Introduzione
This virtual course in 2 sessions covers scheduling, managing and authoring of clinical study reports (CSRs) for modern design clinical studies. It discusses the stages of preparation of CSRs in the context of precursor documents including the clinical study protocol (CSP), the statistical analysis plan (SAP), and the incorporation of study data. Components of the integrated CSR include narratives and appendices, and the preparation of these sections of the CSR will also be covered. Scheduling an achievable reporting timeline for this complex and multi-component document will be explained.
The practical use of CORE Reference for writing integrated CSRs is demonstrated. Open access CORE Reference (www.core-reference.org/) launched in 2016, provides interpretational guidance on CSR authoring that incorporates ICH, regional (EU and US) guidances and real-world insights. CORE Reference helps writers to author CSRs that share clinical trial data responsibly, and in accordance with current public disclosure requirements.
At the end of this course participants should understand the resources and have gained the knowledge to schedule, manage, write and deliver draft through final version CSRs that are of the highest quality, and are fully ICH compliant. By completing the course, participants will also gain insight into the public disclosure requirements that a CSR must fulfil.
MODULE 1
General Introduction
- Meeting agenda
- Getting to know each other
Part 1: Process Overview, Components and Stages of Preparation of the Integrated CSR
- Background and Overview of CSR Writing
- Shell CSR
- Draft CSR
- Final CSR
Part 2
- CSR Appendices
- CSR Narratives
- Overnight quiz
MODULE 2
Part 1: CSR Authoring Using a ‘State of the Art’ Tool
- Quiz answers
- Introduction to CORE Reference
- CORE Reference web tour www.core-reference.org
- Common areas of confusion in ICH E3 – group discussions
Part 2: CORE Reference: ‘CLARITY’ in clinical study reporting
- How CORE Reference solves inconsistencies in areas of ICH E3 confusion; selected examples
- CORE References appendices and annexes
- Added value – results posting efficiencies
Part 3: CORE Reference ‘OPENNESS’ in clinical study reporting
- Transparency and disclosure environment
- Public disclosure requirements
- CORE Reference approach
- EMA, Health Canada – publicly disclosed CSRs
- Changing concepts and culture
Part 4: Close
- Closing remarks; are expectations met and any remaining questions not covered through the modules
- Feedback forms reminder
Regulatory medical writers working in the contract research organisation or pharmaceutical company environment who write or review clinical study reports (CSRs).
Medical writing managers who oversee regulatory medical writers and who wish to ensure that they are incorporating industry standards into their regulatory writing process would also benefit from attending. Participants will be expected to complete a ‘needs analysis ’ form prior to the course to provide the course leader with insights to allow for an optimal teaching and learning experience.
Participant experience
Participants must have written at least one CSR or reviewed several and have working knowledge of International Council for Harmonisation (ICH) reporting guidelines.
This online course will be highly interactive with discussion and questions encouraged throughout the two virtual sessions. In each session there will be an opportunity for participants to actively participate. Participants are asked to bring a hat or cap to the sessions to facilitate their on-screen participation.
Docente/i
Sam Hamilton
Sam Hamilton is a postdoctoral virologist with 30 years in clinical and regulatory medical writing roles, including leadership positions, in the pharmaceutical industry. Sam is an expert in writing and managing clinical-regulatory documentation for medicines licensing, and am international speaker in the area of public disclosure of clinical-regulatory documents as Chair of the EMWA-AMWA group who delivered the May 2016 open-access www.core-reference.org. Sam is long-time supporter of her professional association, the European Medical Writers Association (EMWA) www.emwa.org serving in various roles over 18 years, notably as Freelance Advocate; Editorial Board member for Medical Writing (MEW) (journal); Workshop Leader; Expert Seminar Series (ESS) Chair; and Vice President and President of the Executive Committee (EC). Sam was elected an EMWA Fellow in 2018 for her services to EMWA and the global MW community. Currently, Sam is MEW Section Editor for the “Regulatory Public Disclosure” Section, a Workshop Leader, and serves on the EMWA Regulatory Special Interest Group.
Online training – 2 modules
October 27th, 2021 9.30 am – 12.30 pm CEST
October 28th, 2021 9.30 am – 12.30 pm CEST
After the registration, you will receive all details about the connection.
The course will proceed with a minimum number of participants. Should this number not be reached the registered participants will be notified one week prior to the commencement of the course.
Early Bird: € 660,00* (until 1 October 2021)
Ordinary: € 850,00*
Freelance – Academy – Public Administration**: € 430,00*
* for Italian companies: +22% VAT
**Early Bird discount not applicable to Freelance – Academy – Public Administration fee
The fee includes: tuitions, organizational office assistance, teaching materials and attendance certificate that will be sent after the training via e-mail.
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Versione Stampabile
Cosa saprai fare dopo il corso
Online interactive training on Zoom platform.
LS Academy will provide the access link to the virtual platform a few days before the training.