Biostatistics and Health Science and IU REDCap - Steven Brown and Netsanet Gebregziabher

Filmed during IU REDCap Day 2023 - go.iu.edu/iu-r...
The Department of Biostatistics and Health Data Science (BHDS) was one of the first users of REDCap at Indiana University and we find it to be an advantageous tool for research data collection. BHDS is involved in the study conduct of research with internal and external collaborators. Some of our studies utilized MS Excel for data collection while others used outside platforms that were costly to implement and maintain. REDCap gave the option of integrating all types of studies into one system that is cost-effective, easy to train users, and maintain information gathered whether via surveys or data entry forms.
BHDS has had opportunities to collaborate with single and multi-site research projects that are in the arenas of clinical, behavioral, observational, and genomic. It is important that we have a system that allows the collection of various types of measurements and is flexible for writing, testing, and implementing rules that would abide by Good Data Management Practices to ensure quality and protected data for statistical analysis. REDCap’s functionalities and features have addressed this with: Project Design and Set-up, Randomization, Data Resolution Workflow, surveys, and various options of communicating with participates and data entry to complete the entry forms to name a few.
The Project Design and Set-up has been helpful in controlling user roles along with measurement access at form and overall level. Randomization feature is also one that is helpful for multiple studies. There may be occasions where studies have randomization and certain users are unblinded while others are to remind blinded. BHDS has found that REDCap’s simple tool of Data Access groups along with at the user role level controlling what forms a user can see or not controls the protocol requirements on blinding. Another tool that is instrumental in helping the sites and the study maintain consistent awareness of changes to the data and making sure it is accounted for is the Data Resolution Workflow. It allows for auditing to ask data entry on quality control issues on different measurements/instruments.
BHDS has used REDCap for studies under the umbrella of Clinical Trials Office (CTO) or dealt directly with the Principal Investigator with an Investigator Initiated Trial (IIT). Some studies may be federally regulated (i.e., Investigational New Drug (IND) Application) and we play a part along with REDCap concerning compliance of federal requirements. For the latter we typically have paper source and then have the sites re-enter the information from paper to REDCap database. This is because IU’s REDCap instance doesn’t currently meet 21 Code of Federal Regulation (CFR) Part 11.
BHDS has utilized REDCap for studies conducting data collection by contacting participants via phone text (SMS text) and filling out surveys. This was done via the integration of Twilio Integration + REDCap. BHDS has also used REDCap’s API function to pull in information and do queries along with multiple other outputs for both internal and external collaborations.
The REDCap functionalities have been a wonderful resource for those studies that require special filters or equations to move to the next phase of study requirement between or within instruments. For example, there may be a validated instrument on anxiety or sleep that a participant must have a certain score, or certain number of questions answered to move on to randomization. REDCap’s functionality options allow for different manipulation of the forms to garner the results needed for the project to be successful.
Overall, the great options that REDCap offers our research projects has made it one of the top options for choosing a system to collect and store research data. We are glad to collaborate and to work with the great IU REDCap Administrators who have been a wonderful resource in showcasing and troubleshooting questions that make it easier to continue to use and grow with new functionalities that this system offer.
To view a PDF of the slides, to learn more about the presenter(s), or to see more presentations from IU REDCap Day 2023 visit: iuredcapday202...
IU REDCap Day was hosted by Research Technologies (RT). RT is a division of University Information Technology Services and a center in the Pervasive Technology Institute at Indiana University.
rt.iu.edu
pti.iu.edu
Filmed May 18, 2023