Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2022 Mar:114:106660.
doi: 10.1016/j.cct.2021.106660. Epub 2022 Jan 25.

Technical procedures and REDCap tools for internet-based clinical trials

Affiliations

Technical procedures and REDCap tools for internet-based clinical trials

Ananta S Bangdiwala et al. Contemp Clin Trials. 2022 Mar.

Abstract

In March of 2020 our team of researchers developed and opened three clinical trials to investigate hydroxychloroquine as prophylaxis or treatment for the coronavirus disease 2019 (COVID-19). We simultaneously built corresponding Research Electronic Data Capture (REDCap) projects for these low-touch, remote trials that relied on participant-reported data. REDCap has built-in features that support pragmatic, internet-based studies, and REDCap is flexible enough to allow creative solutions for specific trials. We describe challenges, choices, and suggestions based on our experience with REDCap for our COVID-19 trials.

Keywords: Automation; Clinical trials; Covid-19; Data base management; Patient-oriented research; Survey.

PubMed Disclaimer

Conflict of interest statement

The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Figures

Fig. 1
Fig. 1
Branched logic example screening->enrollment (PEP/Treatment)

References

    1. Pastick K.A., Okafor E.C., Wang F., Lofgren S.M., Skipper C.P., Nicol M.R., Pullen M.F., Rajasingham R., McDonald E.G., Lee T.C., Schwartz I.S., Kelly L.E., Lother S.A., Mitja O., Letang E., Abassi M., Boulware D.R. Review: Hydroxychloroquine and chloroquine for treatment of SARS-CoV-2 (COVID-19) Open Forum Infect Dis. 2020;7 doi: 10.1093/ofid/ofaa130. ofaa130. PMCID: 7184359. - DOI - PMC - PubMed
    1. Boulware D.R., Pullen M.F., Bangdiwala A.S., Pastick K.A., Lofgren S.M., Okafor E.C., Skipper C.P., Nascene A.A., Nicol M.R., Abassi M., Engen N.W., Cheng M.P., LaBar D., Lother S.A., MacKenzie L.J., Drobot G., Marten N., Zarychanski R., Kelly L.E., Schwartz I.S., McDonald E.G., Rajasingham R., Lee T.C., Hullsiek K.H. A randomized trial of hydroxychloroquine as postexposure prophylaxis for covid-19. N. Engl. J. Med. 2020;383:517–525. doi: 10.1056/NEJMoa2016638. PMCID: 7289276. - DOI - PMC - PubMed
    1. Skipper C.P., Pastick K.A., Engen N.W., Bangdiwala A.S., Abassi M., Lofgren S.M., Williams D.A., Okafor E.C., Pullen M.F., Nicol M.R., Nascene A.A., Hullsiek K.H., Cheng M.P., Luke D., Lother S.A., MacKenzie L.J., Drobot G., Kelly L.E., Schwartz I.S., Zarychanski R., McDonald E.G., Lee T.C., Rajasingham R., Boulware D.R. Hydroxychloroquine in nonhospitalized adults with early COVID-19 : A randomized trial. Ann. Intern. Med. 2020;173:623–631. doi: 10.7326/M20-4207. PMCID: 7384270. - DOI - PMC - PubMed
    1. Rajasingham R., Bangdiwala A.S., Nicol M.R., Skipper C.P., Pastick K.A., Axelrod M.L., Pullen M.F., Nascene A.A., Williams D.A., Engen N.W., Okafor E.C., Rini B.I., Mayer I.A., McDonald E.G., Lee T.C., Li P., MacKenzie L.J., Balko J.M., Dunlop S.J., Hullsiek K.H., Boulware D.R., Lofgren S.M. Hydroxychloroquine as pre-exposure prophylaxis for coronavirus disease 2019 (COVID-19) in healthcare workers: A randomized trial. Clin. Infect. Dis. 2021;72 doi: 10.1093/cid/ciaa1571. e835-e43. PMCID: 7665393. - DOI - PMC - PubMed
    1. Harris P.A., Taylor R., Minor B.L., Elliott V., Fernandez M., O’Neal L., McLeod L., Delacqua G., Delacqua F., Kirby J., Duda S.N. The redcap consortium: Building an international community of software platform partners. J. Biomed. Inform. 2019;95:103208. doi: 10.1016/j.jbi.2019.103208. PMCID: 7254481. - DOI - PMC - PubMed

Publication types

Substances

LinkOut - more resources