Introduzione

The clinical study protocol is the reference document for any research describing all the information on the study, detailing its objectives, methodology, responsibilities, timing, and overall organisation.

This workshop, aimed at all those involved in the development of the protocol, will provide participants with the tools to understand the elements behind the design of a clinical study, evaluate the quality of a protocol, and use the guidelines to include all the necessary information to build an effective clinical study protocol.

  • The basics of protocol writing: Regulatory needs
  • Guidelines and templates
  • Study design and methods
  • Evaluation of the outcomes
  • Auditing
  • Ethical aspects
  • Transparency and data publication
  • Possible study development
  • Conflicts of interest
  • Authorship and administrative responsibilities
  • Samples collection and management
  • Workshop: who has the information?

The workshop is aimed at all personnel working in structures involved in the development of a clinical study protocol, including Project Managers, Clinical Study Managers, Clinical Research Associates / Consultants, Medical Liaisons, Medical Directors, Pharmacovigilance, Legal, Medical Managers, Medical Writers, Regulatory, Data Managers, Statisticians of pharmaceutical companies, of devices or diagnostics, CROs and also to the staff of hospital/university or private research centres who need to write or participate in the creation of clinical study protocols.

Participant experience
Basic knowledge of clinical trial design and management.

Workshop

Docente/i
Andrea Rossi
Info

Andrea Rossi

Consultant in Medical Writing, Communications and Scientific Affairs
Andrea Rossi is a Medical Writing, Communications, and Scientific Affairs Consultant. After a brief spell at the University of Florence as a biologist, he started working as a Clinical Research Associate in the Italian Affiliate of Eli Lilly. In the years that followed, he was responsible for Statistics, Health Outcomes, and Medical Information. Andrea has been working as a Medical Writer since 2003, beginning in Italy and then increasing his responsibilities until he became worldwide responsible for a biosimilar company based in Switzerland, giving him vast experience in any aspect of clinical trials. He is the author of more than 350 disclosures and is acknowledged for contributing to several others. From 2007 to 2009, he was on the coordination board of BIAS (Biometristi Italiani Associati) and has been a European Medical Writers Association (EMWA) member since 2004. Andrea is a statistics and medical writing trainer in some Italian schools for specialisation in medicine and has acted as a speaker at national and international conferences. Andrea leads workshops, the Special Interest Group on Medical Communications, and is past president and ambassador of EMWA.

This online training is divided in 3 modules:

Module 1 | 03 April 2024 from 9:30 am to 1:00 pm CEST
Module 2 | 04 April 2024 from 9:30 am to 1:00 pm CEST
Module 3 | 05 April 2024 from 9:30 am to 1:00 pm CEST

The course admits maximum 12 attendees.

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: € 950,00* (until 20 March 2024)

Ordinary: € 1.160,00*

Freelance – Academy – Public Administration**: € 620,00*

*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.

Registrati
Early bird
Acquistabile fino al 20/03/2024
€950,00
Ordinaria
Acquistabile fino al 02/04/2024
€1.160,00
Freelance - Accademia - Pubblica Amministrazione
Acquistabile fino al 02/04/2024
€620,00
Svuota
Versione Stampabile
Cosa saprai fare dopo il corso
Risultato atteso
Identify the study protocol content and its importance
Risultato atteso
Know the basic concepts for writing a clinical study protocol
Risultato atteso
Identify the study team to develop a protocol
Risultato atteso
Avoid the most common errors and mistakes
<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>
Vedi tutte le edizioni
Clinical Study Protocols