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WHO WE ARE
The eClinical Forum is a global network of peers. It provides a non‐competitive environment for innovation, learning and collaboration in clinical research.
eSRA Maintenance Working Group
eSRA (eSource-Readiness Assessment) is a questionnaire used by sites to self-evaluate their electronic systems that may originate or manage data for clinical research. It has been provided, free of charge, since 2016 and is updated annually, based on updates to the underlying regulatory documents and new interpretations from regulatory authorities. It was developed and continues to be updated, with extensive participation of global biopharma, CROs, technology providers, academia and with regulatory review.
It is important that site systems 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 electronic record systems. The eSRA project has developed a free tool that vendors and sites can use to quickly and easily evaluate their systems once for all sponsors, CROs, and regulators.
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.
The eSRA Maintenance Working Group welcomes all feedback/questions on any of the eSRA materials offered via their web page (www.eclinicalforum.org/esra). Please send feedback to esra@eclinicalforum.org. All feedback/questions will be responded to.
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Requirements for Electronic Data for Regulated Clinical Trials - "eCF Requirements" past public releases 2018 - 2023
The eCF REG team puts out a yearly version of the "eCF Requirements" which many orgainizations use to check compliance of their systems against regulatory authority document statements. The previous versions have been requested in order to easily check the requirements that were in place in a particular year.
eCF APAC Autumn Workshop 2024 Announced
Registration is open! Our APAC Autumn workshop will be kindly hosted by Clario at the Hyatt Regency Tokyo Bayin Urayasu, Japan on November 11-12 2024.
eCF Birds-of-a-Feather Round-Table: Risk-Based Source Data Verification
This topic is coming out of a discussion that started at the eCF Workshop in Massachusetts in October. The group decided they wanted more time to delve more deeply into this discussion and to include eCF members from other regions. The discussion will be around:
eCF “Think GCP” Webinar: ICH E6(R3) for eCF Members
Presenter: Rebecca Stanbrook, GCP Strategic Lead, Process & Risk Surveillance, Novartis, EFPIA Topic Lead ICH E6(R3)
About this topic: The final piece of the GCP renovation puzzle, revision 3 of ICH GCP. Understand the background to the renovation, key changes and the philosophy of the changes in this one hour webinar.