The Grammar of Science: It’s All about Trustworthiness of Your Data

Authors

  • Jaranit Kaewkungwal Mahidol University

DOI:

https://doi.org/10.59096/osir.v17i3.270958

Abstract

-

References

International council for harmonization of technical requirements for pharmaceuticals for human use: good clinical practice E6(R3). [cited 2024, August 15]. 73 p. <https://database.ich.org/sites/default/files/ICH_E6%28R3%29_DraftGuideline_2023_0519.pdf>

World Health Organization. WHO expert committee on specifications for pharmaceutical preparations: fifty-fifth report [Internet]. Geneva: World Health Organization; 2021. Annex 4: guideline on data integrity; [cited 2024 Aug 15]; p 135–159. <https://cdn.who.int/media/docs/default-source/medicines/norms-and-standards/guidelines/inspections/trs1033-annex4-guideline-on-data-integrity.pdf?>

U.S. Food and Drug Administration. Data integrity and compliance with drug CGMP: questions and answers [Internet]. Silver Spring (MD): U.S. Food and Drug Administration; 2018 Dec [cited 2024 Aug 15] <https://www.fda.gov/regulatory-information/search-fda-guidance-documents/data-integrity-and-compliance-drug-cgmp-questions-and-answers>

European Medicines Agency. Guidance on good manufacturing practice and good distribution practice: questions and answers [Internet]. Amsterdam: European Medicines Agency; [cited 2024 Aug 15] <https://www.ema.europa.eu/en/human-regulatory-overview/research-development/compliance-research-development/good-manufacturing-practice/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers#data-integrity-7108>

Office for Statistics Regulation, UK Statistics Authority. Code of Practice for statistics: Trustworthiness [Internet]. London: UK Statistics Authority; [cited 2024 Aug 15]. <https://code.statisticsauthority.gov.uk/the-code/trustworthiness/>

Atlan. Data governance vs. data management: what’s the difference? [Internet]. Singapore: Atlan Technologies; [updated 2023 Apr 3; cited 2024 Aug 15]. <https://atlan.com/data-governance-vs-data-management/>

Atlan. Data quality in data governance: the crucial link that ensures data accuracy and integrity [Internet]. Singapore: Atlan Technologies; [updated 2023 Jul 24; cited 2024 Aug 15]. <https://atlan.com/data-quality-in-data-governance/>

DQLabs. Challenges and best practices of data cleansing [Internet]. Pasadena (CA): DQLabs; [cited 2024 Aug 15]. <https://www.dqlabs.ai/blog/challenges-and-best-practices-of-data-cleansing/>

Bothra R. Data quality management techniques and best practices [Internet]. San Francisco: Hevo Data Inc; 2024 May 3 [cited 2024 Aug 15]. <https://hevodata.com/learn/what-is-data-quality-management/>

Collibra. Data quality and data governance: where to begin? [Internet]. New York: Collibra; [updated 2023 Dec 14; cited 2024 Aug 15]. <https://www.collibra.com/us/en/blog/data-quality-vs-data-governance>

Tableau. Data management vs. data governance: the difference explained [Internet]. Seattle: Tableau Software; [cited 2024 Aug 15]. <https://www.tableau.com/learn/articles/data-management-vs-data-governan>

Mucci T, Stryker C. What is data integrity? [Internet]. New York: IBM; 2024 Apr 5 [cited 2024 Aug 15]. <https://www.ibm.com/topics/data-integrity>

Loshin D. The practitioner's guide to data quality improvement [Internet]. Philadelphia: Elsevier Inc; 2011 [cited 2024 Aug 15]. <https://www.sciencedirect.com/book/9780123737175/the-practitioners-guide-to-data-quality-improvement>

Pharmaceutical Consultancy Services. The difference between ALCOA and ALCOA+ (plus) [Internet]. Woerden: Pharmaceutical consultancy, training and audits; 2023 Oct 30 [cited 2024 Aug 15]. <https://www.pcs-nl.com/en/post/difference-between-alcoa-and-alcoa-plus>

Novogroder I. Data quality management: tools, pillars, and best practices. Campbell (CA): lakeFS; 2023 Nov 30 [cited 2024 Aug 15]. <https://lakefs.io/data-quality/data-quality-management/>

Cantor K. What Is the difference between data cleaning and data cleansing? [Internet]. Indianapolis: P3Adaptive; 2024 May 27 [cited 2024 Aug 15]. <https://p3adaptive.com/what-is-the-difference-between-data-cleaning-and-data-cleansing/>

DQOps. Data cleaning vs data cleansing [Internet]. Warsaw: DQOps; [updated 2024 Jun 24; cited 2024 Aug 15]. <https://dqops.com/data-cleaning-vs-data-cleansing/>

Acceldata. What is data quality management? Campbell (CA): Acceldata; 2024 May 3 [cited 2024 Aug 15]. <https://www.acceldata.io/article/what-is-data-quality-management>

Qualifyze. What is ALCOA data integrity? [Internet]. Frankfurt: Qualifyze; 2022 Oct 11 [cited 2024 Aug 15]. <https://www.qualifyze.com/resources/blog/what-is-alcoa-data-integrity/>

Society for Clinical Data Management. Good clinical data management practices (2024 edition). Brussels: Society for Clinical Data Management; [cited 2024 Aug 15]. <https://scdm.org/gcdmp/>

Actian. What is data quality management? [Internet]. Santa Clara (CA): Actian Corporation; [cited 2024 Aug 15]. <https://www.actian.com/what-is-data-quality-management/>

Bauman J. Data quality management: what you need to know [Internet]. Cary: SAS Institute Inc; [cited 2024 Aug 15]. <https://www.sas.com/en_th/insights/articles/data-management/data-quality-management-what-you-need-to-know.html>

Rondel RK, Varley SA, Webb CF. Clinical data management. 2nd ed. New York: John Wiley & Sons, Ltd: 2000. 368 p.

Published

2024-09-24

How to Cite

Kaewkungwal, J. (2024). The Grammar of Science: It’s All about Trustworthiness of Your Data. Outbreak, Surveillance, Investigation & Response (OSIR) Journal, 17(3), 165–172. https://doi.org/10.59096/osir.v17i3.270958

Issue

Section

Invited article