I consider myself as pretty technology-savvy, and barcode scanners really shouldn't be a problem for me. However, this morning I was cursing the grocery store that had these self-service checkouts installed.
I usually do my weekly grocery shopping at Waitrose which has handheld barcode scanners, so shoppers would scan the items and put them into shopping bags as they go round the supermarket. At the end of shopping, just scan the "finish shopping" barcode at the checkout machine and pay. Quick and simple - no need for taking all the shopping items off the trolley and repacking at the other end of the conveyor belt. When I first joined this scheme, I had a quick 2-minute training by the staff, and everything on the scanner was intuitive. When I have a problem with scanning any items, I just go to the checkout and always get this sorted quickly by the staff. It almost makes the chore of weekly food shopping fun!
This morning I went to another supermarket just to pick up a few items. This shop installed the self-service checkouts. The process has not fundamentally changed from the manned checkouts - you go round the supermarket, put the items in the trolley, then take them out of the trolley at checkout, and then put them in bags.
So what has this got to do with EDC (Electronic Data Capture), I hear you ask! With the changes in the way clinical trials and data management are performed, EDC is becoming more and more commonplace. Many people naively think that once the technology is in place, the benefits can be seen immediately without examining (and possibly changing) the process and also putting in place the right support. I am going to draw some parallels to my grocery shopping experience:
(1) Process: The idea of self-service scanning (whether using a handheld scanner or at checkout) is to reduce the long queues often found at checkouts. Most supermarkets have opted for self-service checkouts but the fundamental process of shopping has not changed. Waitrose, on the other hand, must have stood back and looked at the whole process, and has opted for a change in the way people would shop. From what I have seen, Waitrose seems to have managed to cut the queues dramatically because customers can put their shopping into the bags as they go along, and once they have finished, they just pay and go. In the drug development world, you cannot simply introduce an EDC system based on a paper-based CRF process, and you need to stand back and look at how the technology may affect various parts of the business, not just data management. I have seen a company suggesting to me that they needed to print out the eCRF at the end of the study and do a QC against what's on screen - when I asked why, they said that it was their normal process in a paper-based study and they just carried on with EDC studies!
(2) Training & User-friendly device: I was given a very short but helpful training on the handheld scanner the very first time I used it, and by the end of the first shopping adventure using this device, I was already pretty proficient with it. The scanner is simple - only a few functions and any messages on screen are pretty self-explanatory. Can't scan the item? No worry - just take it to the customer service at the end of the shopping and they will sort it out. With the self-service checkouts,when the barcode scanner going blind and doesn't recognise the item (so you can't proceed any further until an assistant comes and helps you, which usually means a 5-minute). or when the phrase "unexpected item in the bagging area" pops up on screen (or worse when the machine announces that loudly), you can't figure out what was the unexpected item. In the EDC world, if I were an investigator, I would find it frustrating if I got bombarded with complex messages in a system that has a steep learning curve. With data getting more complicated, we have a tendency to design CRFs that are too complex - ask yourself this question: Do you really need to collect all these data (or are they "nice-to-have" or "just-in-case-we-need-it")?
(3) Workflow: There was one time when I was expecting a mixture of notes and loose change for my shopping, and I spent a good minute looking for my £5 note close to where the machine spit out the coins, before realising that the note was in an obscure place on the other side of the machine! With EDC, the navigation of the eCRF needs to be clear and intuitive, and user testing would help.
(4) Support: With the self-service checkouts, it seems that there's usually one assistant assigned to every 6 checkout machines. As many customers seem to have one problem or another with the scanning, the poor assistant is always rushing around trying to firefight. To date I have only managed to complete the whole scanning and paying process without the intervention of the assistant once! The record waiting time for an assistant to help was 5 minutes - I nearly gave up and walked out of the shop. Similarly with EDC, user support is important.
Although I have been comparing my grocery shopping with EDC here, the same lessons can be applied to other technologies, whether it's in clinical trial or in other business areas or industries.