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.

We are pleased to announce that registration is now open for our next European Workshop in Darmstadt Germany on June 14-16 hosted by eClinical Forum.

This hybrid workshop is available for face-to-face or remote participation.

READ MORE to download Agenda

REGISTER NOW

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 joint Working Group on AI/ML by eClinical Forum and EUCROF is monitoring the evolution of AI/ML technologies in the Life Sciences domain and addressing relevant topics that are of major interest for clinical research.

The DCT Working Group is a joint effort between eClinical Forum and EUCROF. The team's objectives are to define DCT terms and to develop position papers and roadmaps on DCT solutions that simplify patient and site experiences. 

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

The eClinical Forum is happy to announce the release of the "Investigator’s signature on electronic Case Report Forms (eCRFs), PR2.1"

About the Best Practice Document: There is increased scrutiny by regulatory agencies on the collection of investigator’s signatures as evidence of the overall oversight on the eCRF is reported to the sponsor.  eClinical Forum PI Signature Working Group was formed in March 2021 to update the best practice document originally issued in 2017 by identifying best practices that are based on compliance to regulatory requirements and on risks such as reputation, credibility, legal liability of the data being used by the sponsor.