List of questions on patient participation in the Standard Research File

Were patients engaged during the development of this study? (For patients you can also read: patient organisations, next of kin and other relatives and healthy volunteers)

yes
no, justify why no patients were engaged in the study.

In which parts of the study were, or will be, patients engaged? (For patients you can also read: patient organisations, next of kin and other relatives and healthy volunteers). Multiple answers are possible.

brainstorming on the research question
brainstorming on relevant study outcomes
designing the research protocol
estimating whether patient burden is realistic
developing patient information materials (SIS/ICF)
recruitment strategy
disseminating findings
lay summary of study results
otherwise, namely:

What were the insights/choices that resulted from the input, as specified above?

Who have been engaged?

healthy volunteers
patient organisations
patient representatives
individual patients
next of kin or other relatives
otherwise, namely:

Will patients (other than as study participant) stay actively engaged during the study?

yes
no

Does the study have budget for patient engagement (other than the reimbursement for study participants)?

yes
no

Will the experience of study participants be evaluated after their participation?

yes
no