Preparing research staff
Training research staff
In addition to other requirements, including the BROK training for clinical researchers and a recognised WMO/GCP course for research support staff (e.g. research nurses, study coordinators), all individuals involved in the study must know what their obligations and tasks are with regard to the study and the subjects. In addition, the research team should always be informed and trained on the latest version of the protocol and all study-specific actions and procedures.
It would therefore be wise to organise a central kick-off meeting or initiation meeting for those involved, before your research starts, in order to discuss these matters properly.
A training log can be used to keep track of which members of the study team have been trained, what they have been trained on and by whom. Only after a study team member has been fully trained, he or she is authorized to perform study activities. Therefore, the date of training must be before the start date of the relevant study team member tasks, noted on the delegation log.
EPIC: Roles and authorisations
For each approved study, the MREC secretariat creates a study record (the electronic patient file) in EPIC. The study record can then be supplemented and activated, so that inclusion can start.
It is important to verify that those involved in the investigation have the proper EPIC authorisations for their tasks and that they have been adequately trained. The EPD website for the Amsterdam UMC Service Centre (EvA) provides the necessary documentation, instructions and information in the form of tip sheets and videos. All of the tip sheets for research are listed on this page.