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This is the japanese translation of esra handbook and assessment questionnaire It has been provided, free of charge, since 2016 and is updated annually, based on updates to the underlying regulatory documents and new interpretations from regulatory authorities The translation is provided as a reference to assist sites and sponsors/cros to use the esra
Esra (esource readiness assessment) handbook and assessment questionnaire 持ち、責任を負う必要があります。リスクアセスメント結果は臨床試験責任医師が必須記録としてInvestigator Site Fileにお いて維持管理する必要があります。eSRA は、近年広く利用が進んでいる 2 つのテンプレート (eSource システム用の eSRA Form/S とSite File システ English version 2024 this is the one file that you need to perform an esra assessment
This 2024 version has updates based on the ema guideline on computerised systems and electronic data in clinical trials
Esra materials are updated annually and released at the end of q1 To be notified of future releases and/or to provide feedback to the team, please send an email to esra@eclinicalforum.org Your email address will not be used for purposes other than to inform you of updates to ecf site system assessments. This is the japanese translation of esra handbook and assessment questionnaire.
An eclinical forum team, comprised of cras and data managers from different clinical research sponsor.
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