Correction of ePRO data
Should patients be able to change their submitted data? And if so, who is allowed to make changes, when can changes be made, and how will it affect the balance between data authenticity and data quality?
Regulatory authorities recently issued a critical finding to a commercial ePRO vendor due to processes related to data integrity of ePRO data. One of the identified issues was that incorrect data submitted into the ePRO system could not be changed and were subsequently included in the study results. Requests to change the incorrect data had been submitted by the investigators but were rejected as it was explained that changes to the data could not be made.
In a new white paper, we discuss these issues in order to start reevaluating the traditional view that ePRO data should not be changed, and present the way we have chosen to address the possibility to correct ePRO data when using Viedoc.