LEVERAGING KNOWLEDGE - DRIVING PERFORMANCE - DESIGNING THE FUTURE

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.


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ECF Teams and Projects

Best Practice Document on Investigator’s Signature 01 October 20220

Best Practice Document on Investigator’s Signature

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. 

Members Release: Best Practice Document on Investigator’s Signature 07 April 20220

Members Release: Best Practice Document on Investigator’s Signature

The eClinical Forum is happy to announce the release of the "Investigator’s signature on electronic Case Report Forms (eCRFs), MR2022”.

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. 

PI Signatures - ENDED 02 November 20160

PI Signatures - ENDED

Evaluating regulations and guidances pertaining to principal investigator signatures on study data and materials

EDC Hosting - ENDED 26 November 20130

EDC Hosting - ENDED

Best practices for data transcribed to electronic data collection tools

Risk-Based monitoring - ENDED 15 May 20120

Risk-Based monitoring - ENDED

Best practices for ensuring clinical data quality

EHR4CR - ENDED 15 March 20110

EHR4CR - ENDED

Re-use of Electronic Health Records for Clinical Research