This is the ONE FILE that you need to perform an eSRA Assessment.

How to assess site's systems for appropriateness of collecting data for regulated clinical research. (Version 2023)

What has changed?

The eClinical Forum is happy to announce the Public release of the "eCF Requirements for Electronic Data for Regulated Clinical Trials PR2022"

ABOUT THE ECF REQUIREMENTS:  The eClinical Forum has produced a set of Requirements, which are based upon statements in regulatory documents that pertain to the design, development, implementation, and management of electronic systems that support clinical research data as well as those statements that pertain to the handling of data that will be used in a regulated clinical trial.  We have reviewed regulatory documents from the FDA, EMA, PMDA, NMPA, MHRA and ICH to produce this set of requirements. Each Requirement has as its basis one or more statements from one or more of these regulatory documents. The Requirements can be used to determine if systems, that source or manage data which will become part of a regulated clinical trial, are consistent with regulatory requirements and if systems and process that manage these data have the necessary features.

The current technology landscape is becoming more unsustainable for research sites, who are inundated with cubbies of paper binders and a growing number of systems to manage. At the same time, sponsors want to work more efficiently with sites without adding to their already heavy workload.  In this one-hour webinar, eClinical Forum member, Veeva, will show how sites and sponsors are saving time, reducing redundant work, and working together by using Veeva’s connected technology for improving the site-sponsor relationship.

The digitalization of clinical trials and operations has been at the forefront of pharmaceutical and med-tech modernization strategies over the last two decades. However, many companies are still struggling to digitize their clinical operations for various reasons: old habits, fear of adopting and rolling out an electronic solution, potential delays on deadlines, or concerns about quality and compliance. eCF Member BSI will share their thoughts on why a unified CTMS and eTMF is crucial in running clinical trials in the age of digitization and technology, while providing examples with their CTMS and eTMF.  

We are pleased to announce our next Americas Workshop in Blue Bell, PA USA on May 15-17 kindly hosted by Signant Health.

This workshop will be available for face-to-face and remote participation.

We hope you can join us!

The clinical trial industry is undergoing a rapid transition toward decentralization, where some or all health assessments are performed remotely in participants’ homes instead of in medical centers. Adopting artificial intelligence in this setting can empower more patients to enroll in trials, successfully complete them without burden, and submit high-fidelity assessments of their health. In this talk, the presenters will discuss insights from their recent article in Nature Medicine on this topic.  The article can be viewed at: Artificial intelligence can improve patients’ experience in decentralized clinical trials | Nature Medicine

The intention of this webinar is to introduce you to the newest eCF Site Assessment -- the draft eInvestigator Site File Questionnaire (eISFQ). Each question in the eISFQ is based on regulatory authority document statements. It is intended for sites to self-assess their eISF such that sponsors can determine if it is suitable to use for their regulated clinical trials. The eCF eISFQ Team intends to start a pilot with the the eISFQ in late 1Q '23. We would like to present this information to our members to get your feedback and to inspire interest in participating in the pilot.

Developing a questionnaire to assist sites in evaluating their e-Investigator Site File systems against clinical research regulatory regulations and recommendations.

“Birds-of-a-Feather” Webinars are provided monthly, to get those with similar interests together.  Anyone from an eCF member company (around the globe!) can participate, gratis. All eCF members can suggest a topic and/or lead a discussion.