Discover the course
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 training 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.
Via Masaccio 19
20149 – Milano
Melia Milano is perfectly located in the most dynamic and fastest-growing district in Milan, a short walk from CityLife, a new architectural project with a shopping centre and urban garden. The historical city centre of Milan is just 15 minutes away using the nearby subway.
2 minutes walking from the metro station Lotto (M1 red line or M5 violet line)
Milan Linate airport, 12 km from Hotel Melià, is the most closest airport to the city and can be easily reached by car, bus or train
Central Station 6 km, Cadorna Station 3,5 km, Garibaldi Station 4 km
Garage Masaccio (30 mt), Garage Lotto (350 mt), Parcheggio San Siro (300 mt)
In addition to the hotel venue here is some recommended hotels for accommodation in the nearby:
Hotel Oro Blu (at 230 mt)
Hotel Portello (at 450 mt)
Hotel Montebianco (at 270 mt)
Ristorante Pizzeria La Primula, Via Spagnoletto, 19 (11 minutes by walking). Or, in 15 minutes by metro you can reach the historic city center (“Duomo” metro stop) with various restaurants.
At your arrival you will find our Staff at the Welcome Desk to greet and make you feel welcome and as comfortable as possible, providing direction and all information about the meeting, seating, refreshments.
Coffee breaks and lunch will provide a pleasant moment of refreshment. Special care about the food quality, in particular to your dietary needs or preferences, from menus of local products and flavors to vegetarian dishes.
Limited number of participants to encourage networking and discussion.
All our training facilities are safe, healthy, comfortable, aesthetically-pleasing, and accessible. They are able to accommodate the specific space and equipment needs of the training program.
Depending on the seating configuration, the room may accommodate lecture-style instruction or encourage interaction in the form of roundtable discussions. Equipped for audio/visual, Free Wi-Fi to allow everyone to connect with just one click, electric sockets.
All the information necessary for learning during the course is provided. It is recommended to bring your PC to take notes (even directly on the slides provided in PDF format). The environment is important to us and that's why we try to make this meeting an experience of environmental sustainability.
Early Bird: € 790,00* (until 01 June 2020)
Ordinary: € 905,00*
Freelance - Academy - Public Administration: € 485,00*
* for Italian companies: +22% VAT
** Early Bird discount not applicable to Freelance - Academy - Public Administration fee
The fee includes: tuitions, teaching materials, lunches and coffee breaks, organizational office assistance, attendance certificate.
Monday, June 1, 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