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.

  • Welcome and objectives
  • Introduction
  • Regulatory needs, study registration, and disclosure of the results
  • Transparency of clinical studies
  • Guidelines
    • clinical trials on drugs
    • clinical investigations on medical devices
  • Studies in the context of the COVID-19 pandemic
  • The structure of the protocol
  • Title, sponsorship, contributorship, study committees
  • Introduction, objectives, treatments, and comparators
  • Study design, methods:
    • setting
    • inclusion/exclusion criteria
    • therapies/devices
    • concomitant therapies
    • efficacy/results
    • safety
    • sample size
    • recruitment
    • randomisation/blinding
  • Data collection and management
  • Evaluation of the outcomes
    • primary and secondary outcomes
    • missing data
    • monitoring
  • Interim analyses
  • Adverse events
  • Auditing
  • Ethical aspects
    • approvals
    • amendments
    • informed consent
    • confidentiality
  • Possible study development
    • access to data
    • post-trial assistance
    • study replication
  • Disclosure of the results
    • planning
    • needs
  • Conflicts of interest
  • Authorship
  • Samples collection and management
  • Workshop: who has the information?
  • Final remarks

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.


Andrea Rossi

Andrea Rossi

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

Online Training – 3 modules

MODULE 1 | 06 October 2021 from 9.30 am to 1.00 pm CET

MODULE 2 | 07 October 2021 from 9.30 am to 1.00 pm CET

MODULE 3 | 08 October 2021 from 9.30 am to 1.00 pm CET


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 7 September 2021)

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.

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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