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

Winter & Spring 2017 Birds-of-a-Feather Discussions and Technology Showcase Lineup

Winter & Spring 2017 Birds-of-a-Feather Discussions and Technology Showcase Lineup

eCF BoF Discussions and Technology Showcases are a way for members to engage with each other around the globe in conversation about specific issues and technologies. Any member can suggest a topic, suggest a presenter, or offer to present. No topic is too small or too broad to discuss. eCF BoFs and Technology Showcases are offered gratis to eCF members. Please send suggestions to info@eclinicalforum.org. Click on title to see lineup

 

Webinar: Challenges of deploying wearables and mHealth systems in clinical trials

eCF Technology Showcase: 16-Feb-2017 - Registration Required

Webinar: Challenges of deploying wearables and mHealth systems in clinical trials

The use of wearable sensors in the clinical trial marketplace is growing rapidly. These solutions have the ability to provide valuable patient contextual information in near real time and offer the possibility to improve clinical trial efficiency and understanding of clinical outcomes.

Discussion and demonstration facilitated by Jeremy Wyatt of Actigraph;

Open to eCF Members;

Time: 9am New York, 1400 London, 1500 Paris, 10pm Singapore;

Click on title for more information

 

Webinar: Incorporating Visual Learning into Clinical Research

eCF Technology Showcase: 23-Jan-2017 - Registration Required

Webinar: Incorporating Visual Learning into Clinical Research

The growing complexity in clinical trials and complex data sets are driving the need to find more effective ways to share information.  

Discussion & Demonstration by Sam Anwar – Vice President of Engineering, eClinical Solutions LLC;  

Registration is gratis to eCF Members.

Time: UTC/GMT 1400 (9am NYC, 1500 Paris, 10pm Singapore)  Click on title for more information

 


Example of a completed eSRA V2019

Example of a completed eSRA V2019

This example has been anonymized from an actual site completed eSRA assessment. It provides an idea of what the eSRA team considers an appropriate level of commenting. The eSRA team provides no opinion or guidance on these answers -- this is an example only and not to be considered as endorsement for any system with similar eSRA assessment.

BoF Discussion: Interim Data Cuts (Dec 15 2016)

BoF Discussion: Interim Data Cuts (Dec 15 2016)

Time: UTC 1500; 16:00 CET, 10:00 AM EST, 11:00 PM Singapore. We apologize for the inconvenient timeslot in some regions. 

Facilitator: Michelle Flickinger, Array Biopharma;  

Open To: Staff from eClinical Forum member companies, gratis. 

eCF Birds-of-a-Feather sessions focus on the details of a specific topic and are participative discussions, not presentations.  All participants are encouraged to share information and ask questions. Click for more information...

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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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