Introduzione

Clinical Study Reports (CSRs) are critical documents by which regulators can assess the outcome of clinical studies.

This virtual course in 2 sessions covers scheduling, managing, and authoring CSRs for clinical studies on drugs, biologics, and medical devices. CSRs for submission to the Health Authorities must also comply with the International Conference on Harmonization (ICH) standards and meet high-quality standards.

Participants will learn the elements of the CSRs and the appendices, methods for turning the protocol and statistical outputs into one cohesive document, the basics of writing and preparing a document for submission, and the guidance to follow for reference. The course will provide the latest strategies for scheduling and preparing clear, well-organized, ICH-compliant CSRs more efficiently.

At the end of this course, participants should understand the resources and timelines and have gained the knowledge to schedule, manage, write, and deliver drafts through final version CSRs of the highest quality and fully ICH compliant. By completing the course, participants will also gain insight into the public disclosure requirements a CSR must fulfil.

  • Welcome and objectives
  • Review of the participant needs
  • Introduction
  • Workshop: Write or communicate?
  • Regulatory requirements
  • Transparency and Public Disclosure requirements
  • Study Documents I Read Before Writing a CSR
  • Components and Stages of Preparation of the Integrated CSR (Shell CSR, Draft CSR and Final CSR)
  • The structure of CSR
  • Title page, abbreviations, definition of terms, ethics, investigators
  • Introduction, study objectives, investigational plan, study patients, efficacy evaluation, safety evaluation
  • Discussion, overall conclusions, tables, figures, graphs
  • Appendices
    • Patient narratives
    • Appendices management
  • Workshop: What do I need to write a CSR?
  • The synopsis
  • Changes to approved clinical study reports
  • Workshop: where is the info?
  • Final discussion, outstanding questions participants, and closing remarks

This 6 hours course is intended for professionals in the biomedical field, including, but not limited to, employees of Biotech and/or Medical Device companies, Pharmaceutical companies, CROs, Consultants, Research hospitals, and Universities, as:

  • Medical Writers
  • Clinical Study Managers
  • Regulatory Professionals
  • Clinical Operations Professionals
  • Scientists and representatives of academia running clinical trials
  • Biostatisticians
  • Physicians

who are involved in clinical research and need to write CSR.

Participant experience

The course is designed for anyone who knows the basics of clinical research and scientific publishing and needs to report a clinical trial’s outcomes.
This course will also benefit participants who have written or reviewed at least one CSR and have a working knowledge of ICH reporting guidelines.

This online course will be highly interactive. Discussion and questions will be integral to the virtual sessions, and participants will be actively involved.

Docente/i
Andrea Rossi
Info

Andrea Rossi

Consultant in Medical Writing, Communications and Scientific Affairs

Andrea has more than 30 years of experience in clinical research and physician relations. He is the author of more than 400 publications and articles, including more than 70 in peer-reviewed journals. He has also managed and written most regulatory documents and coordinated the medical writing activities of regulatory submissions.

He is the past president, workshop leader, chairman of the study group on scientific communication and artificial intelligence, chair of the Italian group, and ambassador for the European Medical Writers Association (EMWA), of which he was president. In addition to his professional activities and training in medical schools, Universities, research centers, and medical-scientific societies, he is a speaker and chairman at several conferences.


Online Training – 2 modules:

MODULE 1 | 25 September 2025 from 2:30 pm to 5:30 pm CEST
MODULE 2 | 29 September 2025 from 2:30 pm to 5:30 pm CEST

Some days before the online training 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: € 680,00* until 04/09/2025

Ordinary: € 870,00*

Freelance – Individual – Academy – Public Administration: € 495,00*

*for Italian companies: +22% VAT

The fee includes: tuition, organizational office assistance, teaching materials and attendance certificate that will be sent after the training via e-mail.

Registrati
Early bird
Acquistabile fino al 04/09/2025
680,00
Ordinaria
Acquistabile fino al 24/09/2025
870,00
Freelance - Privato - Accademia - Pubblica Amministrazione
Acquistabile fino al 24/09/2025
495,00
Svuota

Versione Stampabile
Cosa saprai fare dopo il corso
Risultato atteso
Develop a comprehensive and easily reviewable clinical study report
Risultato atteso
Understand the stages involved in authoring CSRs, allowing you to make a valuable contribution to your organisation’s process improvement activities
Risultato atteso
Be better equipped to manage stakeholder expectations with regard to efficient, effective, and realistic CSR scheduling

<p><span>Online interactive training on Zoom platform. </span></p>
<p><em>LS Academy will provide the access link to the virtual platform a few days before the training.</em></p>

Online interactive training on Zoom platform. 

LS Academy will provide the access link to the virtual platform a few days before the training.

<p><span>Online interactive training on Zoom platform. </span></p>
<p><em>LS Academy will provide the access link to the virtual platform a few days before the training.</em></p>