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 organization.

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 draw up an effective clinical study protocol.

  • The basics of protocol writing: Regulatory needs
  • Studies in the context of the COVID-19 pandemic
  • 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 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 centers 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.

Online Training – 3 modules

04 October 2022 from 9.30 am to 1.00 pm CEST
05 October 2022 from 9.30 am to 1.00 pm CEST
06 October 2022 from 9.30 am to 1.00 pm CEST

After the registration, you will receive all details about the connection.

The course admits maximum 12 attendees.

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: € 925,00* (until 06 September 2022)

Ordinary: € 1.125,00*

Freelance – Academy – Public Administration**: € 600,00*

* 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.

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Versione Stampabile
Cosa saprai fare dopo il corso
Risultato atteso
Identify the study protocol contents and their importance
Risultato atteso
Have the basic concepts for writing a clinical study protocol
Risultato atteso
Identify the study team for protocol development
Risultato atteso
Avoid the most common errors when a clinical study protocol is developed
<p>Online interactive training on Zoom platform.</p> <p><em>LS Acade</em><em style="font-size: 1rem;">my 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>Online interactive training on Zoom platform.</p> <p><em>LS Acade</em><em style="font-size: 1rem;">my will provide the access link to the virtual platform a few days before the training.</em></p>
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Clinical Study Protocols