Clinical Forum Teams work extensively with industry, healthcare organisations, academia regulators to link stakeholders and to facilitate the development of the environment for electronic clinical research. We have conducted surveys, developed tools, built an extensive base of knowledge of information relevant to the successful implementation of eClinical solutions.

Join the eClinical Forum to participate in cross-industry initiatives and to benefit from early access to pre-competitive information on best practices and trends.

Interested in participating in eClinical Forum projects? 


Trial of the Future

Understanding Future Needs and Attributes of Clinical Trials

The team was established in 2019 in order to:

- Understand Future Scenarios for Clinical Trials

- Create a collaborative, structured environment that links technologies and solutions to clinical research challenges

- Identify likely priorities based upon importance, impact and achievability

- Build communication and engagement to advance the case for change


eConsent Working Group

New Working group formulated in April 2019, joint with EUCROF, with members from Pharma, CRO, Investigator and Software Vendor.

There is high interest in the industry on the current data available on the use and future of e-consent, including innovative e-solutions currently available in the industry. The scope is to provide a guide to industry on key consideration and best practices/recommendations for the implementation of e-consent. A draft is anticipated to be released to eCF member for review by Q1 2020, with the key to review EMEA guidance on e-systems prior to finalization of paper for alignment.


eCOA Data Changes

Team of professionals from US, Europe and China who are interested in discussing all aspects of eCOA Data Changes with the intention of writing a white paper that will be released to industry. This team began in June 2019 and anticipate release of a white paper in 1Q 2020.

o Introduction
o Regulatory Background
o eCOA Primer 
o Data Change Scenarios  • Data Can be Changed • Data Cannot be Changed
o Models for Control 
o The Role of RBM 
o Conclusion
o References

Archiving and Decommissioning

In May of 2018 the EMA invited 12 representatives from industry to discuss technical issues concerning the use of computerised systems for clinical research, including representatives of EUCROF and the eClinical Forum.

EUCROF and the eClinical Forum decided to collaborate on a position paper describing industry best practices and recommendations on several topics. An invitation to participate was then extended to all other representatives from industry who had participated in the meeting with the EMA and the majority of them have decided to collaborate on the position paper either as co-authors or as reviewers. One of the primary focuses is Archiving and Decommissioning.This group met again with the EMA in June 2019.

The EMA plans to release an eSystems Guideline (to replace the EMA Source Reflection Paper)  by the end of 2019 


Audit Trail Review

With increased focus on data integrity from regulators, the routine use of audit trail review as a tool is required.   This team will explore and provide guidance on what is the recommended scope for review, provide definitions, determine ‘what’ data (and in what part of the data lifecycle) should be reviewed with an audit trail vs other data integrity controls and finally recommend ‘how’ an audit trail review should be conducted (frequency, visualizations, exception reports etc). A white paper will be released to eCF members by end of 1Q 2020 with the anticipation of releasing it to the public by 3Q 2020.


Regulatory Expert Group (REG)

This group provides expert evaluation of regulatory guidances from Europe, North America and Asia Pacific so that the impact on Clinical Research and eCF operations such as system criteria can be assessed. Consolidation of review comments via this group ensures that the eCF can respond efficiently to regulatory agency timetables for return of comments. A major deliverable from the REG is the "eCF Requirements" which is a set of statements, all based on regulatory documents from FDA, EMA, PMDA, MHRA and ICH that make up the minimal requiements a system that is originating or managing data for clinical research must adhere to. The eCF Requirements are released once/year to the eClinical Forum member companies. Previous years eCF Requirements may be released into the public realm. eCF Member companies are using the eCF Requirements to assist in system evaluations, RFIs and other regulatory and audit actvities. Each eCF Member company may have one representative on the REG team. Member companies believe that the time saved by using the eCF Requirements (rather than evaluating all the regulatory documents from different authorities on their own without this guide) justifies the cost of the eClinical Forum membership.

See "Downloads" section of this website for the public release of the "eCF Requirments" document. eCF members can contact webmaster3@eclinicalforum.org for a current version of this document.


eSRA: A Project to Self-Evaluate the GCP Compliance of Systems Holding Source Data

It is important that electronic health record systems (EHRS) that will supply source data for clinical research be designed and maintained to meet regulatory requirements. Sponsors ultimately bear the responsibility for ensuring that data harvested from these systems are acceptable, and investigators are frequently being asked to complete sponsor-specific assessments of their EHR systems.  The eSRA project has developed a free tool that vendors and sites can use to help to quickly, easily evaluate their systems once for all sponsors, CROs, and regulators.

The eSRA (eSource-Readiness Assessment) tool was developed with extensive participation of global biopharma, CROs, technology providers, academia and with regulatory review.

The tool offers a series of questions based on FDA, EMA and PMDA regulations and guidances. A site can quickly identify if its system and/or processes are compliant with research regulations or if additional processes need to be put into place.

Using this assessment tool will enable sites to quickly provide the information needed by sponsors on GCP compliance of systems holding source data and will enable sponsors to evaluate and manage risk. Regulators and sponsors should feel confident in the quality of eSource coming from assessed sites. The eCF is currently in the process of designing an update to the tool that will include a more sophisticated interface and an interactive online questionaire. The eSRA tool can be accessed via the eSRA tab on this eClinical Forum website. eSRA is updated annually, during the first quarter.