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

eCF Webinar on "eCF Requirements" and "eSRA" - Recording Available Here

Requirements for Regulated Electronic Data in Clinical Trials and the Site eSource-Readiness Assessment

eCF Webinar on "eCF Requirements" and "eSRA" - Recording Available Here

The eClinical Forum is pleased to offer a recording of our free public webinar – the same as was presented to the FDA CDER Health IT Board on 6-April-2021 – to provide information on our 2 free tools: The “eCF Requirements” (Requirements for electronic data for regulated clinical trials) and eSRA (Site eSource-Readiness Assessment).This public webinar was given on 28-April-2021 to over 250 registrants worldwide. 

eCF "Birds-of-a-Feather" Round-table Discussions and Technology Showcases 2020 to 2021

Select recordings available

eCF "Birds-of-a-Feather" Round-table Discussions and Technology Showcases 2020 to 2021

“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.

eCF Free Public Webinar: Requirements for Electronic Data for Regulated Clinical Trials, and associated Investigator Site eSource-Readiness Assessment

Wed, 28-April-2021 -- webinar offered at 2 times

eCF Free Public Webinar: Requirements for Electronic Data for Regulated Clinical Trials, and associated Investigator Site eSource-Readiness Assessment

The eClinical Forum is pleased to offer a free public webinar – the same as was presented to the FDA CDER Health IT Board on 6-April-2021 – to provide information on our 2 free tools: The “eCF Requirements” (Requirements for electronic data for regulated clinical trials) and eSRA (Site eSource-Readiness Assessment).

Implementing eSRA: Sponsor Perspective

Implementing eSRA: Sponsor Perspective

How to assess site's systems for appropriateness of collecting data for regulated clinical research. (Version 2021)

eCF Requirements for Electronic Data for Regulated Clinical Trials PR2020

eCF Requirements for Electronic Data for Regulated Clinical Trials PR2020

The eClinical Forum is happy to announce the Public release of the "eCF Requirements for Electronic Data for Regulated Clinical Trials PR2020"

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 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.

Birds-of-a-Feather Round Table Discussion: “When does audit trail begin?”

Tuesday, 16-March-2021 at UTC 08:00 and UTC 16:00

Birds-of-a-Feather Round Table Discussion:  “When does audit trail begin?”

Audit trails create a step-by-step record of data back to its source. It is utilized when the integrity and confidence of the datapoint has critical/legal significance. It is important to determine and declare when data entry becomes “real” data. In legacy paper, data is manually recorded, but only becomes “real” when it is signed, submitted, or completed. Signatures and confirmations also exist to add additional credibility to the source. If a paper form is being filled, it is considered draft until it is declared complete by the originator. The originator has the option to crumple up the “draft” paper and start another without question. The same should hold true with electronic data entry as this webinar will discuss.

BoF Round-table Discussion: Considerations and challenges for electronic research data archival at sites using direct download

Wed, 24-Feb-2021 at UTC 0800 or UTC 1600

BoF Round-table Discussion: Considerations and challenges for electronic research data archival at sites using direct download

The implementation of new solutions to share electronically the eCRF PDFs with sites have brought up new considerations and challenges to this process.

We would like everyone to share their experiences on how the process has been implemented, as well as the challenges experienced. This will be a group discussion on the recommendations to make this process as straight forward as possible for Sites and Sponsors, while complying with requirements.

Facilitated by Carmen Jiménez, Eli Lilly

BoF Webinar: IMI Mobilise-D -- Measuring and validating real-world mobility – Easier said than done

Tues, 10 Nov 2020

BoF Webinar: IMI Mobilise-D -- Measuring and validating real-world mobility – Easier said than done

Date:  Tuesday 10-November, 2020  Duration: One hour  Time: UTC 1500

Presenter:   Beatrix Vereijken (Norwegian University of Science and Technology) and Valdo Arnera (ERT Technology)

Mobility is an important marker of health, key to our independence, and a major driver for quality of life. Many aspects of how we walk can be easily measured and quantified in a well-equipped scientific or clinical laboratory, but this ‘artificial snapshot in time’ is a poor indicator of how well we move about in the real world. Recent advances in digital technologies have opened the door to monitoring mobility 24/7 but going beyond the number of steps or the vigour of moving has shown remarkably difficult. Yet, accurate assessment of daily life mobility in clinical trials and patient treatment is necessary for improved and more personalised care, but what is required to get there?

REGISTRATIONS CLOSED: eClinical Forum Virtual Workshop, 12-16 October 2020

Better Together

REGISTRATIONS CLOSED: eClinical Forum Virtual Workshop, 12-16 October 2020

We are pleased to announce the details of our next Virtual Global Workshop on 12-16 October 2020 (which replaces our planned Global Workshop in Dublin which is postponed until 2021). The virtual workshop will include a mix of global and regional events and is open to participants from any member company in any region.

Our last virtual workshop was a great success and this one will be even better. We have made sure that sessions are as convenient as possible for the different timezones across the world by limiting the duration of global sessions and offering more regional sessions. Learning from each other is what we do best and we will be introducing a number of ways to increase interactivity during the workshop (although nothing can replace the networking and comeraderie of an eCF face-to-face meeting!). REGISTER HERE

Birds-of-a-Feather Webinar: Real-world data (RWD) and real-world evidence (RWE)

Recording of 8-July-2020 webinar available!

Birds-of-a-Feather Webinar: Real-world data (RWD) and real-world evidence (RWE)

According to the FDA’s website, “Real-world data (RWD) and real-world evidence (RWE) are playing an increasing role in health care decisions.”  And a recent survey by the eClinical Forum showed that most respondents believe that RWD and RWE will become much more important in clinical research over the next few years.  As a result, many questions have arisen regarding the use cases, data sources, quality of these sources, regulatory guidance documents and so on. The goal of this “Birds of a Feather” session is to present some basic information on these topics and to present a few case examples to illustrate how RWD and RWE are playing an increasingly important role in research. 

Birds-of-a-Feather Round Table Discussion: U.S. National Patient Identifier (NPI) and its Impact to Clinical Trials

August 18, 2020

Birds-of-a-Feather Round Table Discussion:  U.S. National Patient Identifier (NPI) and its Impact to Clinical Trials

Presenter/Facilitator:  Ken Light, Clinscape

In 1996, HIPAA legislation called for the development of a national patient identifier system that would give each person in the United States a permanently assigned, unique number to be used across the entire spectrum of the national healthcare system.   That project was never funded by congress, but just last year (June, 2019) Congress voted to appropriate $99 billion dollars to an HHS bill that included creation of a National Patient Identifier.

Ken will review this topic, and oversee a group dialog around the benefits, challenges, and impact related to healthcare and clinical trials.   

Technology Showcase: eClinical Solutions -- Automating the Clinical Data Pipeline for Enhanced Data Review & Analytics

Thursday 23 July 2020

Technology Showcase: eClinical Solutions -- Automating the Clinical Data Pipeline for Enhanced Data Review & Analytics

There has been a dramatic increase in clinical data types, sources and systems in recent years enabling new insights into patient experiences while also presenting challenges in consolidating, standardizing and analyzing these new data streams.  The tools for centralizing, integrating, mapping and analyzing data have not kept pace with research and are causing cycle time delays and require numerous manual processes.  This technology showcase will describe how new platforms like the elluminate Clinical Data Platform are automating the ingestion of data from numerous eClinical systems and sources, enabling faster data mapping and standardization, supporting risk based data review and advancing both clinical and operational analytics.  

Presented by Sheila Rocchio and Sam Parnell of eClinical Solutions.

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eCF Free Public Webinar: Requirements for Electronic Data for Regulated Clinical Trials, and associated Investigator Site eSource-Readiness Assessment

eCF Free Public Webinar: Requirements for Electronic Data for Regulated Clinical Trials, and associated Investigator Site eSource-Readiness Assessment

The eClinical Forum is pleased to offer a free public webinar – the same as was presented to the FDA CDER Health IT Board on 6-April-2021 – to provide information on our 2 free tools: The “eCF Requirements” (Requirements for electronic data for regulated clinical trials) and eSRA (Site eSource-Readiness Assessment).

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REGISTRATION IS OPEN: eClinical Forum Virtual Spring Workshop, 4-18 May 2021

REGISTRATION IS OPEN: eClinical Forum Virtual Spring Workshop, 4-18 May 2021

We are pleased to announce the details of our next Virtual Global Workshop on 4-18 May 2021. The virtual workshop will include presentation, discussion and working sessions and is open to participants from any member company in any region.

Our virtual workshops in 2020 were a great success and this one will be even better! We have made sure that sessions are as convenient as possible for the different timezones across the world by limiting the duration of sessions and offering more regional sessions. Learning from each other is what we do best and we will be introducing a number of ways to increase interactivity during the workshop (although nothing can replace the networking and comeraderie of an eCF face-to-face meeting!). REGISTER HERE

Read more
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REGISTRATION IS OPEN: eClinical Forum Virtual Spring Workshop, 4-18 May 2021

REGISTRATION IS OPEN: eClinical Forum Virtual Spring Workshop, 4-18 May 2021

We are pleased to announce the details of our next Virtual Global Workshop on 4-18 May 2021. The virtual workshop will include presentation, discussion and working sessions and is open to participants from any member company in any region.

Our virtual workshops in 2020 were a great success and this one will be even better! We have made sure that sessions are as convenient as possible for the different timezones across the world by limiting the duration of sessions and offering more regional sessions. Learning from each other is what we do best and we will be introducing a number of ways to increase interactivity during the workshop (although nothing can replace the networking and comeraderie of an eCF face-to-face meeting!). REGISTER HERE

Read more
7
REGISTRATION IS OPEN: eClinical Forum Virtual Spring Workshop, 4-18 May 2021

REGISTRATION IS OPEN: eClinical Forum Virtual Spring Workshop, 4-18 May 2021

We are pleased to announce the details of our next Virtual Global Workshop on 4-18 May 2021. The virtual workshop will include presentation, discussion and working sessions and is open to participants from any member company in any region.

Our virtual workshops in 2020 were a great success and this one will be even better! We have made sure that sessions are as convenient as possible for the different timezones across the world by limiting the duration of sessions and offering more regional sessions. Learning from each other is what we do best and we will be introducing a number of ways to increase interactivity during the workshop (although nothing can replace the networking and comeraderie of an eCF face-to-face meeting!). REGISTER HERE

Read more
8
REGISTRATION IS OPEN: eClinical Forum Virtual Spring Workshop, 4-18 May 2021

REGISTRATION IS OPEN: eClinical Forum Virtual Spring Workshop, 4-18 May 2021

We are pleased to announce the details of our next Virtual Global Workshop on 4-18 May 2021. The virtual workshop will include presentation, discussion and working sessions and is open to participants from any member company in any region.

Our virtual workshops in 2020 were a great success and this one will be even better! We have made sure that sessions are as convenient as possible for the different timezones across the world by limiting the duration of sessions and offering more regional sessions. Learning from each other is what we do best and we will be introducing a number of ways to increase interactivity during the workshop (although nothing can replace the networking and comeraderie of an eCF face-to-face meeting!). REGISTER HERE

Read more
9
REGISTRATION IS OPEN: eClinical Forum Virtual Spring Workshop, 4-18 May 2021

REGISTRATION IS OPEN: eClinical Forum Virtual Spring Workshop, 4-18 May 2021

We are pleased to announce the details of our next Virtual Global Workshop on 4-18 May 2021. The virtual workshop will include presentation, discussion and working sessions and is open to participants from any member company in any region.

Our virtual workshops in 2020 were a great success and this one will be even better! We have made sure that sessions are as convenient as possible for the different timezones across the world by limiting the duration of sessions and offering more regional sessions. Learning from each other is what we do best and we will be introducing a number of ways to increase interactivity during the workshop (although nothing can replace the networking and comeraderie of an eCF face-to-face meeting!). REGISTER HERE

Read more
10
REGISTRATION IS OPEN: eClinical Forum Virtual Spring Workshop, 4-18 May 2021

REGISTRATION IS OPEN: eClinical Forum Virtual Spring Workshop, 4-18 May 2021

We are pleased to announce the details of our next Virtual Global Workshop on 4-18 May 2021. The virtual workshop will include presentation, discussion and working sessions and is open to participants from any member company in any region.

Our virtual workshops in 2020 were a great success and this one will be even better! We have made sure that sessions are as convenient as possible for the different timezones across the world by limiting the duration of sessions and offering more regional sessions. Learning from each other is what we do best and we will be introducing a number of ways to increase interactivity during the workshop (although nothing can replace the networking and comeraderie of an eCF face-to-face meeting!). REGISTER HERE

Read more
11
REGISTRATION IS OPEN: eClinical Forum Virtual Spring Workshop, 4-18 May 2021

REGISTRATION IS OPEN: eClinical Forum Virtual Spring Workshop, 4-18 May 2021

We are pleased to announce the details of our next Virtual Global Workshop on 4-18 May 2021. The virtual workshop will include presentation, discussion and working sessions and is open to participants from any member company in any region.

Our virtual workshops in 2020 were a great success and this one will be even better! We have made sure that sessions are as convenient as possible for the different timezones across the world by limiting the duration of sessions and offering more regional sessions. Learning from each other is what we do best and we will be introducing a number of ways to increase interactivity during the workshop (although nothing can replace the networking and comeraderie of an eCF face-to-face meeting!). REGISTER HERE

Read more
12
REGISTRATION IS OPEN: eClinical Forum Virtual Spring Workshop, 4-18 May 2021

REGISTRATION IS OPEN: eClinical Forum Virtual Spring Workshop, 4-18 May 2021

We are pleased to announce the details of our next Virtual Global Workshop on 4-18 May 2021. The virtual workshop will include presentation, discussion and working sessions and is open to participants from any member company in any region.

Our virtual workshops in 2020 were a great success and this one will be even better! We have made sure that sessions are as convenient as possible for the different timezones across the world by limiting the duration of sessions and offering more regional sessions. Learning from each other is what we do best and we will be introducing a number of ways to increase interactivity during the workshop (although nothing can replace the networking and comeraderie of an eCF face-to-face meeting!). REGISTER HERE

Read more
13
REGISTRATION IS OPEN: eClinical Forum Virtual Spring Workshop, 4-18 May 2021

REGISTRATION IS OPEN: eClinical Forum Virtual Spring Workshop, 4-18 May 2021

We are pleased to announce the details of our next Virtual Global Workshop on 4-18 May 2021. The virtual workshop will include presentation, discussion and working sessions and is open to participants from any member company in any region.

Our virtual workshops in 2020 were a great success and this one will be even better! We have made sure that sessions are as convenient as possible for the different timezones across the world by limiting the duration of sessions and offering more regional sessions. Learning from each other is what we do best and we will be introducing a number of ways to increase interactivity during the workshop (although nothing can replace the networking and comeraderie of an eCF face-to-face meeting!). REGISTER HERE

Read more
14
REGISTRATION IS OPEN: eClinical Forum Virtual Spring Workshop, 4-18 May 2021

REGISTRATION IS OPEN: eClinical Forum Virtual Spring Workshop, 4-18 May 2021

We are pleased to announce the details of our next Virtual Global Workshop on 4-18 May 2021. The virtual workshop will include presentation, discussion and working sessions and is open to participants from any member company in any region.

Our virtual workshops in 2020 were a great success and this one will be even better! We have made sure that sessions are as convenient as possible for the different timezones across the world by limiting the duration of sessions and offering more regional sessions. Learning from each other is what we do best and we will be introducing a number of ways to increase interactivity during the workshop (although nothing can replace the networking and comeraderie of an eCF face-to-face meeting!). REGISTER HERE

Read more
15
REGISTRATION IS OPEN: eClinical Forum Virtual Spring Workshop, 4-18 May 2021

REGISTRATION IS OPEN: eClinical Forum Virtual Spring Workshop, 4-18 May 2021

We are pleased to announce the details of our next Virtual Global Workshop on 4-18 May 2021. The virtual workshop will include presentation, discussion and working sessions and is open to participants from any member company in any region.

Our virtual workshops in 2020 were a great success and this one will be even better! We have made sure that sessions are as convenient as possible for the different timezones across the world by limiting the duration of sessions and offering more regional sessions. Learning from each other is what we do best and we will be introducing a number of ways to increase interactivity during the workshop (although nothing can replace the networking and comeraderie of an eCF face-to-face meeting!). REGISTER HERE

Read more
16
REGISTRATION IS OPEN: eClinical Forum Virtual Spring Workshop, 4-18 May 2021

REGISTRATION IS OPEN: eClinical Forum Virtual Spring Workshop, 4-18 May 2021

We are pleased to announce the details of our next Virtual Global Workshop on 4-18 May 2021. The virtual workshop will include presentation, discussion and working sessions and is open to participants from any member company in any region.

Our virtual workshops in 2020 were a great success and this one will be even better! We have made sure that sessions are as convenient as possible for the different timezones across the world by limiting the duration of sessions and offering more regional sessions. Learning from each other is what we do best and we will be introducing a number of ways to increase interactivity during the workshop (although nothing can replace the networking and comeraderie of an eCF face-to-face meeting!). REGISTER HERE

Read more
17
REGISTRATION IS OPEN: eClinical Forum Virtual Spring Workshop, 4-18 May 2021

REGISTRATION IS OPEN: eClinical Forum Virtual Spring Workshop, 4-18 May 2021

We are pleased to announce the details of our next Virtual Global Workshop on 4-18 May 2021. The virtual workshop will include presentation, discussion and working sessions and is open to participants from any member company in any region.

Our virtual workshops in 2020 were a great success and this one will be even better! We have made sure that sessions are as convenient as possible for the different timezones across the world by limiting the duration of sessions and offering more regional sessions. Learning from each other is what we do best and we will be introducing a number of ways to increase interactivity during the workshop (although nothing can replace the networking and comeraderie of an eCF face-to-face meeting!). REGISTER HERE

Read more
18
REGISTRATION IS OPEN: eClinical Forum Virtual Spring Workshop, 4-18 May 2021

REGISTRATION IS OPEN: eClinical Forum Virtual Spring Workshop, 4-18 May 2021

We are pleased to announce the details of our next Virtual Global Workshop on 4-18 May 2021. The virtual workshop will include presentation, discussion and working sessions and is open to participants from any member company in any region.

Our virtual workshops in 2020 were a great success and this one will be even better! We have made sure that sessions are as convenient as possible for the different timezones across the world by limiting the duration of sessions and offering more regional sessions. Learning from each other is what we do best and we will be introducing a number of ways to increase interactivity during the workshop (although nothing can replace the networking and comeraderie of an eCF face-to-face meeting!). REGISTER HERE

Read more
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