How Registry becomes Enroll-HD

The most complicated phase of Enroll-HD is just beginning. The European sites that are taking part in Registry began transitioning into Enroll-HD at the end of 2013, after more than a year of preparation. The first European participant to officially become part of Enroll-HD signed up in Ulm, Germany on December 6, 2013.

Transforming one study into another is tricky since everything has to be planned in advance. The goal is for nothing to be disrupted. Anyone who was part of Registry should be able to walk into the clinic, provide their HDID number (or the information that can recreate it) and pick up where they left off, without any break. But that requires careful coordination. “Finishing a study means you have to tidy up and make sure you cross your T’s and dot your I’s,” says Michael Orth, MD, PhD, the principal investigator at the site in Ulm. “It’s a lot of work to make sure the data you have in there is as good as it gets.”

The old database from Registry needs to synch up perfectly with the new “Electronic Data Capture” system (the computer system that holds and organizes Enroll-HD data, which is slightly different from the previous database). Even after all the technical work is completed to make that happen, the data doesn’t actually get moved into the new system until each participant officially agrees to become part of the new study. The data “is moved into a holding area,” explains Jenny Townhill, PhD, who oversees the finalization and transfer of the Registry database as migration manager for Enroll-HD. “The participant then has to show up at the Enroll-HD site and sign a new consent form. Otherwise, their old data never goes into the Enroll-HD database.” When the participant signs the new consent form, their data is now live, and is transferred electronically to a central database in the UK.

The transition began after more than a year of preparation

Registry, which began collecting data in 2004, included 17 nations and more than 12,000 participants at about 150 sites across Europe. Much like Enroll-HD, the study required yearly exams and cognitive tests to monitor any progression of the disease in participants. Enroll-HD uses similar methods, and relies on the same site staff. But because the data collection and storage technology for Enroll-HD is all new, and some of the tests that are part of the study are slightly different, merging the two studies is not simple.

Getting ready for the switch

Each study site must be switched over individually, because all the procedures to move the electronic data from one system to another must be done at the site itself, and there are a number of technical checks. But before that happens, all the paperwork for the study must be agreed upon and finalized, including approval from local or national ethics committees, official agreements between the site and the study organizers, and policies that maintain the privacy of participants. Enroll-HD also involves a few new tests, so the site staff who work with study participants learn how to give these new tests, and how to use the new Electronic Data Capture system.

Next comes the technical part of the transition: Making sure all of the data collected during the last decade in Registry is ready to flow smoothly into the new computer system. Each of the old database records must be ‘clean,’ with no blanks and no mistakes. The staff at Ulm began combing through their computer records in 2012 to correct oversights and errors by hand, says Katrin Barth, an information specialist who coordinated the transition team at the Ulm site. “It sounds easy, to move it from one database to the next,” she says. But making sure that every drug and every diagnosis has the right code number associated with it is time-consuming. “It’s a lot of work—you enter a term, the system comes up with several available codes, and you decide which ones are correct.” Computers can’t do this job, says Barth—only humans.

At the site in Ulm, the Registry database was officially frozen on November 25, 2013, meaning that no new information from study participants could be added to it. Specialists from 2MT, the small German software company that built the Enroll-HD Electronic Data Capture system, converted all the old data into the new format and spent two weeks testing it alongside the team at Ulm. Once they were sure there were no major problems the first participant was officially added to the Enroll-HD database.

Computers can’t do this job—only humans

So far, says Barth, everything has gone smoothly at Ulm. Following that success, the first UK site transitioned in mid-February in Manchester, and by early spring, three more in Germany and one more in the UK were expected to have switched over. Although the first transition went quickly, it’s not clear how long it will take for the rest of the sites to become part of Enroll-HD. “We’re feeling our way through for the first few transitions,” says Townhill. Sites in Germany, the UK, the Netherlands, Denmark, as well as Italy and Poland are expected to make the shift in 2014, around four per month. Townhill hopes that all the sites will be part of Enroll-HD by the end of 2015.