Screen Reports have been bugging us for years. Allegedly all patient-facing materials need to be approved by the IRB/EC prior to the start of participant enrolment.
Producing these screen reports for the submission to regulators and to IRB/ECs is often requested prior to the finalization of technical solution. It certainly puts a strain on resources within the eCOA partners.
A small team ventured into the realm of this requirement of “all patient-facing material” needs to be presented to IRB/ECs and found………no evidence that this is actually a legal requirement. (see reference below)
Independent IRBs (Advarra and WCG) have gone on record recently stating that they do NOT require screenshots with their submission.
Having spoken with both organizations it becomes clear that reviewing validated questionnaires does not improve patient safety at all. How many times do IRB/ECs want to look at an EQ-5D-5L or an SF-36?
In our industry nothing moves fast and so it is no surprise that we see only small wins. Often CROs and conservative sponsors are still insisting on providing eCOA screen reports for submissions.
We are convinced that IRB/ECs have better things to do than to review these questionnaires and we encourage everyone to challenge your CRO, IRB, EC and colleagues to improve one aspect of eCOA.
