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 draw up an effective clinical study protocol.
- The basics of protocol writing: Regulatory needs
- Studies in the context of the COVID-19 pandemic
- 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 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 30 years of experience in clinical research and physician relations. He is the author of more than 400 publications and articles, including more than 70 in peer-reviewed journals. He has also managed and written most regulatory documents and coordinated the medical writing activities of regulatory submissions.
He is the 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, Universities, research centers, and medical-scientific societies, he is a speaker and chairman at several conferences.
Online Training – 3 modules
MODULE 1 | 06 October 2021 from 9.30 am to 1.00 pm CEST
MODULE 2 | 07 October 2021 from 9.30 am to 1.00 pm CEST
MODULE 3 | 08 October 2021 from 9.30 am to 1.00 pm CEST
After the registration, you will receive all details about the connection.
The course admits maximum 12 attendees.
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 2021)
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.
Newsletter
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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.