Evidence map›Paper›PMID 41052664›Full record

ArticleJournal of biomedical informatics2025

A REDCap advanced randomization module to meet the needs of modern trials.

Luke Stevens, Nan Kennedy, Rob J Taylor, Adam Lewis, Frank E Harrell, Matthew S Shotwell, Emily S Serdoz, Gordon R Bernard, Wesley H Self, Christopher J Lindsell and 2 more

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Journal of biomedical informatics, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

  1. Trial
  2. Article
  3. Article
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  5. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors.

Luke StevensMurdoch Children's Research Institute, The Royal Children's Hospital, Parkville, Victoria, Australia; Clinical Epidemiology and Biostatistics Unit, Department of Paediatrics, The University of Melbourne, Parkville, Victoria, Australia.
Nan KennedyVanderbilt Institute for Clinical and Translational Research, Vanderbilt University Medical Center, 2525 West End Ave, Nashville, TN, USA.
Rob J TaylorVanderbilt Institute for Clinical and Translational Research, Vanderbilt University Medical Center, 2525 West End Ave, Nashville, TN, USA.
Adam LewisVanderbilt Institute for Clinical and Translational Research, Vanderbilt University Medical Center, 2525 West End Ave, Nashville, TN, USA.
Frank E HarrellDepartment of Biostatistics, Vanderbilt University Medical Center, Nashville, TN, USA.
Matthew S ShotwellVanderbilt Institute for Clinical and Translational Research, Vanderbilt University Medical Center, 2525 West End Ave, Nashville, TN, USA; Department of Biostatistics, Vanderbilt University Medical Center, Nashville, TN, USA.
Emily S SerdozVanderbilt Institute for Clinical and Translational Research, Vanderbilt University Medical Center, 2525 West End Ave, Nashville, TN, USA.
Gordon R BernardVanderbilt Institute for Clinical and Translational Research, Vanderbilt University Medical Center, 2525 West End Ave, Nashville, TN, USA; Department of Medicine, Vanderbilt University Medical Center, Nashville, USA.
Wesley H SelfVanderbilt Institute for Clinical and Translational Research, Vanderbilt University Medical Center, 2525 West End Ave, Nashville, TN, USA; Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.
Christopher J LindsellDepartment of Biostatistics and Bioinformatics and Department of Biomedical Engineering, Duke University, and Duke Clinical Research Institute, Durham, NC, USA.
Paul A HarrisVanderbilt Institute for Clinical and Translational Research, Vanderbilt University Medical Center, 2525 West End Ave, Nashville, TN, USA; Department of Biomedical Informatics, Vanderbilt University Medical Center, Nashville, TN, USA.
Jonathan D CaseyVanderbilt Institute for Clinical and Translational Research, Vanderbilt University Medical Center, 2525 West End Ave, Nashville, TN, USA; Division of Allergy, Pulmonary, and Critical Care Medicine, Department of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA. Electronic address: jonathan.d.casey@vumc.org.

Funding

Engaging Cooperative Sites for Trial Acceleration, Trust, Innovation, and Capability (ECSTATIC)U24TR004437 · VANDERBILT UNIVERSITY MEDICAL CENTER · 2025 to 2025
$4.8M
NCATS NIH HHS U24 TR004437
6 · The paper itself

Abstract

objectiveSince 2012, the electronic data capture platform REDCap has included an embedded randomization module allowing a single randomization per study record with the ability to stratify by variables such as study site and participant sex at birth. In recent years, platform, adaptive, decentralized, and pragmatic trials have gained popularity. These trial designs often require approaches to randomization not supported by the original REDCap randomization module, including randomizing patients into multiple domains or at multiple points in time, changing allocation tables to add or drop study groups, or adaptively changing allocation ratios based on data from previously enrolled participants. Our team aimed to develop new randomization functions to address these issues.

methodsA collaborative process facilitated by the NIH-funded Trial Innovation Network was initiated to modernize the randomization module in REDCap, incorporating feedback from clinical trialists, biostatisticians, technologists, and other experts.

resultsThis effort led to the development of an advanced randomization module within the REDCap platform. In addition to supporting platform, adaptive, decentralized, and pragmatic trials, the new module introduces several new features, such as improved support for blinded randomization, additional randomization metadata capture (e.g., user identity and timestamp), additional tools allowing REDCap administrators to support investigators using the randomization module, and the ability for clinicians participating in pragmatic or decentralized trials to perform randomization through a survey without needing log-in access to the study database. As of June 19, 2025, multiple randomizations have been used in 211 projects from 55 institutions, randomizations with real-time trigger logic in 108 projects from 64 institutions, and blinded group allocation in 24 projects from 17 institutions.

conclusionThe new randomization module aims to streamline the randomization process, improve trial efficiency, and ensure robust data integrity, thereby supporting the conduct of more sophisticated and adaptive clinical trials.

Indexed as

Randomized Controlled Trials as TopicElectronic Health RecordsHumansRandom AllocationResearch DesignUnited StatesAdaptive trialsDecentralized trialsMulti-stage randomizationPlatform trialsRandomization moduleREDCapSMART trials

Identifiers

PMID41052664
PMCPMC12977000

What Socratic holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.