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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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Public Release: English Translation of V2.00 of Japan EDC Management Sheet Public Release: English Translation of V2.00 of Japan EDC Management Sheet
The Regulatory Expert Group is happy to announce the release of the English translation of the JPMA EDC Management Sheet v2.00.  EDC Management Sheet is a tool by which Japan Pharmaceuticals and Medical Devices Agency (PMDA)...

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Members Release: Best Practice Document on Investigator’s Signature Members Release: Best Practice Document on Investigator’s Signature
The eClinical Forum is happy to announce the release of the "Investigator’s signature on electronic Case Report Forms (eCRFs), MR2022”. About the Best Practice Document: There is increased scrutiny by regulatory agencies on the...

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Member Release: "Requirements for Electronic Data for Regulated Clinical Trials" MR2022 Member Release: "Requirements for Electronic Data for Regulated Clinical Trials" MR2022
ABOUT THE ECF REQUIREMENTSThe eClinical Forum has updated their set of Requirements, which are based upon statements in regulatory documents that pertain to the design, development, implementation, and management of electronic systems that support...

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