Discover the course

WEBINAR: Writing a Clinical Trial Protocol

Which information goes in a protocol. How should we write this information and who is involved

Date

09-16-23 June 2020

Location

Webinar

Language

Italian

WEBINAR: Writing a Clinical Trial Protocol

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 webinar 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


Course Language

The course will be in Italian.

Giulio D'Alfonso
Giulio D'Alfonso Responsible Director of GIMEMA informazione, GIMEMA “Franco Mandelli” Foundation

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.


Participant experience

Participants should already be familiar with basics of clinical research.

Webinar

WEBINAR

This Webinar online in divided in 3 modules:


- Module 1 | 09 June 2020 from 14:30 pm to 16:30 pm

- Module 2 | 16 June 2020 from 14:30 pm to 16:30 pm

- Module 3 | 23 June 2020 from 14:30 pm to 16:30 pm


Some days before the webinar 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.

Certificate of attendance

WEBINAR

Early Bird: € 540,00* (until 19 May 2020)

Ordinary: € 615,00*

Freelance - Academy - Public Administration**: € 324,00*


* for Italian companies: +22% VAT

** Early Bird discount not applicable to Freelance - Academy - Public Administration fee


The fee includes:  Access to the webinar, teaching materials in pdf format provided post-webinar, organizational office support, certificate of attendance.

Register now

Course Price

615.00 €

Early Bird

Tuesday, May 19, 2020

540.00 €

Payments accepted

  • Bank Transfer
  • Credit Card
  • PayPal

Other Details

Duration

3 modules (2 hours each)

Course Type

Limited number of participants

You will receive

Certificate of attendance

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

Participants' Feedbacks

Now have more structured approach to writing on article

Practical evaluation of how to approach risk analysis

It is not a frontal lesson but an interactive one

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WEBINAR: Writing a Clinical Trial Protocol

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Terms & Conditions

Trainings
The fee includes: tuition, teaching materials, lunches and coffee breaks, organizational office assistance, attendance certificate. Early Bird discount not applicable to Freelance – Academy – Public Administration fee.
The course will proceed with a minimum of 8 participants. Should this number not be reached the registered participants will be notified one week prior to the commencement of the course.
For further information please contact:  e-mail: training@LSAcademy.com  telephone: +39 (0)35.515684

Conferences
The fee includes: seat at the conference, copy of presentations of Speakers who allow the distribution, informative literature for the day, networking lunch, coffee break, organisational office assistance, certificate of attendance. For further information please contact:  e-mail: events@LSAcademy.com  telephone: +39 (0)35.515684

Webinars
The fee includes: tuition, teaching materials, organizational office assistance, attendance certificate. Early Bird discount not applicable to Freelance – Academy – Public Administration fee. For further information please contact:  e-mail: training@LSAcademy.com  telephone: +39 (0)35.515684

Common Terms & Conditions

Terms of payment
Payment should be made online (by credit card) or by bank transfer, at the time of registration (only for Italian companies: + 22% VAT) to EasyB s.r.l by bank transfer or by credit card. Bank transfer payable to:

EasyB S.r.l.
Via Roma, 20 – 24022 Alzano Lombardo (Bergamo)
VAT: IT03633040161
BANCO BPM – Filiale di Carobbio degli Angeli
IBAN: IT81 F 05034 53960 000000003450
SWIFT Code: BAPPIT21AY5

Confirmation of event admission will be given on receipt of payment. Invoice will be sent following receipt of payment. EasyB reserves the right to refuse late registrations or additional registrations above the maximum accepted number of participants or registrations of roles that are not included in the target of the event.

Cancellation
Please note that refunds (50% refund of the registration fee) will only be given if cancellation is received at least four weeks before the event date. Cancellations will only be valid if made in writing. Transfer of registrations (or name changes) are allowed for free and should be made in writing within 7 days prior to the event. EasyB reserves the right to postpone or cancel an event, to change the location of an event or to alter the advertised speakers for an event, to change its performance from residential to webinar/online. EasyB is not responsible for any loss or damage as a result of substitution, alteration, postponement or cancellation of an event due to causes beyond its control including without limitation, acts of God, natural disasters, sabotage, accident, trade of industrial disputes, terrorism, hostilities, epidemics, pandemics, and / or authorities’restrictions (so-called factum principis).

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