Introduzione
Mastering Clinical Study Protocols: Practical Skills for Clinical Study Design
Clinical study protocols are the foundation of every successful research project. They translate scientific objectives into operational plans, ensuring methodological rigor, regulatory compliance and ethical integrity throughout the study lifecycle.
Developing high-quality protocols requires a multidisciplinary approach that combines scientific expertise, regulatory knowledge and operational feasibility. From study design and endpoint selection to data management and transparency requirements, each element contributes to the overall quality and success of clinical research.
This highly interactive workshop provides participants with practical methodologies, international best practices, and operational tools for designing, reviewing, and improving clinical study protocols. Through real-world examples, group discussions and hands-on exercises, attendees will strengthen their ability to develop scientifically robust, operationally feasible and audit-ready protocols that support effective clinical research and cross-functional collaboration.
Programme
Foundations of Clinical Study Protocol Development
- The role of the clinical study protocol in ensuring scientific quality and regulatory compliance
- Regulatory and legal requirements in protocol development
- International guidelines, standards, and protocol templates
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- Workshop: Identify the standards
- Artificial Intelligence: opportunities, challenges, and practical applications
Designing Scientifically Robust Studies
- Study design principles and methodological approaches
- Defining objectives, endpoints, and outcome measures
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- Workshop: Identifying the objective of a study
- Assessing study feasibility and potential development pathways
- Sample collection, management, and data quality considerations
Ethics, Transparency and Governance
- Ethical principles in clinical research and protocol development
- Transparency requirements and data publication strategies
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- Workshop: Which results have to be disclosed?
- Conflicts of interest, authorship, and administrative responsibilities
- Auditing processes and quality assurance considerations
Building Effective Cross-Functional Collaboration
- Understanding the roles and responsibilities within multidisciplinary study teams
- Managing information flows and decision-making processes
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- Workshop: Who has the information?
- Best practices for successful collaboration throughout protocol development
Participants will be requested to actively participate in the Interactive Workshops and apply the output to their needs in an ongoing project.
The workshop is aimed at all personnel working in structures involved in the development, review or management 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 producers, 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.
The course combines interactive lectures, real-world examples, and hands-on workshops to provide participants with practical tools and methodologies they can apply immediately in their professional activities.
Docente/i
Andrea Rossi
Andrea has more than 35 years of experience in clinical research and physician relations. He has authored more than 400 publications, including over 75 peer-reviewed papers. A former President of the European Medical Writers Association (EMWA), Andrea has led numerous training initiatives, workshops, and conferences on medical writing, scientific communication, and artificial intelligence in research.
He regularly collaborates with pharmaceutical and medical device companies, universities, medical schools, research centers, and scientific societies across Europe.
This online training is divided in 3 modules:
Module 1 | 20 May 2027 from 02:00 pm to 05:30 pm CEST
Module 2 | 25 May 2027 from 02:00 pm to 05:30 pm CEST
Module 3 | 27 May 2027 from 02:00 pm to 05:30 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: € 975,00* (until 29 April 2027)
Ordinary: € 1.175,00*
Freelance – Individual – Academy – Public Administration: € 685,00*
*for Italian companies: +22% VAT
The fee includes: tuition, organizational office assistance, teaching materials and attendance certificate that will be sent after the training via e-mail.
Newsletter
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.
