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WEBINAR: Writing a Clinical Trial Protocol
Which information goes in a protocol. How should we write this information and who is involved
Writing a clinical trial protocol represents a major challenge. It is a document that:
- May change a lot in terms of content and format according to the study design
- Involves many different roles
- Needs to fulfill with many different directives and regulations
Still, it is extremely important that it is clear and understandable, readable, precise and coherent, both within the text and towards the related pre-study documentation.
This webinar aims at giving participants the basics to plan the writing of a clinical protocol, to take part in its preparation and to analyze the critical steps involved.
- What is the research question?
- What is a clinical trial protocol and why do I need it?
- The basics of writing a clinical protocol: guidelines and regulations
- Writing a clinical protocol:
What type of study?
Who is going to read each chapter?
Which chapters are related to one another?
- One single document, many roles involved
- Frequent mistakes to be avoided
Templates and checklists
- Data sharing: clinical research registries
The course will be in Italian.
After a PhD in bioinformatics, he landed in the world of clinical research in 2004, at the GIMEMA Foundation. There, he was involved in different roles in the management of clinical studies. In recent years he has delved into the subject of clinical study registers and scientific communication. He recently created the GIMEMA News web portal, dedicated to blood diseases, of which he is now the director. He is also the founder and scientific director of the sperimentazionicliniche.it web portal, devoted to clinical research and related online communication.
Project Managers, Clinical Study Managers, Clinical Research Associates/Consultants, Medical Managers, Medical Writers, Regulatory, Data Managers of pharma companies, CROs, Research Centres and Universities applied sciences and biotechnology faculties.
Participants should already be familiar with basics of clinical research.
This Webinar online in divided in 3 modules:
- Module 1 | 09 June 2020 from 14:30 pm to 16:30 pm
- Module 2 | 16 June 2020 from 14:30 pm to 16:30 pm
- Module 3 | 23 June 2020 from 14:30 pm to 16:30 pm
Some days before the webinar 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: € 540,00* (until 19 May 2020)
Ordinary: € 615,00*
Freelance - Academy - Public Administration**: € 324,00*
* for Italian companies: +22% VAT
** Early Bird discount not applicable to Freelance - Academy - Public Administration fee
The fee includes: Access to the webinar, teaching materials in pdf format provided post-webinar, organizational office support, certificate of attendance.
Tuesday, May 19, 2020
At the end of the training, you will be able to
Understand what a clinical protocol is and why it is needed
Understand the rationale beneath its planning and design
Define the chapters that need to be included in a clinical protocol
Manage the collaborative writing of it
Avoid common mistakes