Evidence map›Paper›PMID 41743929›Full record

ArticleJournal of clinical and translational science2026

Collaborative compliance: A consortium-based framework for achieving 21 CFR part 11 readiness in REDCap across CTSA institutions.

Theresa Baker, Teresa Bosler, April Green, Jason Lones, Katie Keenoy, Bridget Adams, Bas de Veer, Brian Bush, Stephanie Oppenheimer, Sheree Hemphill and 9 more

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Journal of clinical and translational science, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing 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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

19 authors.

Theresa BakerVanderbilt University Medical Center, USA.ORCID https://orcid.org/0000-0002-2068-5989
Teresa BoslerVanderbilt University Medical Center, USA.
April GreenThe Ohio State University, USA.
Jason LonesThe Ohio State University, USA.
Katie KeenoyWashington University in St Louis School of Medicine, USA.ORCID https://orcid.org/0000-0001-7207-5974
Bridget AdamsOregon Health & Science University, USA.
Bas de VeerWake Forest School of Medicine, USA.
Brian BushVirginia Commonwealth University, USA.
Stephanie OppenheimerMedical University of South Carolina, USA.
Sheree HemphillCase Western Reserve University, USA.
Elinora PriceYale University, USA.
Haley NeeseDuke University, USA.
Ashley TippettEmory University, USA.
Audrey PerdewCincinnati Children's Hospital Medical Center, USA.
Randy MadsenUniversity of Utah, USA.
Catherine Bauer-MartinezIcahn School of Medicine at Mount Sinai, USA.
Robert BradfordUniversity of North Carolina at Chapel Hill, USA.
Paul HarrisVanderbilt University Medical Center, USA.ORCID https://orcid.org/0000-0002-1744-2011
Alex ChengVanderbilt University Medical Center, USA.ORCID https://orcid.org/0000-0002-1787-691X

Funding

Oregon Clinical and Translational Research Institute - The National COVID Cohort Collaborative (N3C)UL1TR002369 · NCATS · OREGON HEALTH & SCIENCE UNIVERSITY · PI Cynthia D Morris, Christopher G. Slatore · 2017 to 2026
$78.4M
NCATS NIH HHS UL1 TR002369
6 · The paper itself

Abstract

Academic research institutions using REDCap often face challenges aligning with U.S. FDA requirements for electronic records and signatures under 21 CFR Part 11 (Part 11). A National Center for Advancing Translational Sciences(NCATS) working group developed an implementation guide for Part 11 compliance in REDCap. Within six months after release, 259 individuals representing 164 institutions accessed the guide. Individuals who downloaded the guide reported reduced vendor reliance, improved documentation, and establishment Part 11-ready REDCap instances. This working group demonstrated how collaboration between technical and regulatory experts at many peer institutions is effective in improving regulatory compliance across the research enterprise.

Indexed as

Complianceelectronic data captureimplementationsoftwareworking groups

Identifiers

PMID41743929
PMCPMC12930199

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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 OpenQuestion graph.