Enrolment will be open from 21st Aug to 17th Sept 2023*.

* plus, an “extraordinary enrolment phase” from 18th Sept to 1st Oct 2023.


Title of Course: Essential Documents

Edition of the course: Pilot Edition

Duration: 7- 8 hours

Start date: 2nd Oct 2023

End date: 3rd Nov 2023

Enrollment Dates: Enrollment is open from 21st Aug to 17th Sept 2023; plus, an “extraordinary enrolment phase” from 18th Sept to 1st Oct 2023.

Please see enrolment procedure below!
Once enrolled and you have received your password, please log in on c4c Academy Platform to begin your course.
If you don’t have an account yet, click on “Create new account” and follow the instructions.

 


General Description:

The course is designed to familiarise you with the essential documents needed for a Clinical Trial, following the guidelines of Good Clinical Practice. You’ll start with some informative study material, and then dive into three engaging and interactive animated video-lessons.

Videos cover in chronological order the essential documents that must be present at each stage of the trial i.e.:

  1. Before the trial begins

  2. During the trial

  3. After the trial is completed.

During the 4th week, a webinar will be organized which will require participation from all the students and the faculty.

An online discussion forum will be available throughout the course to allow students to interact with the teachers.


Programme:

  • Week 1: Study of background material provided by the teachers;

  • Week 2 and 3: Interactive animated video-lessons;

  • Week 4: Webinar on the c4c Academy Platform;

  • Week 5: Final exam and certification.

An online dicussion forum is active throughout the course

 

Certification:

Having successfully passed a final examination and completed a satisfaction questionnaire, students will obtain an attendance certificate by the c4c Educational Board.


Who is the course for?

Health care professionals involved in clinical trials regarding neonates, children and adolescents


Max. number of persons that each national hub can enrol: 20

There is also a minimum requirement of 10 for the course to proceed.

 

Bloom’s taxonomy level of the course:

Faculty:

  • Loic Notelet (loic.notelet@sanofi.com)

  • Pernille Skovby (pernille.skovby@region.dk)

  • Teresa Berkery (t.berkery@ucc.ie)

  • Melissa Walsh (melissa.walsh@ucc.ie)

 

Enrolment:

The enrolment procedure is as follows:

  • The course is open for enrolment between  21st Aug to 17th Sept 2023.

  • Each National Hub can select 1 CANDIDATE (who meets the eligibility criteria) and give them the course’s enrolment password.

  • The selected candidates must enrol in the course before the enrolment deadline (i.e. 17th Sept 2023)

  • After the enrolment deadline – and if there are vacant places (the enrolled persons are less than 20) – c4c Academy Management Secretariat will inform the National Hub’s Referent Persons for Training and Education that there are “xx” spots available to enroll to the course.

  • At this point there will be an “extraordinary enrolment phase” from the 18th Sept to 1st Oct 2023.

  • The National Hubs can, at this point, enroll participants with no number limitations, until the max. total number of 20 is reached. Vacant places will be assigned based on a precedence criteria (who enrolls first gets the spot).

  • Once 20 participants have enrolled, it will not be possible to join the current edition of the course.

  • If the minimum number of 10 participants is reached the course will not be carried out.