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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

Success! eClinical Forum 2020 Spring Meetings replaced with Virtual Global Workshop 11-13 May 2020

  • 5/11/2020 - 5/14/2020
  • Author: Webmaster1
  • Number of views: 4270
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Success! eClinical Forum 2020 Spring Meetings replaced with Virtual Global Workshop 11-13 May 2020

The Virtual Workshop on May 11-13 that replaced the planned face-to-face Spring Workshops in Helsinki, Finland and Princeton, NJ was a huge success.  It was attended by over 130 members from around the globe, representing 46 member companies -- many of whom would not have been able to attend a face-to-face meeting and this was their first eCF workshop. 4 EMA inspectors and several guests also attended. Evaluations gave the workshop a 4.3/5.0 which is lower than our face-to-face workshops, but for our first virtual workshop we are happy with this grade!  A few comments from the evaluations: "Always an excellent group with many real experts.  The interactions are very good."  "Congratulations on an excellent event.  Everything worked well.  Sure, we missed the networking and evening events, but this worked well."  "eClinical Forum is a fantastic source of information about the landscape of eClinical today."  "eCF continues to be incredible value for money"

We are planning for another Virtual Workshop in Autumn 2020 (the week of October 12-16) and hoping to return to face-to-face workshops for Spring 2021. We now have a lot of good ideas for improvements for our 2nd Virtual Workshop! If anyone wants to make suggestions, please send to info@eclinicalforum.org. Thanks!!

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

Date: Tuesday, April 21 2020 Duration: One hour

  • 4/21/2020
  • Author: Webmaster1
  • Number of views: 2412
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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?

eCF Requirements for Electronic Data for Regulated Clinical Trials V2019PR

  • 12 March 2020
  • Author: Webmaster1
  • Number of views: 135
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eCF Requirements for Electronic Data for Regulated Clinical Trials  V2019PR

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

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

March 24 2020

  • 3/24/2020
  • Author: Webmaster1
  • Number of views: 1257
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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.

2020 is our 20th Anniversary Year!

  • 12 December 2019
  • Author: Webmaster1
  • Number of views: 2120
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2020 is our 20th Anniversary Year!

A lot has happened in electronic support for clinical research in the last 20 years ... and eClinical Forum has been there discussing it all!  We are pleased to be celebrating our 20th anniversary year, stronger than ever with 45+ member companies (and growing), meetings on 3 continents, global webinars that have been attended by members in over 25 countries, very active project teams, meetings with regulators, and freely adding to the knowledge base of the industry. Any organization working in this space is welcome to join. Please see the membership tab on our website (www.eclinicalforum.org) or contact us for more information!  info@eclinicalforum.org

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

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

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Position Paper: Trial Master File Archiving and the Decommissioning of Computerised Systems Used in Clinical Trials, PR1

Position Paper: Trial Master File Archiving and the Decommissioning of Computerised Systems Used in Clinical Trials, PR1

The eClinical Forum is happy to announce the public release of a position paper titled “Decentralized TMF Archives and The Decommissioning Of Computerised Systems Used In Clinical Trials”.  This position paper was written by a joint task force from EUCROF and the eClinical Forum, with representatives from other industry associations including ECRIN, the ePRO consortium, Medicines for Europe and the RQA.

ABOUT THE POSITION PAPER: Following the completion of a clinical trial, the essential documents that make up the TMF (Trial Master File) are retained and archived by the sponsor, the investigator and, in some cases, sub-contractors to the sponsor and/or investigator. The position paper highlights 11 key positions: seven positions concerning the archiving of the TMF and four positions concerning the archiving of the electronic data. These positions address areas where regulatory expectations are not always seen as being aligned with industry practices.

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Birds-of-a-Feather Webinar: Practical Considerations when implementing eConsent

Birds-of-a-Feather Webinar: Practical Considerations when implementing eConsent

This webinar introduces the NEW "Practical Guide to eConsent" which addresses key themes and hots topics and provides a view on the modernization of the clinical trials informed consenting process, including the current perception shift of eConsent adoption in light of the COVID-19 pandemic.  This is a joint work by the eClinical Forum and EUCROF.

 

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

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.

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