eClinical Forum now has 2 FREE assessment forms for sites to self-assess their systems for use in regulated clinical trials. We are excited to release the first version of the “ISF System Assessment”. This assessment form is very similar to our eSource-Readiness Assessment (eSRA) and is, like eSRA, based on regulatory documents from regulators around the globe.
It is a response to the growing expectation by regulatory agencies for clinical trial sponsors to verify that clinical research site systems 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.”
The eClinical Forum offers 2 system assessment forms for investigator sites, sponsors, CROs, and regulators to use free of charge, to evaluate the suitability of an investigator site system to provide data/records for clinical trials. They are:
- e-Source-Readiness Assessment (eSRA)
- e-Investigator Site File System Assessment (ISF Assessment)
The 2 system assessment forms contain questions based on regulations and guidelines from global regulatory agencies for clinical research. Since 2016, eSRA has been globally in use and regulators have accepted its inclusion in study materials. In 2024, the The ISF Assessment, based on eSRA, was released on the request of our eSRA users. The eCF intends to publish an update to these materials annually, in Q1, to keep current with regulations and guidelines.
- Each assessment form is packaged in a handbook providing guidance to sites on how to complete the form. The form should not be separated from the handbook, except after completion.
- The document “Implementing eSRA – Sponsor Assessment”, while written for eSRA, applies equally to implementing the ISF Assessment.
- A joint document, “Regulatory documents used as a basis for the eClinical Forum eSRA and ISF Assessments” shows the correlation between these 2 assessment tools and the underlying regulatory documents.
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. Both assessment forms have 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, and allows sites to reuse their assessment across all their clinical trial sponsors. These assessment forms will be updated annually, based on new information that has been provided by regulators during the year.
Both assessments and all associated resources can be accessed (for free) from the tab on this website labeled "Site Sys Assmts" ... or by using these links:
https://www.eclinicalforum.org/site-sys-assmts … or by using this link: Site Sys Assmts (eclinicalforum.org)
The original tab, used to access eSRA (eSource-Readiness Assessment) since 2016, will remain available until 1-July-2024 and then it will be removed and eSRA will only be available through the joint webpage with the ISF Assessment. Please update any internal materials you have that point to the eSRA webpage, to now point to https://www.eclinicalforum.org/site-sys-assmts
As always, we appreciate your feedback and questions regarding our assessment forms. Please send comments and questions to esra@eclinicalforum.org .