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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.


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eCF Releases Key Documents and Tools

Partnering for Success

  • 20 November 2015
  • Author: Webmaster1
  • Number of views: 13395
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eCF Releases Key Documents and Tools

eCF Releases several key "Members Only" documents and tools. 

The eCF is releasing 3 documents to eCF members via the eCF website “Members” area (un/pw required). Please feel free to download them and share with other members of your company.

 

  1. Draft White Paper:  Electronic Data Capture in Clinical Trials using Service Providers -- A method for ensuring the Investigator’s control of and continuous access to the CRF data reported to the sponsor when using an independent third party. This document is the result of countless hours of work by the eCF EDC Hosting Team and has been peer-reviewed by several industry groups and key opinion leaders. It will be presented/discussed with the EMA on 30-Nov-2015.
  2. Checklist for Electronic Data Capture Systems in Clinical Trials using Service Providers -- Tool for assessing the regulatory compliance of an i3P‐hosted EDC system used in clinical trials. This checklist is an outgrowth of work done by the eCF to identify key criteria for systems that provide source data for clinical trials (EHRCR Functional Profile (HL7, ANSI, EuroRec), and “eSRA” eSource Readiness Assessment Tool for clinical research sites. Please note: the eSRA is open to the public and can be accessed via www. Eclinicalnetwork.org).
  3. eCF Regulatory Resources Table – This table maps eClinical areas of interest (eg EDC, ePRO, eSubmission, etc) to appropriate regulatory documents from FDA, EMA, PDMA, ICH, other.  The table provides a link to obtaining the document via the internet. This is a working document and will be updated as the eCF REG becomes aware of new documents.
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«October 2020»
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10/7/2020 UTC
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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

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10/12/2020 - 10/16/2020 UTC
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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

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10/12/2020 - 10/16/2020 UTC
103

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

Read more
14
10/12/2020 - 10/16/2020 UTC
103

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

Read more
15
10/12/2020 - 10/16/2020 UTC
103

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

Read more
16
10/12/2020 - 10/16/2020 UTC
103

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

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BoF Round-table: Master Protocol Trial Designs & Data Management Considerations

Facilitator:   Sara Hale, Amgen

Since the release of the FDA guidance for Adaptive Clinical Trial Design, many Sponsors have been working to enable Master Protocol trials. The MP designs includes 1. Basket Trial Design 2 Umbrella Trial Designs and Platform Trial Designs, which more complex in nature in that they are inclusive of multiple sub-studies within a single trial that within a traditional designs would have been separating out into separate trials. Making it necessary to consider fit-for-purpose strategic operational, process and system solutions.

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