• 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:  Patient Engagement: Techniques, Tools and Technologies

Wed, March 27 at UTC 1300 and UTC 1900 (28-March at 6am for Sydney AUS)

Birds-of-a-Feather Webinar:  Patient Engagement: Techniques, Tools and Technologies

FacilitatorDavid Stein, D. Bartley Consulting

Opening StatementsJeff Lee, President, eCOA & Patient Engagement, CRF Bracket and Martin Collyer, “Patient Engagement” Consultant

Duration: one hour (offered at UTC 1300 and UTC 1900)   Note: Sydney AU will be at 6am local time on 28-March.

(click on title for more information)

eSRA (eSource Readiness Assessment) Handbook and Assessment Questionnaire

ENGLISH Version 2020.2

eSRA (eSource Readiness Assessment) Handbook and Assessment Questionnaire

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

- Sites should complete an eSource-Readiness Assessment (eSRA) to self-assess their healthcare computerized systems (e.g. EHR/EMR) for readiness to originate or handle electronic data that could become part of a clinical research study.

- Sponsors/CROs will find useful information in the Handbook in order to evaluate a completed eSRA from a site, to determine if data that originated in the site's healthcare computerized system complies with clinical research regulations

This Version 2020.2 has had minor updates to clarify the text from V2020. The eSRA questionnaire has not been updated in V2020.2, and will be updated as per the annual schedule and released in March 2021.

- Download the Handbook file and save to your computer. The instructions are in section 3 and the assessment is in section 5. Sites should complete the assessment and email it to their sponsors.

Click on title to get to the download screen.

What is the difference between the V2020 and V2019 eSRA?

Changes are minor -- see the list

While several additional regulatory documents were mapped to the eSRA questions, they did not significantly change eSRA between V2019 and V2020. No questions were added or deleted. Some question text were modified to improve clarity. Please download the file showing each question with it's change.

BoF Webinar: EHR to EDC for Automated Population of CRF

June 27 at UTC 1400

BoF Webinar: EHR to EDC for Automated Population of CRF

Where is your organization on the EHR to EDC journey?  Not started, early prototypes, other?

What is the principal value your organization expects from EHR to EDC one day? 

  • Getting patient data sooner than typical industry 8+ day lag time from visit to EDC data entry?
  • Higher quality data leading to less “back and forth”?  
  • Direct cost savings on SDV as data sourced from EHR doesn’t need to be SDV'd?

Come join us as we cover a perspective of some of the work happening across the industry to take advantage of this valuable Data Source.

Regulatory documents used as a basis for the eClinical Forum eSource Readiness Assessment (eSRA)

Release 2020

Regulatory documents used as a basis for the eClinical Forum eSource Readiness Assessment (eSRA)

eCF eSRA Release 2020 is based on regulatory documents from FDA (USA), EMA (European Union), PMDA (Japan), CMPS (China) and ICH (International). The eClinical Forum will continue to monitor new releases and updates of regulatory documents from these agencies to determine if the eSRA template questions should be updated.

Click on document title to download.

RSS
First45679111213Last

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)
«January 2021»
MonTueWedThuFriSatSun
28293031123
45678910
11121314151617
18192021222324
2526
Birds-of-a-Feather Round Table Discussion:  New recommendations from EMA on the frequency of investigators’ signature collection on eCRF data

Birds-of-a-Feather Round Table Discussion: New recommendations from EMA on the frequency of investigators’ signature collection on eCRF data

In July 2020, EMA released a new Q&A to provide further expectations on continuous oversight and frequency of investigators’ signature collection on eCRF data reported to the sponsor. Prior to filing a marketing authorization application, all eCRF data should be signed and dated. But also important data such as that related to reporting of SAEs, adjudication of important events and endpoint data, DSMB review, should be signed off in a timely manner. In addition, a timely review and sign-off of data that are entered directly into the CRF as source is particularly important.

The intent of this webinar is to identify if there are new challenges, and if any – to proceed with an update to the eCF best practices on investigator signatures document that was released in 2017.

Read more
2728293031
1234567

Upcoming events Events RSSiCalendar export