Introduzione
The clinical study protocol is the reference document for any research describing all the information about the study and detailing its objectives, methodology, responsibilities, timing, and overall organisation.
This workshop will provide participants with the tools to:
- understand the elements behind the design of a clinical study,
- assess the quality of a protocol,
- use the guidelines to include all the necessary information to produce 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
Andrea has more than 30 years of experience in clinical research and physician relations. Author of more than 400 publications and articles, including more than 70 in peer-reviewed journals. He is past president, workshop leader, chairman of the study group on scientific communication and artificial intelligence, chair of the Italian group, and ambassador for the European Medical Writers Association (EMWA), of which he was president. In addition to his professional activities and training in medical schools, research centers, and medical-scientific societies, he acts as a speaker and chairman at several conferences.
This online training is divided in 3 modules:
Module 1 | 01 April 2025 from 9:30 am to 1:00 pm CEST
Module 2 | 02 April 2025 from 9:30 am to 1:00 pm CEST
Module 3 | 03 April 2025 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 11 March 2025)
Ordinary: € 1.160,00*
Freelance – Individual – Academy – Public Administration**: € 670,00*
*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
Versione Stampabile
Cosa saprai fare dopo il corso
Online interactive training on Zoom platform.
LS Academy will provide the access link to the virtual platform a few days before the training.