The study protocol plays a crucial role in research success, outlining standardized procedures for effective communication among stakeholders.

Unlike clinical trials, real-world evidence studies lack interventions, relying on patient data from routine clinical care.

Developing non-interventional study protocols requires specific considerations to ensure accuracy and relevance.

The aim of the course is to provide an overview of the standards and definitions needed for writing and publishing an observational study protocol.

Module 1: Study Design

  • How to write a good research question
  • Study Designs: definitions and properties
  • Definition of Exposures and Outcomes
  • Standards for writing an observational study protocol

 Module 2 : Statistical Analysis & Data Dissemination

  • Sample size in observational studies
  • Indicators used for the observational research
  • Confounders
  • Workshop
  • Standards for publishing an observational study protocol

Roles in Medical Affairs, Clinical Research, Real World Evidence Generation who must generate pre- and post-marketing Real World Evidences to support corporate product development.

Participant experience 

Basic knowledge on the definition of Observational Studies, basic knowledge of descriptive statistics

Interactive lessons with a final workshop for study protocol writing.

Lucia Simoni

Lucia Simoni

Associate Director Epidemiology, Biostatistics, Data Mgm & Scientific Director, MediNeos IQVIA

Lucia oversees and coordinates the activities of Clinical Data Management, Biostatistics and Epidemiology of Real-World Evidence studies with 20+ years of experience.
She is responsible for ensuring the highest possible quality control in recorded clinical data and for developing strategies to optimize such processes.
She joined Medineos in 2001 as biostatistician. Since 2003 she manages the team of  Clinical Data Management, Biostatistics and Epidemiology.
She  has deep experience in designing observational studies and thanks to her experience she balances the best methodological solutions with study feasibility.
She is author of several scientific publications and lectures both at national and international congresses. Moreover, she is speaker in webinars and training courses on real-world data generation and the methodology of  observational studies.
She was member of the Directive Committee of SISMEC (Italian Society of Medical Statistics).
She is expert in the validation process of Patient-Reported Outcomes.
Education: MS degree in Statistics and a PhD in Population Genetics from the University of Bologna. Moreover she completed a 2-year post-doctorate fellowship at University of Geneva.

Online Training – 2 modules

Module 1 | 20 November 2024 from 2:00 pm to 6:00 pm CET
Module 2 | 25 November 2024 from 2:00 pm to 6:00 pm CET

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: € 845,00* (until 30 October 2024)

Ordinary: € 1035,00*

Freelance – Individual – Academy – Public Administration**: € 550,00*

* for Italian companies: +22% VAT

** Early Bird discount not applicable to Freelance – Academy – Public Administration fee

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

Mara Claudia Algarotti
Mara Claudia Algarotti
Training Manager & MW Operations
Versione Stampabile
Cosa saprai fare dopo il corso
Risultato atteso
Identify the most appropriate methods for designing real world evidence projects
Risultato atteso
Identify the potential and limitations of evidence from observational studies
Risultato atteso
Discuss Real World Evidence topics competently with internal and external stakeholders
Risultato atteso
Review the characteristics of an observational study manuscript

<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>