"This is the best use of my time to remain current with what is going on in the industry."
WHO WE ARE
The eClinical Forum is a global network of peers. It provides a non‐competitive environment for innovation, learning and collaboration in clinical research.
eClinical Forum has released the 2024 version of their “eSource Readiness Assessment” – eSRA. It is a response to the growing expectation by regulatory agencies for clinical trial sponsors to verify that clinical research site systems (e.g., EHRs) comply with requirements to protect confidentiality and provide accurate and reliable data for the use in a regulated research environment. In particular, the EMA Guideline on computerised systems and electronic data in clinical trials (effective Sep 2024) states s in A6.2: “the sponsor should assess the systems in use by the investigator/institution to determine whether the systems are fit for their intended use in the clinical trial (e.g. include an audit trail). The assessment should cover all computerised systems used in the clinical trial and should include consideration of the rights, safety, dignity and wellbeing of trial participants and the quality and integrity of the trial data. If the systems do not fulfil the requirements, the sponsor should consider whether to select the investigator/institution. The use of systems not fulfilling requirements should be justified, either based on planned implementation of effective mitigating actions or a documented impact assessment of residual risks.”
eSRA is a free tool and easy to access via one .pdf file that includes a Handbook and Assessment questionnaire. It can be downloaded from eSRA (eclinicalforum.org) It truly is free – we are not gathering your email or other identifying information in return.
From the EMA Guidance mentioned above, and FDA’s guidance “Use of Electronic Health Record Data in Clinical Investigations” (July 2018), and the EMA reflection paper on eSource (June 2010), there is a clear expectation that sponsors evaluate the healthcare systems that may provide data for their studies. However, identifying all global requirements for these site systems can be a daunting task for sponsors, investigative sites and technology vendors. To add to the complexity, sponsor companies have varied ways of assessing and documenting an site system’s readiness for use in clinical research, making it time consuming for sites to comply.
The eClinical Forum, a non-commercial, non-profit global organization with over 45 organizations active in clinical research, has established criteria to allow compliant use of data from healthcare systems for regulated clinical research. Their eSource Readiness Assessment (eSRA) questionnaire has been created with sponsors and research sites to simplify the self-assessment of research site systems. It is a standardized approach and free of charge. It allows sites to reuse their assessment across all their clinical trial sponsors. It provides all users (clinical research sponsors, CROs, sites, regulators, technology vendors) with the ease of a common assessment that is solely based on regulatory guidance. eSRA has already been used in several thousand sites worldwide since 2016. The 2024 version has been updated based on regulatory guidance issued during 2023.
Many valuable resources are available for free download on eSRA (eclinicalforum.org).
As always, we appreciate your feedback and questions regarding eSRA. We are particularly interested if sponsors or CROs evaluate eSRA and decide instead to make their own site system assessment as we feel strongly that sites are best served by being able to complete one system assessment (eSRA) to provide to all of their sponsors. Please send comments and questions to esra@eclinicalforum.org .
NOT A MEMBER?
eCF Birds-of-a-Feather Webinar: Site experience in the day-and-age of hybrid e-trials
Back by popular demand! Dr. van de Walle presented at the hybrid European eCF workshop in May … and we just ran out of time to answer all the questions! So many requests to ask Viviënne to present again with more time. So, here it is! Not to be missed! Viviënne is a full-time investigator and founder of an indepenent research site. She has vast site and patient experience and will share her insight into how hybrid trials are going for the sites and the patients.
eCF Views & News
We send out a brief monthly newsletter via email to all our active eCF members to keep them abreast of the activities of eCF that they can participate in. The more who participate, the better we are "A Network Powered by Peers". Click to see the most current newsletter.
2024 Members Release of the "Requirements for Electronic Data for Regulated Clinical Trials" (commonly referred to as the “eCF Requirements”)
The "eCF Requirements" Members Release V2024 has been released. This is a significant accomplishment by the eClinical Forum’s “Regulatory Expert Group” (REG) as they have put in countless hours over many years to be able to produce such a comprehensive list of compliance requirements for electronic systems that will manage data used in regulated clinical research, against regulations and guidances from 40 different documents from FDA, EMA, PMDA, NMPA, MHRA and ICH and ISO.
Public release of the "Requirements for Electronic Data for Regulated Clinical Trials" (commonly referred to as the “eCF Requirements”)
The eClinical Forum is releasing its 7th public version of 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 FDA, EMA, PMDA, MNPA, MHRA and ICH , and boils them down into 37 unique statements or "eCF Requirements".
eCF Birds-of-a-Feather Webinar: Protocol Optimization using AI/ML
We will be discussing the transformative potential of Artificial Intelligence (AI) and Generative AI in clinical development.
eCF Technology Showcase Webinar: OpenClinca “Unlocking Clinical Data from EHRs”
What if site users could launch the eCRF with a single click from the patient’s chart, and automatically populate CRFs with data from the chart? This is a Technology Showcase hosted by our newest eCF member, OpenClinica.
eCF Free Public Webinar: Regulatory Requirements for Electronic Data/Systems for Clinical Trials, and associated site system assessments
The eClinical Forum is pleased to offer a free public webinar – to provide information on our 3 free tools: The “eCF Requirements” (Requirements for electronic data for regulated clinical trials), eSRA (Site eSource-Readiness Assessment), and ISF (Investigator Site File System) Assessment. 18-Sept-24: Registration Required.
eCF Americas Autumn Workshop 2024 Announced
Registration is open! Our Americas Autumn workshop will be kindly hosted by eClinical Solutions at their offices in Mansfield, Massachussetts (near Boston/Patriots Stadium) on October 22-24 2024.