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The eClinical Forum Download area contains publically available surveys, presentations, articles and reports that can inform your decision making, challenge your thinking, and identify new technological and regulatory trends related to eClinical trials.

A much more extensive archive of information is available to members

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Disclaimer:The information presented in these works draws upon the combined understanding and knowledge of the eClinical Forum and is provided as an aid to understanding the environment for electronic clinical research. The opinions of the author(s) and the eClinical Forum do not necessarily reflect the position of individual companies.The content is unconfirmed and users should assess the content and opinions in the light of their own knowledge, needs and experience as well as interpretation of relevant guidance and regulations.

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Regulatory Advisory Group (REG)

The REG team reviews, evaluates and interprets documents from regulatory authorities. The team is comprised of regulatory professionals from all aspects of eClinical Forum (pharma, technology vendors, support vendors, sites). For draft documents, comments are submitted to regulatory authorities. Final documents are mapped to the "eCF Requirements" which takes all of the requirements and guidance directions that pertain to electronic data and electronic systems that support clinical research, from these regulatory authorities, and boils them down into 37 unique statements. This is updated annually and released to eCF members. Previous year's "eCF Reqs" are released to the public.The eCF Requirements can be used to determine if systems that handle data which will become part of a regulated clinical trial are consistent with regulatory requirements and if systems and process that manage these data have the necessary features. Each eCF member company may have one representative on the REG team.

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