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Investigator Site eSourceReadiness Assessment A tool for common assessment across sites and sponsorsVersion:2022.2Date:25 May 2022Status:Public ReleaseAuthor:eClinical Forum eSRA Team The eClinical
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What is investigator site esource-readiness assessment?
An investigator site esource-readiness assessment is an evaluation process that determines whether a clinical trial site has the necessary electronic systems and processes in place to handle electronic source data efficiently and in compliance with regulatory standards.
Who is required to file investigator site esource-readiness assessment?
Typically, the clinical trial sponsors or investigators are required to file the investigator site esource-readiness assessment to ensure that their study sites are prepared to manage electronic data.
How to fill out investigator site esource-readiness assessment?
To fill out an investigator site esource-readiness assessment, the involved parties should provide detailed information about their electronic data capture systems, data management protocols, and staff training on the systems being used.
What is the purpose of investigator site esource-readiness assessment?
The purpose of the investigator site esource-readiness assessment is to verify that clinical trial sites can efficiently collect, manage, and store electronic source data, which ultimately ensures data quality and compliance with regulatory requirements.
What information must be reported on investigator site esource-readiness assessment?
The assessment must report information regarding the site's electronic data systems, processes for data handling, staff qualifications and training, and any challenges or limitations the site may encounter in using e-source.
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