Our project is composed mostly of retrospective data and some prospective data. We are not planning on consenting participants since we will be analyzing publicly available data, aggregate data and doing chart reviews. Do we need to integrate the minimum CDE survey questions to our project?
What we are recommending is to collect data according to the CDEs and not in a different format. Prospective data are those data that come into existence after your study begins and may require informed consent or a waiver of consent by the IRB. Consult with your IRB as needed.