The EMA, FDA and MHRA have all issued guidance recommending that sponsors ensure that the site’s systems and processes are appropriate to protect the integrity, security and confidentiality of data to be used in a clinical trial. Since 2016, the eClinical Forum has offered their “eSource-Readiness Assessment” (eSRA) to provide a standardized approach, aligned with regulatory expectations, for sites to assess and document the readiness of their electronic data systems for sourcing data for clinical research. This standardized assessment is appropriate for reuse across their clinical trial sponsors. It is free for any site, sponsor, or CRO to use anywhere in the world. All eSRA questions are based on regulatory document statements.
The eCF eSRA team is constantly monitoring communications from regulatory agencies, as well as feedback from eSRA users, in order to keep the eSRA questionnaire up-to-date. Thank you for taking this brief survey in order to gain valuable information for improving eSRA.