRA: Sponsor Perspective

Implementing eSRA: Sponsor Perspective

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

Difference between eSRA V2022 and eSRA V2021

Difference between eSRA V2022 and eSRA V2021

eCF BoF Webinar: Principal Investigator's Signature: Best Practices

Wed, 27-April-2022

eCF BoF Webinar: Principal Investigator's Signature: Best Practices

 The eCF’s PI Signature Working Group have updated their 3-year-old document which is released to eCF Members in early April.  They will introduce the 2022 changes to the best practice document for Investigator’s signature on electronic Case Report Forms (eCRFs).  Participants are encouraged to share their thoughts on:

- how to provide continuous monitoring of regulatory expectations;

- sharing members’ experience on implementation and regulatory findings (if any);

- brainstorming for an industry definition of the “meaning” of signature on data reported to sponsors during both traditional and non-traditional clinical trials.

Presenters:   eCF PI Signature Team Leaders:  Cinzia Piccinia (Eli Lilly) and Babette von Hagen (CSL Behring)

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