What are your predictions for the future of data management?

“Data management will become more and more focused on integrating data from many, disparate sources, and applying the same standards of scrutiny and quality to each of those sources. Currently, each data source has a unique set of processes associated with it. In the future, the data manager will not know the source of data—and will not care about the source.”

— Eric Bosch, Director of Software Development at DFnet

“There will be more integration between various systems—healthcare systems, imaging systems, patient wearables, patient-reported data. More systems will be talking to each other, but there will be strict controls around who gets to see what. The barriers to this are concerns about privacy, security, data standards, and system design, but the upside is the potential for access to more data with less human intervention.”

— Laura Joldersma, Clinical Data Management Specialist at DFnet

How can you tell that it’s time for a research team to move from paper source data to digital?

“Researchers who are asking questions about their internal processes and wondering if their existing processes have given them the most efficient and effective results are ready to move forward.”

— Eric Bosch, Director of Software Development at DFnet

“Clinical sites that are ready to modernize recognize that paper is not sustainable and show a willingness to secure the necessary training, IT support, and internet access required to move from paper to EDC.”

— Laura Joldersma, Clinical Data Management Specialist at DFnet

What strategies have you used to help move client research teams from paper source data to digital?

“Providing plenty of training and reliable support. Careful CRF and EDC design to make the process as easy as possible for sites and not overburden them with data queries is helpful. Teams should keep in mind, too, that EDC uptake works better when staff are using the system regularly, as opposed to infrequently. When sites don’t recruit many patients and/or patient visits are infrequent, the team can forget how to use the EDC system.”

— Laura Joldersma, Clinical Data Management Specialist at DFnet

“Sometimes it’s a slow process. You might start with just a few electronic CRFs—as for electronic randomization, for example—with the rest on paper. If the sites are collecting source data on paper, they should know that they could put a barcode on it and scan it to a partner like DFnet. They don’t need to use paper source and then type it into EDC. It can help to use CRF backgrounds that resemble paper in the database for data entry to make it feel more familiar for the site. On the other hand, sometimes it’s best to just rip off the Band-Aid.”

— Lisa Ondrejcek, President and Co-owner at DFnet

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Is it always best to use digital processes rather than paper?

“It depends on the clinical site’s preference, experience, and capabilities. What kind of data is being collected and how, as required by the study protocol, also makes a difference. What is the study workload on the sites and would it be useful to mitigate that by reducing the burden of data entry? Also, is there sponsor support for EDC vs. paper? That is important.”

— Laura Joldersma, Clinical Data Management Specialist at DFnet

“In general, I think EDC is always the best approach if the site has the capabilities.”

— Karolyn Scott, Clinical Data Manager at DFnet

“Has the data already been collected? Are sites able to use technology effectively? Are there other checks in the data to ensure that the electronic data is consistent? What is the feedback from the study participants and/or data collection staff? Is there a requirement to collect all of the paper centrally? These are critical questions.”

—Eric Bosch, Director of Software Development at DFnet

“Technical infrastructure must be adequate. Sometimes a site will say they have good internet when it’s actually quite spotty. That won’t work. Similarly, things don’t go well when the sponsor has strong desires that run counter to site realities.”

— Lisa Ondrejcek, President and Co-owner at DFnet

Is a hybrid paper-digital approach valid?

“In many cases it is. For example, patient-completed questionnaires or other non-CRF data such as lab reports or pathology results must be submitted via paper but the actual CRFs could be completed electronically.”

— Karolyn Scott, Clinical Data Manager at DFnet

“Some clinical sites aren’t really equipped to do EDC. Others just haven’t done it yet and are scared or unwilling to change. Still, if they are great recruiters and have a good research track record, the sponsor may want them to participate anyway. Also, for some types of research, it’s not practical to enter data directly into an electronic system. It’s more in line with usual clinical procedures to record data on well-designed paper forms. Instead of requiring the sites to then transcribe the data into an EDC system, the sites can submit a copy of the paper form and the data is entered by trained data management staff.”

— Laura Joldersma, Clinical Data Management Specialist at DFnet

“A hybrid approach makes sense if the study has already started on paper or if the sites are not comfortable with technology. And if the infrastructure to support technology is not great there will need to be some reliance on paper.”

—Eric Bosch, Director of Software Development at DFnet

“When there are multiple sites, it’s best to work with the systems that meet the sites’ needs. Some sites may prefer paper as source, and then instead of using their time to enter the data, they scan that to us at DFnet. It’s important to consider the site, the country, and the technical infrastructure in place.”

— Lisa Ondrejcek, President and Co-owner at DFnet

Where are you on the paper-to-digital continuum and how can we help?

The fact is that most trials still rely on some form of paper source data or include sites with limited connectivity. At DFnet, we understand and are fully committed to supporting clients wherever they are in the transition to digital and whatever challenges their trial involves.

To learn more about DFnet, and how we might help you with your clinical trials, reach out to us at info@dfnetresearch.com.