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Data Capture, Data Management, and Quality Control; Single Versus Multicenter Trials

  • Kristin KnustEmail author
  • Lauren Yesko
  • Ashley Case
  • Kate Bickett
Living reference work entry
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Abstract

Data capture, data management, and quality control processes are instrumental to the conduct of clinical trials. Obtaining quality data requires numerous considerations throughout the life cycle of the trial. Case report form design and data capture methodology are crucial components that ensure data are collected in a streamlined and accurate manner. Robust data quality and validation strategies must be employed early on in data collection to identify potential systemic errors. Data management guidance documents provide an opportunity to set clear expectations for stakeholders and establish communication pathways. These tools need to be supplemented with adequate training and ongoing support of trial staff. Trials may be conducted in a single or multicenter setting, which has implications for data management. Risk-based monitoring is one approach that can help data managers target quality issues in a multicenter setting. Evolving technologies such as electronic medical record and electronic data capture system integration, artificial intelligence, and big data analytics are changing the landscape of data capture and management.

Keywords

Data management Data collection Data quality Multicenter trial Case report form (CRF) Risk-based monitoring (RBM) Data review Electronic medical record (EMR) Electronic data capture (EDC) 

References

  1. Baigent C, Harrel F, Buyse M, Emberson J, Altman D (2008) Ensuring trial validity by data quality assurance and diversification of monitoring methods. Clin Trials 5:49–55CrossRefGoogle Scholar
  2. Chen Y, Argentinis JD, Weber G (2016) IBM Watson: how cognitive computing can be applied to big data challenges in life sciences research. Clin Ther 38(4):688CrossRefGoogle Scholar
  3. Food and Drug Administration (2013) FDA guidance oversight of clinical investigations – a risk-based approach to monitoring. https://www.fda.gov/downloads/Drugs/Guidances/UCM269919.pdf
  4. Food and Drug Administration (2018) FDA guidance clinical trial endpoints for the approval of cancer drugs and biologics: guidance for industry. https://www.fda.gov/downloads/Drugs/Guidances/ucm071590.pdf
  5. Gaddale JR (2015) Clinical data acquisition standards harmonization importance and benefits in clinical data management. Perspect Clin Res 6(4):179–183CrossRefGoogle Scholar
  6. Goodman K, Krueger J, Crowley J (2012) The automatic clinical trial: leveraging the electronic medical record in multi-site cancer clinical trials. Curr Oncol Rep 14(6):502–508CrossRefGoogle Scholar
  7. International Conference on Harmonisation (2018) Guideline for good clinical practice E6(R2) good clinical practice: integrated addendum to ICH E6(R1) guidance for industry. https://www.fda.gov/downloads/Drugs/Guidances/UCM464506.pdf
  8. Johnson K, Soto JT, Glicksberg BS, Shameer K, Miotto R, Ali M, Ashley E, Dudley JT (2018) Artificial intelligence in cardiology. J Am Coll Cardiol 71:2668–2679CrossRefGoogle Scholar
  9. Khaloufi H, Abouelmehdi K, Beni-Hssane A, Saadi M (2018) Security model for big healthcare data lifecycle. Procedia Comput Sci 141:294–301CrossRefGoogle Scholar
  10. Krishnankutt B, Bellary S, Kumar N, Moodahadu L (2012) Data management in clinical trial: an overview. Indian J Pharmacol 44(2):168–172CrossRefGoogle Scholar
  11. McFadden E (2007) Management of data in clinical trials, 2nd edn. Hoboken, NJ: Wiley-Interscience.Google Scholar
  12. Meinert CL, Tonascia S (1986) Clinical trials: design, conduct, and analysis. New York: Oxford University Press.CrossRefGoogle Scholar
  13. Nahm M, Shepherd J, Buzenberg A, Rostami R, Corcoran A, McCall J et al (2011) Design and implementation of an institutional case report form library. Clin Trials 8:94–102CrossRefGoogle Scholar
  14. Reboussin D, Espeland MA (2005) The science of web-based clinical trial management. Clin Trials 2:1–2CrossRefGoogle Scholar
  15. Richesson RL, Nadkarni P (2011) Data standards for clinical research data collection forms: current status and challenges. J Am Med Inform Assoc 18:341–346CrossRefGoogle Scholar
  16. Williams G (2006) The other side of clinical trial monitoring; assuring data quality and procedural adherence. Clin Trials 3:530–537CrossRefGoogle Scholar

Copyright information

© Springer Nature Switzerland AG 2020

Authors and Affiliations

  • Kristin Knust
    • 1
    Email author
  • Lauren Yesko
    • 1
  • Ashley Case
    • 1
  • Kate Bickett
    • 1
  1. 1.EmmesRockvilleUSA

Section editors and affiliations

  • Eleanor McFadden
    • 1
  1. 1.Frontier Science (Scotland) Ltd, Grampian ViewKincraigUK

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