Enrolment open from 6th Nov 2023 to 14 Jan 2024

Title of Course: Elements of Clinical Trials Methodologies

Edition of the course: First Edition

Course Category: Interactive 

Course Duration: 10 hours (including attending video lessons, webinar and journal club)

Course start date: 15 Jan 2024

Course end date: 14 Apr 2024

Course enrollment: Enrollment is open from 6th Nov 2023 to 14 Jan 2024

To enrol in this course, please contact your National Hub who will supply you with the course password.

Your National Hub’s Referent Person for Training and Education will verify your eligibility to enroll to the Course and provide you with the Course’s enrolment password.

Once you receive this Course’s Enrolment Password from your National Hub, please log in on c4c Academy Platform.

If you don’t have an account yet, click on Create new account and follow the instructions.

All the students are enrolled for part 1 and part 2 at the beginning of the course.

General Description:

The scope of the course “Elements of Clinical Trials Methodologies” is to provide the basic elements of clinical research methodologies giving high relevance to the understanding of clinical research results and learning the basics of writing research papers. Reading, understanding, and writing papers are fundamental activities for researchers who want to properly use clinical methodologies in their own research.


The course is divided in two parts:


  • Part 1 (Self-Paced learning & Self-Assessment)
    Part 1 is for the individual student and consists of 5 modules. Each module includes pre-recorded video lessons and the set of slides to download. The students can ask questions to the trainers in the online forum. A self-assessment quiz is available right after the student has followed the lessons. 5 weeks of time to follow all the lessons.

    Module 1: General concepts about clinical trials
    1.1Definition and scope of a clinical trial
    1.2Setting the research question
    1.3Clinical Trial Design
    1.4Designing a clinical trial protocol
    1.5Who does what? Roles and responsibilities in a clinical trial
    1.6Why pediatric clinical trials are needed?
    1.7What are the challenges of a pediatric clinical trials?
    Module 2: The practical aspects of clinical trials
    2.1Patient screening, recruitment, and retention
    2.2Data analysis & interpretation – part 1
    2.3Data analysis & interpretation – part 2
    2.4Not only about medicine: admin, time management and economics of a clinical trial
    Module 3: The rules and ethics 
    3.1Health authorities and ethical aspects
    3.2Patient consent & assent
    3.3Adherence to the protocol, safety, and reporting
    3.4Doctor-patient communication in a clinical trial
    Module 4: Reading and critiquing a research paper on a clinical trial
    4.1Why reading research articles is important?
    4.2Reading the paper: understand the question
    4.3Interpreting the results and linking the different studies
    Module 5: Writing a research paper on a clinical trial
    5.1How to write the abstract of your paper
    5.2Write the methods and the results
    5.3Write your interpretation of the results
    5.4How to write a cover letter
  • Part 2 (Online Meeting and Working Groups)
    Part 2 starts with an online webinar during which the trainers will give a short summary of the topics of part 1 and will be available for questions and comments from students. The students are divided in groups and a research paper is assigned to each group. Each group is asked to prepare the abstract and a short presentation of the assigned paper. 4 weeks after the webinar, there will be journal club during which each group will present the paper.


  • Conclusion
    The students will fill in an evaluation survey and receive a certificate of attendance.The certificate issued with completion of the self-assessment quiz, journal club attendance and completion of the evaluation survey


Part 1 Start Date: 15 Jan 2024
Part 2 Webinar: 15-20 Feb 2024 (date to be confirmed)
Journal Club: 15-31 March 2024 (To be confirmed)
End Date: 14 Apr 2024 


Who is the course for?

The main audience of this course includes all the people who are in c4c national hubs and who are involved in the delivery of clinical trials and who are interested into the topic. These include young investigators (associate), research nurses, clinical trial pharmacists, study coordinators, data managers & biostatisticians.

The course ‘Elements of Clinical Trials Methodologies’ does not require a high level of expertise: it is for an audience with different background (they are not necessarily all doctors) and it is preparatory to the more advanced courses in the c4c platform (e.g., Innovative Trial Design).

An ideal audience is represented by the young investigator community of c4c (https://conect4children.org/young-investigators ). Young investigators/research professionals are from the National Hubs, involved in research and clinical trials and are below the age of 45 years. Although in the early stages of their research careers, these young investigators/researchers will hopefully be among the future leaders in pediatric clinical trials in Europe and beyond.


Max. number of persons that can enrol: 40 (20 persons must enrol for the course to take place)


Bloom’s taxonomy level of the course:

Blooms Taxonomy level 5


  • Francesca Rocchi, OPBG, Italy // rocchi@opbg.net

  • Fiona Dunlevy, ECSF, Denmark fiona.dunlevy@ecfs.eu

  • Manuela Stella, Gaslini Hospital, Italy manuelastella@gaslini.org

  • Nicola Ruperto – Gaslini Hospital, Italy nicolaruperto@gaslini.org

  • Anando Sen, Newcastle University, UK Anando.Sen@newcastle.ac.uk