Explanipedia

Concordance of Death Information of Two Health Systems Serving the Same Region and Social Security Administration Death Master File in the Southern United States (Preprint) Open

Z. Wang, Mahanaz Syd, Shweta Bansal, Meredith Zozus, Eric L. Eisenstein , et al. · 2025

BACKGROUND There are multiple sources that document the date of a person’s death in the United States. Unfortunately, this seemingly simple information is either incomplete or costly to obtain. On the other hand, the information of such e…

Evaluating the Impact of Electronic Health Record to Electronic Data Capture Technology on Workflow Efficiency: a Site Perspective Open

Anna Patruno, Michael-Owen Panzarella, Michael Buckley, Milena Silverman, Eduardo Salazar , et al. · 2025

Introduction Clinical trial data is still predominantly manually entered by site staff into Electronic Data Capture (EDC) systems. This process of abstracting and manually transcribing patient data is time-consuming, inefficient and error …

Measuring alignment between the ADRC UDS data elements, FDA, and EHR data standards Open

Z. Wang, Kayla Torres, Helen Foster, Gary Walker, Maryam Y. Garza , et al. · 2025

INTRODUCTION We compared and measured alignment between the Health Level Seven (HL7) Fast Healthcare Interoperability Resources (FHIR) standard used by electronic health records (EHRs), the Clinical Data Interchange Standards Consortium (C…

Comparing the Accuracy of Traditional vs. Electronic Health Record Extracted Data in a Clinical Trial Open

Maryam Y. Garza, Muayad Hamidi, Iddo Peleg, Sapir Balas, Byeong Yeob Choi , et al. · 2025

As pressure to increase operational efficiency in clinical trials grows, organizations are looking to advances such as tools enabling extraction of Electronic Health Record (EHR) data and transmission to the study database or electronic Ca…

Measuring Expressiveness of the Clincal Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM) for the American Burn Association Burn Care Quality Program Registry Real-World Data (RWD) Open

Manju Bikkanuri, Muayad Hamidi, Meredith Zozus, Maryam Y. Garza · 2025

The United States (US) 21st Century Cures Act of 2016 was developed to accelerate development of new therapeutics. The use of real-world data (RWD) in regulatory submissions for therapeutic development in the US is increasingly supported b…

562 Mapping and navigating translational resources with generative AI Open

Jonathan Gelfond, Meredith Zozus, Martin Goros, Jennifer Sharpe Potter, K. Summers , et al. · 2025

Objectives/Goals: Translational researchers often struggle to navigate a complex constellation of institutional resources spanning the IRB to bioinformatics units. We had two aims 1) Systematically map all institution-wide research support…

Comparing Medical Record Abstraction (MRA) error rates in an observational study to pooled rates identified in the data quality literature Open

Maryam Y. Garza, Tremaine B. Williams, Songthip Ounpraseuth, Zhuopei Hu, Jeannette Y. Lee , et al. · 2024

Comparing the Accuracy of Traditional vs. FHIR®-Based Extraction of Electronic Health Record Data for Two Clinical Trials Open

Maryam Y. Garza, Christina Spencer, Muayad Hamidi, Michael A. Liss, Manju Bikkanuri , et al. · 2024

While pilots and production use of software based on the Health Level Seven (HL7®) Fast Healthcare Interoperability Resources (FHIR®) standard are increasing in clinical research, we lack consistent evaluative data on important outcomes, s…

Clinical Data Warehousing: A Scoping Review Open

Z. Wang, Catherine K. Craven, Mahanaz Syed, Melody Greer, Emel Seker , et al. · 2024

INTRODUCTION: A clinical data warehouse (CDW) is a powerfulresource that supports clinical decision-making and secondary data use byintegrating and presenting heterogeneous data sources. Despite considerableeffort within healthcare organiz…

Toward standardization, harmonization, and integration of social determinants of health data: A Texas Clinical and Translational Science Award institutions collaboration Open

Catherine K. Craven, Linda Highfield, Mujeeb Basit, Elmer V. Bernstam, Byeong Yeob Choi , et al. · 2024

Introduction: The focus on social determinants of health (SDOH) and their impact on health outcomes is evident in U.S. federal actions by Centers for Medicare & Medicaid Services and Office of National Coordinator for Health Information Te…

Source Data Verification (SDV) quality in clinical research: A scoping review Open

Muayad Hamidi, Eric L. Eisenstein, Maryam Y. Garza, Kayla Joan Torres Morales, Erika M. Edwards , et al. · 2024

Introduction: The value of Source Data Verification (SDV) has been a common theme in the applied Clinical Translational Science literature. Yet, few published assessments of SDV quality exist even though they are needed to design risk-base…

Toward standardization, harmonization, and integration of social determinants of health data: A Texas Clinical and Translational Science Award institutions collaboration – CORRIGENDUM Open

Catherine K. Craven, Linda Highfield, Mujeeb Basit, Elmer V. Bernstam, Byeong Yeob Choi , et al. · 2024

[This corrects the article DOI: 10.1017/cts.2024.2.].

Error Rates of Data Processing Methods in Clinical Research: A Systematic Review and Meta-Analysis of Manuscripts Identified Through PubMed Open

Maryam Y. Garza, Tremaine B. Williams, Songthip Ounpraseuth, Zhuopei Hu, Jeannette Y. Lee , et al. · 2023

Background: In clinical research, prevention of systematic and random errors of data collected is paramount to ensuring reproducibility of trial results and the safety and efficacy of the resulting interventions. Over the last 40 y…

Comparing Medical Record Abstraction (MRA) Error Rates in an Observational Study to Pooled Rates Identified in the Data Quality Literature Open

Maryam Y. Garza, Tremaine B. Williams, Songthip Ounpraseuth, Zhuopei Hu, Jeannette Y. Lee , et al. · 2023

Assessing clinical site readiness for electronic health record (EHR)-to-electronic data capture (EDC) automated data collection Open

Eric L. Eisenstein, Meredith Zozus, Maryam Y. Garza, Holly J. Lanham, Bhargav Adagarla , et al. · 2023

Informatics infrastructure in a rural pediatric clinical trials network: Matching specific clinical research needs with best practices and industry guidelines Open

Melody Greer, Maryam Y. Garza, Jeannette Y. Lee, Fred Prior, Lawrence Tarbox , et al. · 2023

Error Rates of Data Processing Methods in Clinical Research: A Systematic Review and Meta-Analysis Open

Maryam Y. Garza, Tremaine B. Williams, Songthip Ounpraseuth, Zhuopei Hu, Jeannette Lee , et al. · 2023

Background: Over the last 30 years, empirical assessments of data accuracy in clinical research have been reported in the literature. Although there have been articles summarizing results reported in multiple papers, there has been little …

Electronic health record data quality variability across a multistate clinical research network Open

Yahia Mohamed, Xing Song, Tamara M. McMahon, Suman Sahil, Meredith Zozus , et al. · 2023

Background: Electronic health record (EHR) data have many quality problems that may affect the outcome of research results and decision support systems. Many methods have been used to evaluate EHR data quality. However, there has yet to be…

Collaborative Program to Evaluate Real World Data for Use in Clinical Studies and Regulatory Decision Making. Open

Meredith Zozus, Byeong Yeob Choi, Maryam Y. Garza, Rhonda Facile, Holly J. Lanham , et al. · 2023

The 21^st Century Cures Act allows the US Food and Drug Administration to consider real world data (RWD) for new indications or post approval study requirements. However, there is limited guidance as to the relative quality of di…

Economic analysis of a single institutional review board data exchange standard in multisite clinical studies Open

Eric L. Eisenstein, Anita Walden, Katrina Donovan, Meredith Zozus, Feliciano Yu , et al. · 2022

Measuring and controlling medical record abstraction (MRA) error rates in an observational study Open

Maryam Y. Garza, Tremaine B. Williams, Sahiti Myneni, Susan H. Fenton, Songthip Ounpraseuth , et al. · 2022

474 Innovative solutions to streamline data collection, exchange, and utilization in translational research Open

Maryam Y. Garza, Fred Prior, Joseph A. Sanford, Kevin W. Sexton, Meredith Zozus · 2022

OBJECTIVES/GOALS: To determine the utility of any standard, one must first evaluate whether or not the standard meets the needs of the use case it is meant to support. We aim to quantify data availability of the HL7 FHIR standard to suppor…

Measuring and Controlling Medical Record Abstraction (MRA) Error Rates in an Observational Study Open

Maryam Y. Garza, Songthip Ounpraseuth, Zhuopei Hu, Jeannette Y. Lee, Jessica Snowden , et al. · 2022

Background: Studies have shown that data collection by medical record abstraction (MRA) is a significant source of error in clinical studies. Yet, the quality of data collected using MRA is seldom assessed. We employed a novel, theory-base…

Informing training needs for the revised certified clinical data manager (CCDMTM) exam: analysis of results from the previous exam Open

Tremaine B. Williams, Carsten Schmidtke, Kevin M. Roessger, Vicki Dieffenderfer, Maryam Y. Garza , et al. · 2022

Objective To inform training needs for the revised Certified Clinical Data Manager (CCDMTM) Exam. Introduction Clinical data managers hold the responsibility for processing the data on which research conclusions and regulatory decisions ar…

Informatics Infrastructure in a Rural Pediatric Clinical Trials Network: Matching Specific Clinical Research Needs with Best Practices and Industry Guidelines Open

Melody Greer, Maryam Y. Garza, Jeannette Lee, Fred Prior, Lawrence Tarbox , et al. · 2022

DeIDNER Model: A Neural Network Named Entity Recognition Model for Use in the De-identification of Clinical Notes Open

Mahanazuddin Syed, Kevin W. Sexton, Melody Greer, Shorabuddin Syed, Joseph VanScoy , et al. · 2022

Clinical named entity recognition (NER) is an essential building block for many downstream natural language processing (NLP) applications such as information extraction and de-identification. Recently, deep learning (DL) methods that utili…

Tailoring Rule-Based Data Quality Assessment to the Patient-Centered Outcomes Research Network (PCORnet) Common Data Model (CDM). Open

Yahia Mohamed, Xing Song, Tamara M. McMahon, Suman Sahil, Meredith Zozus , et al. · 2022

Individual researchers and research networks have developed and applied different approaches to assess the data quality of electronic health record (EHR) data. A previously published rules-based method to evaluate the data quality of EHR d…

TAX-Corpus: Taxonomy based Annotations for Colonoscopy Evaluation Open

Shorabuddin Syed, Adam Angel, Hafsa Bareen Syeda, Carole Jennings, Joseph VanScoy , et al. · 2022

Colonoscopy plays a critical role in screening of colorectal carcinomas (CC). Unfortunately, the data related to this procedure are stored in disparate documents, colonoscopy, pathology, and radiology reports respectively. The lack of inte…

The h-ANN Model: Comprehensive Colonoscopy Concept Compilation using Combined Contextual Embeddings Open

Shorabuddin Syed, Adam Angel, Hafsa Bareen Syeda, Carole Jennings, Joseph VanScoy , et al. · 2022

Colonoscopy is a screening and diagnostic procedure for detection of colorectal carcinomas with specific quality metrics that monitor and improve adenoma detection rates. These quality metrics are stored in disparate documents i.e., colono…

Data Management Plan Open

Evaldas Lebedys, Carolyn Famatiga-Fay, Priyanka Bhatkar, Derek Johnson, Gayathri Viswanathan , et al. · 2021

Every clinical study should have prospective plans for how data will be collected, processed and stored. Likewise, every study should have defined data elements and objective evidence of how data were processed. This chapter outlines the p…

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