We started with the required minimum footprint. So, for example, we would take the protocol number that’s in the Coordinator Console in OnCore and we would say, based on our minimum footprint, we need to make sure this protocol number matches how we’re going to map to EPIC. So, when we would talk to people about the protocol number that we need to put into the CTMS, they knew we were talking about a field that interfaced to EPIC; not the sponsor protocol number, not an IRB number, etc. Having each of the fields identified with their ‘working definition,’ rather than a synonym, is how we went about it.
Anna: One thing that I’m currently doing is evaluating our Scientific Review Committee (SRC) submission forms. We are not utilizing ePRMS yet. Hopefully we will be by the end of the year, but currently we’re using a paper form submission process that’s very manual. A lot of the staff in the PRMS office are pretty new and most of the regulatory staff is pretty new, so there’s a lot of confusion back and forth as to what all of the fields mean and what the different requirements are. So, I created a database dictionary specifically for those forms that states:
- The question
- What the question means
- Why it’s being tracked
- The corresponding field in the CTMS that it will translate to
- Why it was previously asked and recorded
- The reports that it goes into