Hybrid data management can mean a few different things: It could mean that for all clinical sites, some data collection forms are completed electronically and some are completed on paper. Or, it could mean that some clinical sites do EDC only while some do paper only. Another possibility is that paper forms are available as a backup in case of power/internet outage, usually where the CDMS is the data source and the site doesn’t have anywhere else to record data if there’s no internet.
What other reasons are there for a hybrid approach?
If the trial includes multiple sites, it’s often best to work with the system that meets each site’s needs, whether that is paper or digital. That can vary for many reasons, including the country and the technical infrastructure.
Where sites want to continue capturing data on paper, a hybrid approach would be for a partner like DFnet to customize the paper for the site, scan it, and do the data entry for the site. This also saves monitors the trouble of going to the site to review the paper, because the paper has been scanned into the DFnet system.
Why would a sponsor or CRO choose a hybrid approach? Maybe the study has already started on paper or the sites are not comfortable with technology. Maybe the participants are not tech savvy. Often, patient-completed questionnaires or other non-CRF data (lab results, pathology results, etc.) must be submitted via paper, but the actual CRFs can be completed electronically.
Keep in mind, too, that EDC platforms vary and sites that have used one may be asked to use a different platform in future trials. In such cases, they may push back and insist on paper, because that they know how to do, that remains the same from trial to trial.
Finally, the hybrid approach is a great way for sponsors and sites to venture into the digital world without committing entirely.
Get the Support You Need to Transition with Ease.
Know that you don’t need to transition alone. There are expert resources available to help you. We at DFnet, for example, successfully transitioned from paper to EDC ourselves several years ago. With that experience behind us, and our track record of creating more than 2 million clinical records for studies conducted in 35 countries, we are the perfect partner for a team that is ready to move to or expand its use of digital technology in clinical research. Turn to us for help with common questions and concerns like these:
• Best practices for paper-based trials in a digital world
• Migrating from a paper-based form to an electronic consent process
• How to migrate from paper CRFs to electronic CRFs
• How to add eConsent and ePRO/eCOA to a traditional trial
• Best practices for managing global eConsent/reconsent for paper, digital, or hybrid trials
• Sensible approaches to compliant adoption of remote consenting and telemedicine
On these subjects and many more, we are ready to help.
To learn more about DFnet, and how we might help you with your clinical trials, reach out to us at firstname.lastname@example.org.