Discuss in your group the content of a patient information (will you compensate the patients, what does the patient need to know regarding GDPR/DPO/DSO in this study, biobank..).

Patient Information
Discuss in your group the content of a patient information (will you compensate the patients, what does the patient need to know regarding GDPR/DPO/DSO in this study, biobank..). You find information about this on the EPM homepage. Which principles that must apply and how the process should be performed when obtaining the informed consent at the study site. Be prepared to get questions on this at the oral examination, but you do not have to document that you have had this discussion in the group.

The Project Plan
By applying the content of the materials you have studied during the complete course you will now plan the study in chronological order. Below you find some aspects you should take into consideration. The list below is not complete. It is up to your group to ensure all tasks are included to enable you to execute the study.
How many participating sites will be needed and which kinds?
Which approvals are required?
How will the study site personnel be trained?
Describe in short how and by whom the study data will be processed (data management)
Complete your Timeline (Gantt chart format) so that it contains the parts you have covered in your project plan. This should include FPI (First Patient In) as well as LPO (Last Patient Out) e.g..
The above requested information is not addressed in the course study synopsis, so it will be up to your team to decide how you will resolve it. Explain briefly why you have planned the study in the manner you have chosen and support it with references.