Technical procedures and REDCap tools for internet-based clinical trials
- PMID: 35085832
- PMCID: PMC8786406
- DOI: 10.1016/j.cct.2021.106660
Technical procedures and REDCap tools for internet-based clinical trials
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.
Copyright © 2022 Elsevier Inc. All rights reserved.
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
References
-
- 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
-
- 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
-
- 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
-
- 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
-
- 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
MeSH terms
Substances
LinkOut - more resources
Full Text Sources