﻿<?xml version="1.0" encoding="utf-8"?><!--RSS Genrated: Mon, 18 May 2026 05:33:43 GMT--><rss version="2.0" xmlns:atom="http://www.w3.org/2005/Atom" xmlns:dc="http://purl.org/dc/elements/1.1/" xmlns:content="http://purl.org/rss/1.0/modules/content/" xmlns:ev="http://purl.org/rss/1.0/modules/event/"><channel><title>eClinical Forum - Report</title><link>https://eclinicalforum.org:443/downloads/rss/category/454/report</link><atom:link href="https://eclinicalforum.org:443/downloads/rss/category/454/report" rel="self" type="application/rss+xml" /><description>RSS document</description><item><dc:creator><![CDATA[Jana Summa]]></dc:creator><title><![CDATA[Implementing eSRA: Sponsor Guide 2026]]></title><link>https://eclinicalforum.org/downloads/implementing-esra-sponsor-guide-2026</link><description><![CDATA[ eSRA is a common tool across sites and sponsors for assessing the readiness of site systems to be used in the conduct of regulated clinical trials 

 This document is intended to provide ...]]></description><pubDate>Mon, 04 May 2026 12:45:00 GMT</pubDate><guid>https://eclinicalforum.org/downloads/implementing-esra-sponsor-guide-2026</guid><dc:identifier><![CDATA[ab8edbe3-2944-49a2-aab5-6e6fd231b1cb-332]]></dc:identifier></item><item><dc:creator><![CDATA[Jana Summa]]></dc:creator><title><![CDATA[V2026 vs V2025 and Regulatory Basis]]></title><link>https://eclinicalforum.org/downloads/v2026-vs-v2025-and-regulatory-basis</link><description><![CDATA[  Comparison of V2026 to V2025.3 for both Form/S (eSource) and Form/F (eFile) and mapping to regulatory authority document statements  

 eCF eSRA Release 2025 is based on regulatory documents from ...]]></description><pubDate>Mon, 04 May 2026 12:42:00 GMT</pubDate><guid>https://eclinicalforum.org/downloads/v2026-vs-v2025-and-regulatory-basis</guid><dc:identifier><![CDATA[ab8edbe3-2944-49a2-aab5-6e6fd231b1cb-331]]></dc:identifier></item><item><dc:creator><![CDATA[Jana Summa]]></dc:creator><title><![CDATA[eSRA Handbook and Assessment Forms V2026]]></title><link>https://eclinicalforum.org/downloads/esra-handbook-and-assessment-forms-v2026</link><description><![CDATA[  eSRA (e-Site System Readiness Assessment) Handbook and Assessment Forms: ENGLISH Version 2026  

  This is the ONE FILE that you need to perform an Assessment of your e-Source or e-File Systems  ...]]></description><pubDate>Mon, 04 May 2026 12:27:00 GMT</pubDate><guid>https://eclinicalforum.org/downloads/esra-handbook-and-assessment-forms-v2026</guid><dc:identifier><![CDATA[ab8edbe3-2944-49a2-aab5-6e6fd231b1cb-330]]></dc:identifier></item><item><dc:creator><![CDATA[Jana Summa]]></dc:creator><title><![CDATA[Public release of "Strategies for implementing Audit Trail Review" Industry Position Paper]]></title><link>https://eclinicalforum.org/downloads/public-release-of-strategies-for-implementing-audit-trail-review-industry-position-paper</link><description><![CDATA[  The eClinical Forum is releasing the public version of its industry position paper "Audit Trail Review: Strategies for implementing Audit Trail Review".   

 Since the publication of the 2021 ...]]></description><pubDate>Thu, 12 Feb 2026 10:09:00 GMT</pubDate><guid>https://eclinicalforum.org/downloads/public-release-of-strategies-for-implementing-audit-trail-review-industry-position-paper</guid><dc:identifier><![CDATA[ab8edbe3-2944-49a2-aab5-6e6fd231b1cb-320]]></dc:identifier></item><item><dc:creator><![CDATA[Suzanne Bishop (eCF Facilitator)]]></dc:creator><title><![CDATA[Public release of the "Requirements for Electronic Data for Regulated Clinical Trials" (commonly referred to as the “eCF Requirements”)]]></title><link>https://eclinicalforum.org/downloads/public-release-of-the-requirements-for-electronic-data-for-regulated-clinical-trials-commonly-referred-to-as-the-ecf-requirements-1</link><description><![CDATA[   What expectations do FDA, EMA, PMDA, MNPA, MHRA and ICH put on your e-clinical systems … and how can you easily keep an eye on them as they change?     Happily for you – the eClinical Forum is ...]]></description><pubDate>Sun, 27 Apr 2025 14:45:00 GMT</pubDate><guid>https://eclinicalforum.org/downloads/public-release-of-the-requirements-for-electronic-data-for-regulated-clinical-trials-commonly-referred-to-as-the-ecf-requirements-1</guid><dc:identifier><![CDATA[ab8edbe3-2944-49a2-aab5-6e6fd231b1cb-295]]></dc:identifier></item><item><dc:creator><![CDATA[Suzanne Bishop (eCF Facilitator)]]></dc:creator><title><![CDATA[eSRA Handbook and Assessment Forms V2025.3]]></title><link>https://eclinicalforum.org/downloads/esra-handbook-and-assessment-forms-v20253</link><description><![CDATA[  eSRA (e-Site System Readiness Assessment) Handbook and Assessment Forms: ENGLISH Version 2025.3  

  This is the ONE FILE that you need to perform an Assessment of your e-Source or e-File Systems ...]]></description><pubDate>Fri, 25 Apr 2025 12:20:00 GMT</pubDate><guid>https://eclinicalforum.org/downloads/esra-handbook-and-assessment-forms-v20253</guid><dc:identifier><![CDATA[ab8edbe3-2944-49a2-aab5-6e6fd231b1cb-291]]></dc:identifier></item><item><dc:creator><![CDATA[Suzanne Bishop (eCF Facilitator)]]></dc:creator><title><![CDATA[Implementing eSRA - Sponsor Perspective]]></title><link>https://eclinicalforum.org/downloads/implementing-esra-sponsor-perspective-3</link><description><![CDATA[ eSRA is a common tool across sites and sponsors for assessing the readiness of site systems to be used in the conduct of regulated clinical trials 

 This document is intended to provide ...]]></description><pubDate>Thu, 24 Apr 2025 12:29:00 GMT</pubDate><guid>https://eclinicalforum.org/downloads/implementing-esra-sponsor-perspective-3</guid><dc:identifier><![CDATA[ab8edbe3-2944-49a2-aab5-6e6fd231b1cb-292]]></dc:identifier></item><item><dc:creator><![CDATA[Suzanne Bishop (eCF Facilitator)]]></dc:creator><title><![CDATA[V2025 vs V2024 and Regulatory Basis]]></title><link>https://eclinicalforum.org/downloads/v2025-vs-v2024-and-regulatory-basis</link><description><![CDATA[  Comparison of V2025 to V2024 for both Form/S (eSource) and Form/F (eFile) and mapping to regulatory authority document statements  

 eCF eSRA Release 2025 is based on regulatory documents from ...]]></description><pubDate>Wed, 23 Apr 2025 13:45:00 GMT</pubDate><guid>https://eclinicalforum.org/downloads/v2025-vs-v2024-and-regulatory-basis</guid><dc:identifier><![CDATA[ab8edbe3-2944-49a2-aab5-6e6fd231b1cb-293]]></dc:identifier></item><item><dc:creator><![CDATA[Suzanne Bishop (eCF Facilitator)]]></dc:creator><title><![CDATA[Requirements for Electronic Data for Regulated Clinical Trials - "eCF Requirements" past public releases 2018 - 2023]]></title><link>https://eclinicalforum.org/downloads/requirements-for-electronic-data-for-regulated-clinical-trials-ecf-requirements-past-public-releases-2018-2023</link><description><![CDATA[ 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 ...]]></description><pubDate>Fri, 08 Nov 2024 15:54:00 GMT</pubDate><guid>https://eclinicalforum.org/downloads/requirements-for-electronic-data-for-regulated-clinical-trials-ecf-requirements-past-public-releases-2018-2023</guid><dc:identifier><![CDATA[ab8edbe3-2944-49a2-aab5-6e6fd231b1cb-281]]></dc:identifier></item><item><dc:creator><![CDATA[Suzanne Bishop (eCF Facilitator)]]></dc:creator><title><![CDATA[Public release of the "Requirements for Electronic Data for Regulated Clinical Trials" (commonly referred to as the “eCF Requirements”)]]></title><link>https://eclinicalforum.org/downloads/public-release-of-the-requirements-for-electronic-data-for-regulated-clinical-trials-commonly-referred-to-as-the-ecf-requirements</link><description><![CDATA[   What expectations do FDA, EMA, PMDA, MNPA, MHRA and ICH put on your e-clinical systems … and how can you easily keep an eye on them as they change?     Happily for you – the eClinical Forum is ...]]></description><pubDate>Mon, 15 Jul 2024 14:45:00 GMT</pubDate><guid>https://eclinicalforum.org/downloads/public-release-of-the-requirements-for-electronic-data-for-regulated-clinical-trials-commonly-referred-to-as-the-ecf-requirements</guid><dc:identifier><![CDATA[ab8edbe3-2944-49a2-aab5-6e6fd231b1cb-273]]></dc:identifier></item></channel></rss>