en-USen-GB
  • Virtual Workshop 12-16 October 2020
    Virtual Workshop 12-16 October 2020
  • Virtual Global Workshop 11-13 May 2020
    Virtual Global Workshop 11-13 May 2020
  • Tokyo 2-3 December 2019
    Tokyo 2-3 December 2019
  • Zurich 28-30 October 2019
    Zurich 28-30 October 2019
  • Peapack 14-16 October 2019
    Peapack 14-16 October 2019
  • Brussels 15-17 May 2019
    Brussels 15-17 May 2019
  • Danbury 8-10 April 2019
    Danbury 8-10 April 2019

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

Login to also view news for Members.

Birds-of-a-Feather Webinar: Tufts-eClinical Solutions "Data Strategy and Transformation Study Results"

Thursday April 30 2020

Birds-of-a-Feather Webinar:  Tufts-eClinical Solutions "Data Strategy and Transformation Study Results"

eClinical Solutions, a member of the eClinical Forum, has collaborated with the Tufts Center for the Study of Drug Development in 2019 to survey pharmaceutical companies about their evolving clinical data demands and the tactics they are employing to manage and leverage their data. Highlights reveal new strategies and digital transformation initiatives being taken. This webinar will share key results from the survey as well as insights and opportunities to use this data to further clinical data architectures. 

Birds-of-a-Feather Round-Table Webinar Discussion: Subject Status Calculations

Date: Tuesday, April 21 2020 Duration: One hour

Birds-of-a-Feather Round-Table Webinar Discussion:  Subject Status Calculations

Facilitator: Lisa Jones-Moore, Clinical Systems & Supplies Planning, Eli Lilly & Co.

This is a round-table discussion and participants are encouraged to share their experiences, ideas and questions on this topic.

The following questions will be discussed:

  • How many subject/patient dispositions do you collect (i.e. Subject completed treatment and follow-up, Subject discontinued treatment and dropped follow-up, Subject discontinued treatment and completed follow-up, etc.)
  • How does subject status get updated in your clinical trial management system?  Automated calculation using a datahub or manual update by monitoring or other personnel?
  • Is monitoring done internally or is there a third party organization performing this task?  If TPO, do they use their own system or your system?  If they use their own system, how does the data get back into your system?

eClinical Forum announces Public Release of "Requirements for Electronic Data for Regulated Clinical Trials"

V2019PR March 2020

eClinical Forum announces Public Release of "Requirements for Electronic Data for Regulated Clinical Trials"

The eClinical Forum is happy to announce the Public release of the “eCF Requirements V2019PR”.

ABOUT THE ECF REQUIREMENTSThe 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, 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.

eCF Webinar: Industry Standard HL7 FHIR as used to integrate Sponsor’s EDC system with Site’s EHR System

March 24 2020

eCF Webinar: Industry Standard HL7 FHIR as used to integrate Sponsor’s EDC system with Site’s EHR System

This presentation will focus on how to reduce the amount of manual data entry for Site users by leveraging Health Level 7 (HL7) Fast Health Interoperable Resources (FHIR) standard.  Some sponsors are using FHIR to automate data entry of the EDC System’s Case Report Forms by integrating with their Site’s EHR System. This is an exciting trend that is in very early stages of adoption across the industry. We will hear from a site regarding how they send data (local labs, vitals, demographics, EKG, etc. ) directly to their sponsors and CROs via data file extracts and FHIR. We will hear from a technology vendor who has adopted the FHIR standard.

Free Public Webinar: Sponsor responsibility to Assess Investigator Site Systems that may originate source for clinical trials & the free eSRA tool

Offered 2 times on either Feb 25 or Feb 26 2020

Free Public Webinar: Sponsor responsibility to Assess Investigator Site Systems that may originate source for clinical trials & the free eSRA tool

Presenter:  Kelley Olree, Study Manager – Pfizer, and eClinical Forum eSRA Team

This webinar will discuss:

  • What the Sponsor’s responsibility is regarding using data that has originated in an Investigator Site system (Electronic Health Records (EHR) or Electronic Medical Records (EMR) according to different health authorities
  • Benefits of all sites and all sponsors and all CROs using a common assessment tool
  • The eClinical Forum, a non-profit, non-commercial discussion/action group comprised of members of the Pharmaceutical and Clinical Research Services industry, along with sites and academia, have developed a regulatory-based assessment tool for clinical research sites to determine if their computer system (EHR, EMR, etc) is appropriate to hold regulated clinical trial data. It has been available for free for over 4 years and is currently being used around the globe by many sponsors and thousands of sites.
  • The eClinical Forum’s free “eSource-Readiness Assessment” (eSRA) that assists the sponsor/site in determining if the site system is appropriate for sourcing clinical research records
  • How a Sponsor/CRO can incorporate eSRA into their processes
RSS
135678910Last

Theme picker

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)

«September 2020»
MonTueWedThuFriSatSun
31123456
789
9/9/2020 UTC
108

Free Public Webinar: Assessment of Investigator Site Systems that may originate source for clinical trials & the free eSRA tool (Japanese)

eSRA (eSource Readiness Assessment) is a tool to assess the data that has originated in an Investigator Site system (Electronic Health Records (EHR) or Electronic Medical Records (EMR) according to different health authorities. eClinical Forum issued a Japanese translation of eSRA Handbook in July.  This seminar is targeted for Japanese audiences, and eSRA will be explained in Japanese.
eSRA (eSource Readiness Assessment)はEHR/EMRなどの医療機関のシステムのデータを治験に利用できるかどうか評価するためのツールであり、7月にeSRA Handbookの日本語版がリリースされました。本Webinarは日本の方を対象にeSRAをご紹介するものです。ぜひご参加をお待ちしています。

Read more
10111213
14151617181920
212223
9/23/2020 UTC
109

BoF Webinar: The Use of Audit Trail Review as a Key Tool in Ensuring Data Integrity

Join us for a discussion of the eCF/SCDM industry position paper on the use of audit trail review as a key tool in ensuring data integrity.   We will share our thoughts on the rationale, opportunities and challenges, along with practical implementation recommendations.  

Presenters:           Linda King, Astellas, eCF Audit Trail Review Team

                                Miko Pietilä, Signant Health, eCF Audit Trail Review Team

Read more
24252627
2829301234
567891011

Upcoming events Events RSSiCalendar export

  • DETAILED AGENDA: eClinical Forum Virtual Workshop, 12-16 October 2020 (10/12/2020 - 10/16/2020 UTC)
    10/12/2020 - 10/16/2020 UTC
    103

    DETAILED AGENDA: 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

    Read more

This form...