Integrated data management for clinical studies: Automatic transformation of data models with semantic annotations for principal investigators, data managers and statisticians

PLoS ONE

Volumn 9, Issue 2, 2014, Pages

  Dugas, Martin ^a   Dugas Breit, Susanne ^b  

^a UNIVERSITY OF MÜNSTER   (Germany)

^b UNIVERSITY OF MUNICH   (Germany)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; CLINICAL STUDY; DATA PROCESSING; INFORMATION PROCESSING; MEDICAL INFORMATICS; PROFESSIONAL STANDARD; SEMANTICS; STATISTICAL CONCEPTS; COMPUTER PROGRAM; ELECTRONIC MEDICAL RECORD; HUMAN; INFORMATION RETRIEVAL; INTERNET; MEDICAL RESEARCH; PERSONNEL; PROCEDURES; REPRODUCIBILITY; STATISTICS AND NUMERICAL DATA;

BIOMEDICAL RESEARCH; HUMANS; INFORMATION STORAGE AND RETRIEVAL; INTERNET; MEDICAL INFORMATICS COMPUTING; MEDICAL RECORDS SYSTEMS, COMPUTERIZED; REPRODUCIBILITY OF RESULTS; RESEARCH PERSONNEL; SOFTWARE;

EID: 84896521281     PISSN: None     EISSN: 19326203     Source Type: Journal    
DOI: 10.1371/journal.pone.0090492     Document Type: Article

References (23)

1. Getz K (2008) Protocol Design Trends and their Effect on Clinical Trial Performance. RAJ Pharma 5: 315-316.
2. Hearn J, Sullivan R (2007) The impact of the 'Clinical Trials' directive on the cost and conduct of non-commercial cancer trials in the UK. Eur J Cancer 43(1): 8-13. (Pubitemid 46054481)
3. Stewart DJ, Whitney SN, Kurzrock R (2010) Equipoise lost: ethics, costs, and the regulation of cancer clinical research. J Clin Oncol. 28(17): 2925-35.
4. Food and Drug Administration. Available: http://www.fda.gov/. (accessed July 26, 2013).
5. European Medicines Agency. Available: http://www.ema.europa.eu/. (accessed July 26, 2013).
6. CDISC Operational Data Model (ODM) Available: http://www.cdisc.org/ odm. (accessed December 3, 2013).
7. medidata Rave(R). Available: http://www.mdsol.com/products/rave-overview. htm. (accessed July 26, 2013).
8. XClinical Marvin. Available: http://www.xclinical.com/en/marvin/. (accessed July 26, 2013).
9. secuTrial(R). Available: http://www.secutrial.com/. (accessed July 26, 2013).
10. Bruland P, Breil B, Fritz F, Dugas M (2012) Interoperability in Clinical Research: From Metadata Registries to Semantically Annotated CDISC ODM. Stud Health Technol Inform 180: 564-8.
11. SAS. Available: http://www.sas.com/software/sas9/. (accessed July 26, 2013).
12. IBM-SPSS. Available: http://www-01.ibm.com/software/analytics/spss/. (accessed July 26, 2013).
13. R Core Team (2013). R: A language and environment for statistical computing. R Foundation for Statistical Computing, Vienna, Austria. Available: http:// www.R-project.org/. (accessed July 26, 2013).
14. S-Plus. Available: http://de.wikipedia.org/wiki/S-Plus. (accessed July 26, 2013).
15. SNOMED CT. Available: http://www.ihtsdo.org/snomed-ct/. (accessed July 26, 2013).
16. LOINC. Available: http://loinc.org/. (accessed July 26, 2013).
17. UMLS. Available: http://www.nlm.nih.gov/research/umls/. (accessed July 26, 2013).
18. Breil B, Kenneweg J, Fritz F, Bruland P, Doods J, et al. (2012) Multilingual Medical Data Models in ODM Format. A Novel Form-based Approach to Semantic Interoperability between Routine Healthcare and Clinical Research. ACI 3(3): 276-289.
19. NCImetathesaurus. Available: http://ncim.nci.nih.gov/ncimbrowser/. (accessed July 26, 2013).
20. Portal of Medical Data Models. Available: http://www.medical-data-models. org/. (accessed July 26, 2013).
21. Dugas M, Fritz F, Krumm R, Breil B (2013) Automated UMLS-based Comparison of Medical Forms. PLoS ONE 8(7): e67883.
22. U.S. NIH ClinicalTrials.Gov. Available: http://clinicaltrials.gov/. (accessed July 26, 2013).
23. MedDRA. Available: http://www.meddra.org/. (accessed July 26, 2013).