Introduzione
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 build an effective clinical study protocol.
- The basics of protocol writing: Regulatory needs
- 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 Liaison, 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.
Workshop.
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 | 04 October 2023 from 9:30 am to 1:00 pm CEST
Module 2 | 05 October 2023 from 9:30 am to 1:00 pm CEST
Module 3 | 06 October 2023 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: € 925,00* (until 13 September 2023)
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.
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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.