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.
Notice to those intending to include eCF Site System Assessment Forms in their own materials/applications: the forms are copyrighted by the eClinical Forum in 2024. The eClinical Forum keeps all rights of this material. Please see the License for Fair Use in the Handbooks and “Implementing eSRA” Guide. We welcome our assessment forms to be used in other formats, however, it is required that all question text be used exactly, that all questions are included, that your use is updated when the eCF forms are updated (annually, Q1), and that eClinical Forum is notified in writing and credited. By using these materials, you acknowledge the terms and conditions for use. The eClinical Forum is only responsible for materials as distributed via the eClinical Forum website. If using the eCF form, downloaded from this website in its original format, there is no need to notify eCF.