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    Tokyo 2-3 December 2019
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    Brussels 15-17 May 2019
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    Paris, France 23-25 October 2018
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    Philadelphia, USA 2-4 October 2018
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    Princeton 1-3 May 2018
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    Darmstadt, 15-17 May 2018

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

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Regulatory Expert Group

The team provides expert evaluation of regulatory guidances from Europe, North America and Asia Pacific so that the impact on Clinical Research and eCF operations such as system criteria can be assessed. Consolidation of review comments via this group ensures that the eCF can respond efficiently to regulatory agency timetables for return of comments.

Applied Clinical Trials publishes article on eCF Requirements
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Applied Clinical Trials publishes article on eCF Requirements

Applied Clinical Trials has published an article highlighting the eClinical Forum “Requirements for Electronic Data for Regulated Clinical Trials” (or simply, “eCF Requirements”: http://www.appliedclinicaltrialsonline.com/keeping-regulatory-expectations .  July 8, 2019

The eCF Requirements are based upon statements in regulatory documents (from the FDA, EMA, PMDA and ICH) 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

Release: Requirements for Electronic Data for Regulated Clinical Trials "eCF Requirements" V2019 Members Only
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Release: Requirements for Electronic Data for Regulated Clinical Trials "eCF Requirements" V2019 Members Only

eCF Members Release 25-March-2019

The eClinical Forum is happy to announce the V2019 Members-Only release of the “eCF Requirements”. 

The eCF Requirements 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 data which will become part of a regulated clinical trial are consistent with regulatory requirements. The V2019 Members Release has 21 documents mapped.

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ECF REPRESENTATIVES MEET WITH EMA GCP IWG
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ECF REPRESENTATIVES MEET WITH EMA GCP IWG

Meeting With Interested Parties On Topics Related To E-Source Data/ EDC Tools In Clinical Trials

Representatives from the eClinical Forum participated in the meeting with inspectors and observers in London 12th June to discuss challenges and trends in Clinical Research. We presented the work of the eClinical Forum in the areas of contractual requirements and risk-based software validation…  Expand article to read more...

FDA and OHRP Issue Final Guidance on the Use of Electronic Informed Consent 12/15/2016
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FDA and OHRP Issue Final Guidance on the Use of Electronic Informed Consent 12/15/2016

Re-Posted from eCF LinkedIn Group

The FDA and OHRP published final guidance aimed at providing answers to commonly asked questions about using electronic systems and processes that may employ multiple electronic media to obtain informed consent. Expand the article to read more

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