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.
Programme:
The course is structured as a slide show presentation with an accompanying recording containing additional information.
Introduction
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:
Faculty:
Despina Eleftheriou
and Cara Purvis
Supervisors
Cara Purvis
Helen Webb
Ben Forson
Despina Eleftheriou
Paul Brogan