CORE Reference

9:00 AM - 10:30 AM

CORE Reference provides an authoritative open-access resource to support the authoring of disclosure-ready clinical study reports (CSRs) for interventional studies and was registered as a reporting guideline with EQUATOR network in 2016. Reflecting the ongoing value to EMWA members, CORE Reference was designated an EMWA Special Project in 2022 with the aim of providing Continuous Professional Development (CPD) for the regulatory medical writing community through surveillance of regulatory reporting and public disclosure landscapes (see https://www.emwa.org/resources/core-reference/).

In this free conference session, the CORE Reference team will provide attendees with important up-to-date information on regulatory reporting and public disclosure landscapes including a review of the revised transparency rules for Clinical Trials Regulation/Clinical Trial Information System (CTR/CTIS) and Policy 0070. Late-breaking regulatory topics will also be covered including (if available) the ICH M11 final protocol template. The team will provide an update on the CORE Reference 2023 Utility Survey carried out in December 2023.
 
Please note that due to the rapidly changing nature of the regulatory landscape the content of the session may change to reflect important late-breaking regulatory reporting updates.