Keyword

SDTM

Description: SDTM, the Study Data Tabulation Model, is a CDISC standard for organizing and submitting clinical trial data in pharmaceutical development.

Primary topic: Statistical Methods in Clinical Trials (21%)

Wikidata ID: wiki/Q7389491

OpenAlex ID: keywords/sdtm

Standardizing registry data to the OMOP Common Data Model: experience from three pulmonary hypertension databases

2021 · Patricia Biedermann, Rose Ong, et al. · BMC Medical Research Methodology · 83

PDF

CDISC Standard-based Electronic Archiving of Clinical Trials

2009 · J. Aerts, S. C. Semler, et al. · Methods of Information in Medicine · 61

Central site monitoring: Results from a test of accuracy in identifying trials and sites failing Food and Drug Administration inspection

2013 · Anne S Lindblad, Zorayr Manukyan, et al. · Clinical Trials · 48

Evolution and Implementation of the CDISC Study Data Tabulation Model (SDTM)

2008 · Fred Wood, Tom Guinter · Pharmaceutical Programming · 18

SQL-like big data environments: Case study in clinical trial analytics

2015 · Akshay Grover, Jay Gholap, et al. · IEEE International Conference on Big Data (BigData) · 17

Toward a Comprehensive CDISC Submission Data Standard

2007 · Wayne R. Kubick, Stephen Ruberg, et al. · Drug Information Journal · 17

Data Standardization, Pharmaceutical Drug Development, and the 3Rs

2016 · Laura Kaufman, Katrina Gore, et al. · ILAR Journal · 14

PDF

CDISC Transformer: a metadata-based transformation tool for clinical trial and research data into CDISC standards

2011 · Yu Rang Park · KSII Transactions on Internet and Information Systems · 14

PDF

The Back Pain Consortium (BACPAC) Research Program Data Harmonization: Rationale for Data Elements and Standards

2023 · Anna Batorsky, Anton E Bowden, et al. · Pain Medicine · 13

PDF

The Standard for the Exchange of Nonclinical Data (SEND): Challenges and Promises

2018 · Shambhunath Choudhary, Audrey Walker, et al. · Toxicologic Pathology · 13

PDF

Responses to the Standard for Exchange of Nonclinical Data (SEND) in non-US countries

2015 · Takayuki Anzai, Masamichi Kaminishi, et al. · Journal of Toxicologic Pathology · 11

PDF

Controlled Terminology for Clinical Research: A Collaboration between CDISC and NCI Enterprise Vocabulary Services

2007 · Margaret W. Haber, Bron W. Kisler, et al. · Drug Information Journal · 10

Clinical Data Interchange Standards Consortium Standardization of Biobank Data: A Feasibility Study

2015 · Izumi Sato, Yohei Kawasaki, et al. · Biopreservation and Biobanking · 9

IT solutions for imaging biomarkers in biopharmaceutical research and development

2007 · M. Hehenberger, A. Chatterjee, et al. · IBM Systems Journal · 8

A use-case analysis of Clinical Data Interchange Standards Consortium/Study Data Tabulation Model in academia in an investigator-initiated clinical trial.

2022 · Shizuko Takahara, Toshiki I Saito, et al. · PubMed · 6

Implementation of Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM) in Investigator-Initiated Studies on Hematologic Malignancies

2022 · Matsuo Yamamoto, Kaori Nagai, et al. · SSRN Electronic Journal · 5

Streamlined Operational Approaches and Use of e-Technologies in Clinical Trials: Beat Acute Myeloid Leukemia Master Trial

2021 · Len Rosenberg, Hugh Levaux, et al. · Therapeutic Innovation & Regulatory Science · 5

PDF

International Harmonization of Nomenclature and Diagnostic Criteria (INHAND) for Lesions in the Minipig

2015 · Mikala Skydsgaard · Toxicologic Pathology · 5

Brave New World: How to Adapt to the CDISC Statistical Computing Environment

2011 · Jeff Abolafia, Frank DiIorio · 5

Interoperability of Leigh Syndrome Patient Registry Data with Regulatory Submission Standards

2023 · Parag Shiralkar, Pallavi Bakare, et al. · Journal of the Society for Clinical Data Management · 4

Comparing SDTM and FHIR® for Real World Data from Electronic Health Records for Clinical Trial Submissions

2021 · Sarah Riepenhausen, Cornelia Mertens, et al. · Studies in health technology and informatics · 4

PDF

PhUSE De-Identification Working Group: Providing De-Identification Standards to CDISC Data Models

2015 · Jean-Marc Ferran, Sarah Nolan, et al. · 4

Using the SAS ® Clinical Standards Toolkit 1.4 for define.xml creation

2011 · Lex Jansen · 4

CDISC-compliant clinical trial imaging management system with automatic verification and data Transformation: Focusing on tumor response assessment data in clinical trials

2021 · Amy Junghyun Lee, Kyung Won Kim, et al. · Journal of Biomedical Informatics · 3

PDF

Supporting CDISC Standards in Base SAS Using the SAS Clinical Standards Toolkit

2009 · P.G.R de Villiers · 3

Works count: 309

Citation count: 429