Zozus MN, Web-based Electronic Data Capture (EDC): Past, Present and Speculated Future Based on Systematic Review of the Literature. Data Basics, Journal of the Society for Clinical Data Management, Vol. 26: No. 2; Summer 2020. (In Press); Syed, M., Syeda, H.B., Garza, M., Bona, J., Begum, S., Baghal, A., Zozus, M.N., Prior F. (2020). API Driven On-Demand Participant ID Pseudonymization in Heterogeneous Multi-Study Research. Submitted to Healthcare Informatics Research; Zozus, M.N., Topaloglu, U., Collins, C., Hume, S., Cramer, A.E., Simpson, T.D., Williamson, M., Walden, A.C., Garza, M.Y., Rutherford, M., Corey, C., Eisenstein, E.L. (2020). Requirements for Data Acquisition and Use of Electronic Health Record (EHR) Data During Multicenter Clinical Studies. Therapeutic Innovation & Regulatory Science (TIRS), Journal of the Drug Information Association ; Penning, M.L., Newby, K.L., Blach, C., Pieper, C., Walden, A.C. Del Fiol, G., Frund, J., Wang, Z., Wang, P., Syed, M., Syed, S., Zozus, M.N., Donovan, K.M. (2020). Near Real Time HER Data Utilization in a Clinical Study. Stud Health Technol inform; Eisenstein, E.L., Garza, M.Y., Zozus, M.N. (2020). eSource-Enabled vs Traditional Clinical Trial Data Clinical Collection Methods: A Site-Level Economic Analysis. Stud Health Technol Inform; Syed, S., Syed, M., Syed, H.B., Prior, E., Zozus, M.N., Orloff, M. (2020). Document Oriented Graphical Analysis and Prediction: A Site-Level Economic Analysis. Stud Health Technol Inform; Abouelenein, S., Williams, T.B., Baldner, J., Zozus, M.N. (2020). Analysis of Professional Competencies for the Clinical Research Data Management Profession. Data Basics, Journal of the Society for Clinical Data Management ; Wang P, Pullen DL, Garza MY, Zozus MN, Adapting scoring based classification to simplify and automate phenotype creation for cohort identification in clinical data. AMIA Joint Summit on Translational Bioinformatics and Clinical Research Informatics. March 2019. ;Wang, P., Garza, M., Zozus, M. (2019). Cancer phenotype development: A literature review. Studies in Health Technology and Informatics. doi:10.3233/978-1-61499-951-5-468; Nordo A, Eisenstein E, Garza M, W.E. Hammond, Zozus MN, Evaluative outcomes in direct extraction and use of EHR data in clinical trials. Stud Health Technol Inform. 2019; 257:333-340.; Baghal A, Zozus M, Penning M, Syed S, Prior F, Factors associated with increased adoption of a research data warehouse. Stud Health Technol Inform. 2019; 257:31-35.; Garza M, Seker E, Zozus MN, Development of data validation rules for therapeutic area standard data elements to improve the quality of FDA submissions. Stud Health Technol Inform. 2019; 257:125-132.; Garza M, Nordo A, Eisenstein E, Hammond WE, Walden A, Zozus MN, eSource for standardized health information exchange in clinical research: a systematic review. Stud Health Technol Inform. 2019; 257:115-124.; Zozus MN, Young LW, Simon AE, Garza M, Lawrence L, Ounpraseuth ST, Bledsoe M, Nweman-Norlund S, Jarvis JD, McNally M, Harris K, McCulloh R, Aikman R, Cox S, Malloch L, Walden A, Snowden J, Chedjieu IM, Wicker CA, Atkins L, Devlin LA, Training as an intervention to decrease medical record abstraction errors multicenter studies. Stud Health Technol Inform. 2019; 257:526-539.; Bona, J.P., Prior, F.W., Zozus, M.N., Brochhausen, M. (2019). Enhancing Clinical Data and Clinical Research Data with Biomedical Ontologies - Insights from the Knowledge Representation Perspective. Yearbook of medical informatics. doi:10.1055/s-0039-1677912; Penning M, Gadde M, Zozus MN, A Qualitative evidence synthesis of adverse event detection methodologies. Stud Health Technol Inform. 2019; 257:346-51.; Wang P, Pullen D, Garza M, Zozus M, Data profiling in support of entity resolution of multi-institutional EHR data. Stud Health Technol Inform. 2019; 257:479-483.; Williams, TB, Kenney BE, Littleton D, Zozus MN, Assessing the alignment of syllabi components in the expanded biomedical Informatics curriculum: an action research approach. Stud Health Technol Inform. 2019; 257:494-500. ; Wang Z, Dagtas S, Talburt J, Baghal A, Zozus M, Rule-based data quality assessment and monitoring system in healthcare facilities. Stud Health Technol Inform. 2019; 257:460-467; Wang Z, Penning M, Zozus M, Analysis of anesthesia screens for rule-based data quality assessment opportunities. Stud Health Technol Inform. 2019; 257:473-478.;Bonner JD, Sloan R, Bowling C, Stange BJ, Reynolds M, Hartz E, Bignotti DJ, Halimi M, Zozus MN, Atherton D, Landstrom G, Triola N, Interdisciplinary plans of care, electronic medical record systems and inpatient mortality systems research. ACI Open 2018;2: e21–e29.;Williams M, Bagwell J, Zozus M, Data management plans, the missing perspective. Journal of Biomedical Informatics 2017, 71; 130–142.; Callahan TJ, Bauck A, Bertoch D, Brown JS, Khare R, Ryan PB, Staab J, Zozus MN, Kahn MG, A comparison of data quality checks in six data sharing networks. eGEMS, 2017, Vol. 5 No. 1.;Richesson RL, Green BB, Laws R, Puro J, Kahn MG, Bauck A, Smerek M, Van Eaton EG, Zozus M, Hammond WE, Stephens KA, Simon G, Pragmatic (trial) informatics: a perspective from the NIH Health Care Systems Research Collaboratory. J Am Med Inform Assoc. 2017 Sep 1;24(5):996-1001.; Zozus MN, Lazarov A, Smith L, Breen T, Krikorian S, Zbyszewski P, Knoll K, Jendrasek D, Perrin D, Zambas D, Williams T, Pieper C, Analysis of professional competencies for the clinical research data management profession: Implications for training and professional certification. J Am Med Inform Assoc. 2017 Jul 1;24(4):737-745.;Eisenstein EL, Nordo AH, Zozus MN, Using medical informatics to improve clinical trial operations: Workshop Report. Stud Health Technol Inform. 2017; 234:93-97.; Zozus MN, Bonner J, Towards essential metadata for clinical study data. Stud Health Technol Inform. 2017; 234:418-423.;Garza M, Del Fiol G, Tenenbaum J, Walden A, Zozus M. Evaluating common data models for use with a longitudinal community registry. J Biomed Inform. 2016 Dec; 64:333-341.; Eisenstein E., Nordo A., Zozus M., Adams S., Using medical informatics to improve clinical trial operations. European Journal of Epidemiology 2016 31 Supplement 1 (S48).; Kahn MG, Callahan TJ, Barnard JG, Bauck A, Brown JS, Davidson BN, Estiri H, Görg C, Holve E, Johnson SG, Liaw S, Lopez MH, Meeker D, Ong TC, Ryan PB, Shang N, Weiskopf NG, Weng C, Zozus MN, Schilling LM. A harmonized data quality assessment terminology for the secondary use of electronic health record data. eGEMS, 4(1): 1244, 2016. PMC5051581; Zozus MN, Pieper C, Johnson CM, Johnson TR, Franklin A, Smith J, et al. (2015) Factors affecting accuracy of data abstracted from medical records. PLoS ONE 10(10): e0138649. PMC4615628;Kahn MG, Brown JS, Chun AT, Davidson BN, Holve E, Lopez MH, Meeker D, Ryan PB, Schilling LM, Weiskopf NG, Williams AE, Zozus MN, Recommendations for transparent reporting of data quality assessment results for observational healthcare data. eGEMS Journal, 2015; Richesson RL, Hammond WE, Nahm M, Wixted D, Simon GE, Robinson JG, Bauck AE, Cifelli D, Smerek MM, Dickerson J, Laws RL, Madigan RA, Rusincovitch SA, Kluchar C, Califf RM. Electronic health records based phenotyping in next-generation clinical trials: a perspective from the NIH Health Care Systems Collaboratory. J Am Med Inform Assoc. 2013 Dec;20(e2): e226-31. PMID: 23956018; Zozus RT, Bricker A, Lunblad R, Elias D, Nahm M. Taming mental health focused popular literature: A crazy idea? Stud Health Technol Inform. 2013; 183:302-7. PMID: 23388303; Tenenbaum JD, Christian V, Cornish M, Dolor RJ, Dunham AA, Ginsburg GS, Kraus VB, McCarthy JM, McHutchison JG, Nahm ML, Newby KL, Svetkey LP, Udayakumar K, Califf RM. The MURDOCK study: A long-term initiative for disease reclassification through advanced biomarker discovery and integration with electronic health records. Am J Transl Res 2012;4(3):291-301. PMCID: PMC3426390; Bhattacharya S, Dunham AA, Cornish MA, Christian VA, Ginsburg GS, Tenenbaum JD, Nahm ML, Miranda ML, Califf RM, Dolor RJ, Newby KL. The measurement to understand reclassification of disease of cabarrus/Kannapolis (MURDOCK) study community registry and biorepository. Am J Transl Res. 2012;4(4):458–470. PMCID: PMC3493022;Snyder DS, Epps S, Beresford HF, Ennis C, Levens JS, Woody, SK, Tcheng JE, Stacy M, Nahm M. Research management team (RMT): a model for research support services at Duke University. Clin Transl Sci. 2012 Dec;5(6):464-9. PMCID: PMC3531876; Walden A, Nahm M, Barnett ME, Conde J, Dent A, Fadiel A, Perry T, Tolk C, Tcheng J, Eisenstein EL. Economic analysis of centralized vs. decentralized electronic data capture in multi-center clinical studies. Stud Health Technol Inform. 2011; 164:82-8. PMCID: PMC3506018; Nahm M, Shepherd J, Buzenberg A, Rostami R, Corcoran A, McCall J, Pietrobon R. Design and Implementation of an institutional case report form library. Clin Trials. 2011;8(1):94-102. PMCID: PMC3494996; Eisenstein EL, Juzwishin D, Kushniruk AW, Nahm M. Defining a framework for health information technology evaluation. Stud Health Technol Inform. 2011; 164:94-9. PMID: 21335694; Eisenstein EL, Diener LW, Nahm M, Weinfurt KP. Impact of patient-reported outcomes management information system (PROMIS) upon the design and operation of multi-center clinical trials: a qualitative research study. J Med Syst. 2011; 12:35(6):1521-30. PMCID: PMC3588583; Cofiel L, Zammar GR, Zaveri AJ, Shah JY, Carvalho E, Nahm M, Kesselring G, Pietrobon R. A system dynamics analysis determining willingness to wait and pay for the implementation of data standards in clinical research. Health Res Policy Syst. 2010; 12:31:8-38. PMCID: PMC3024294; Nahm M, Walden A, McCourt B, Pieper K, Honeycutt E, Hamilton, CD, Harrington RA, Diefenbach J, Kisler B, Walker M, Hammond WE. Standardizing clinical data elements. Intern J Funct Inform Personal Med (IJFIPM) Special issue on: "The informatics of meta-data, questions, and value sets". 2010;3(4).;Nahm M, Zhang J. Operationalization of the UFuRT methodology for usability analysis in the clinical research data management domain. J Biomed Inform. 2009;42(2):327-33. PMCID: PMC2737809;Rostami R, Nahm M, Pieper CF. What can we learn from a decade of database audits? The Duke Clinical Research Institute experience, 1997-2006, Clin Trials, 2009;6(2):141-50. PMCID: PMC3494997;Sim I, Chute CG, Lehmann H, Nagarajan R, Nahm M, Scheuermann RH. Keeping raw data in context. Science. 2009:323(5915);713. PMID: 19197039;Pan JJ, Nahm M, Wakim P, Cushing C, Poole L, Tai B, Pieper CF. A centralized informatics infrastructure for the National Institute on Drug Abuse Clinical Trials Network. Clin trials. 2009; 6(1):67-75. PMCID: PMC2962616;Bernstam EV, Hersh WR, Johnson SB, Chute CG, Nguyen H, Sim I, Nahm M, Weiner MG, Miller P, DiLaura RP, Overcash M, Lehmann HP, Eichmann D, Athey BD, Scheuermann RH, Anderson N, Starren J, Harris PA, Smith JW, Barbour E, Silverstein JC, Krusch DA, Nagarajan R, Becich MJ. Synergies and distinctions between computational disciplines in biomedical research: perspective from the Clinical and Translational Science Award programs. Acad Med Jul 2009;84(7):964-970. PMCID: PMC2884382; Nahm ML, Pieper CF, Cunningham MM. Quantifying data quality for clinical trials using electronic data capture. PLoS ONE. 2008;3(8): e3049. PMCID: PMC2516178; McCourt B, Harrington R, Fox K, Dukes Hamilton C, Booher K, Hammond W, Walden A, Nahm M. Data standards: at the intersection of sites, clinical research networks, and standards development initiatives, developing and applying clinical data standards. Drug Inf J. 2007; 41:393-404.; Kush R, Alschuler L, Ruggeri R, Cassells S, Gupta N, Bain L, Claise K, Shah M, Nahm M. Implementing single source: the STARBRITE proof-of-concept. JAMIA. 2007;14(5):662-73. PMCID: PMC1975790; Nahm ML, Buchanan CD, Bourham MA, Gilligan JG. Diagnostic modules for tokamak disruption experiments. J Fusion Technol. 1994; 26Nov. 1994.; Bourham MA, Nahm ML, Buchanan CD. Diagnostic DIMES samples for tokamak disruption experiments. Bull Am Phy Soc. 1993;38(10).
