Do we need to submit screenshots of eCOA/ePRO diaries?

Question:

“If we are using an electronic tool for Clinical Outcome Assessment (eCOA), and the instrument was submitted for IRB review in document form before it was converted to electronic form, do we also need to submit screenshots of the electronic version?”

Response:

WCG IRB does not request screenshots of electronic COA instruments if either:

1. it is a standard, validated, commonly-used electronic questionnaire (e.g., SF-36) or
2. if the content was submitted in its non-electronic form (e.g., as a word document), the WCG IRB has approved the content and nothing is being changed in the electronic version except the presentation/ display.

While ICH GCP requires that the IRB review all participant-facing materials, the primary concern of the IRB is to review the content of any evaluation instruments and questionnaires to make sure there is nothing promotional or unduly influential about the study or the study intervention, and that any risks that may be associated with the instruments are recognized and minimized (e.g., if there are questions that could trigger or reveal suicidal ideation in a study of severe depression). It would be very rare for reformatting from document to electronic form to change these risks or the risk consideration, therefore requiring screenshots when the content has already been reviewed and approved does not add any real benefit.