KD-CAAP Protocol Training

Edition of the course: 1st Edition

Course starting date: 21st October 2020

Course duration: 1 hour

Course enrollment: Enrollment is open for the duration of the trial

If you are involved in KD-CAAP Trial, and would like to enrol, please contact your National Hub.

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

Once you receive this password from your National Hub, please log in on  c4c Academy Platform.

If you do not have an account yet, click on Create new account and follow the instructions.


General Description:

This course will be used to train and give the attendee an overall understanding of the KD-CAAP study and give an understanding of the protocol and rational for completing the trial. Including:

  • Study procedures, Reporting Protocol deviations, TMF.
  • Informed consent process
  • Randomisation procedures
  • Source documentation requirements,
  • Safety Management
  • Adverse event reporting procedures
  • Investigators responsibilities for expedited reporting of SAEs and SUSAR
  • Administrative and budgetary details.
  • Frequency of and expectations for any monitoring visits.



The course is structured as a slide show presentation with an accompanying recording containing additional information.


Resource 1: slide set with an associated recording on each of the topics mentioned above

Activity 1: Confirm they have understood the training by completing a question:

I confirm that I have completed and understood the training’

Certificate to confirm the training has been completed

Survey: to collect any feedback on the training provided


Who is the course for?

All site staff involved in the completion of trial site related tasks.


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


Bloom’s taxonomy level of the course:


Despina Eleftheriou

and Cara Purvis



Cara Purvis

Helen Webb

Ben Forson

Despina Eleftheriou

Paul Brogan