Enrolment will be open from 21st November to 11th December 2022*

* plus, an “extraordinary enrolment phase” from 12 December 2022 to 15th January 2023


Name of the course: Audit & Inspection Readiness

Edition of the course: Third Regular Edition

Enrolment Dates: 21st Nov to 11th Dec 2022 (plus an “extraordinary enrolment phase” from 12th Dec 2022 to 15th Jan 2023)

Starting date of the course: 16th Jan 2023

Closing date of the course: 17th Feb 2023

Course duration: 7-8 hours

 

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 focuses on how and inspection (or an audit) should be prepared and conducted by the staff of a Clinical Trial site. At the beginning of the course some study material is provided to the students. The course then proceeds with two interactive animated video-lessons. In the first screenplay a situation is set before an inspection; in the second one the situation is set during the inspection. During the whole course students can interact with teachers with an asynchronous forum hosted on the c4c VLE platform. A webinar will be organized during the 4th week of the course with the participation of all the students and the faculty. Having successfully passed a final examination and having answered to a satisfaction questionnaire, students will obtain an attendance certificate by the c4c Educational Board.

 

Programme:

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

  • Week 2 & 3: Interactive animated video-lessons.

  • Week 4: Webinar on the c4c VLE Platform.

  • Week 5: Final exam and certification

An asynchronous forum is active during the whole course


Who is the course for?

The course is for health care professionals involved in clinical trials regarding neonates, children and adolescents.


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

1 per each National Hub 
There is also a minimum number of 10 students to activate the course.
(If, at the end of the “extraordinary enrolment phase” this number has not been reached, the course will not be carried out)

 

Bloom’s Taxonomy Level of the Course: 3, 4 and 5

Faculty:

    • Loic Notelet

    • Mariagrazia Felisi

    • Ana Dilo

    • Pavla Pokorna


Enrolment Procedure: 

The enrolment procedure will work like this:

  • The regular enrolment time frame starts on 21st Nov and ends on 11th Dec, 2022

  • Each National Hub can select ONLY 1 CANDIDATE (who meets the eligibility criteria) and give him/her the Course’s Enrolment Password. 

  • The selected candidates enroll to the Course within enrolment’s deadline – it expires on 11th Dec)

  • Once the enrolment deadline expires – ONLY 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” – which will start on 12th Dec 2022 and it will expire on 15th Jan 2023

  • The National Hubs can enroll participants to reach the max. total number of 20: the vacant places will be assigned based on a precedence criteria (who enrolls first gets the spot).

  • After the max. number of people that can be enrolled has been reached, it will not be possible to join the current edition of the course.

  • If, at the end of the “extraordinary enrolment phase”, the number of enrolled students will be less than 10 the course will not be carried out.

  • The course will start on 16th Jan 2023 and it will end on 17th Feb 2023.