![Page 1: Database Design for Clinical Trial Xiaoqing He & Gilsinia Lopez [1,2]](https://reader035.vdocuments.us/reader035/viewer/2022062421/56649dc55503460f94ab8521/html5/thumbnails/1.jpg)
Database Design for Clinical Database Design for Clinical TrialTrial
Xiaoqing He & Gilsinia Lopez
[1,2]
![Page 2: Database Design for Clinical Trial Xiaoqing He & Gilsinia Lopez [1,2]](https://reader035.vdocuments.us/reader035/viewer/2022062421/56649dc55503460f94ab8521/html5/thumbnails/2.jpg)
GoalsGoalsBuild an essential online resource
for tracking side effects of $1 trillion worth of prescription meds sold around the world
Applications for both healthcare professionals and patients
Increase transparency throughout the healthcare and pharmaceutical industries
![Page 3: Database Design for Clinical Trial Xiaoqing He & Gilsinia Lopez [1,2]](https://reader035.vdocuments.us/reader035/viewer/2022062421/56649dc55503460f94ab8521/html5/thumbnails/3.jpg)
![Page 4: Database Design for Clinical Trial Xiaoqing He & Gilsinia Lopez [1,2]](https://reader035.vdocuments.us/reader035/viewer/2022062421/56649dc55503460f94ab8521/html5/thumbnails/4.jpg)
Current statusCurrent status75 % data capture – paper basedData inconsistenciesData Entry errorOnly 10 percent of data are reported
SolutionSolution
Electronic data capture – eCRF
![Page 5: Database Design for Clinical Trial Xiaoqing He & Gilsinia Lopez [1,2]](https://reader035.vdocuments.us/reader035/viewer/2022062421/56649dc55503460f94ab8521/html5/thumbnails/5.jpg)
![Page 6: Database Design for Clinical Trial Xiaoqing He & Gilsinia Lopez [1,2]](https://reader035.vdocuments.us/reader035/viewer/2022062421/56649dc55503460f94ab8521/html5/thumbnails/6.jpg)
Problems with eCRFProblems with eCRFIncompleteFilled with misspelling MisclassificationOut of date
![Page 7: Database Design for Clinical Trial Xiaoqing He & Gilsinia Lopez [1,2]](https://reader035.vdocuments.us/reader035/viewer/2022062421/56649dc55503460f94ab8521/html5/thumbnails/7.jpg)
Adverse Events Inc. (RxFilter Adverse Events Inc. (RxFilter ™) ™) RxFilter – 17 step data
normalization processNormalizes the FDA’s adverse
events reports into a single report, and standardizes the data for improved accuracy of adverse drug event information
![Page 8: Database Design for Clinical Trial Xiaoqing He & Gilsinia Lopez [1,2]](https://reader035.vdocuments.us/reader035/viewer/2022062421/56649dc55503460f94ab8521/html5/thumbnails/8.jpg)
![Page 9: Database Design for Clinical Trial Xiaoqing He & Gilsinia Lopez [1,2]](https://reader035.vdocuments.us/reader035/viewer/2022062421/56649dc55503460f94ab8521/html5/thumbnails/9.jpg)
![Page 10: Database Design for Clinical Trial Xiaoqing He & Gilsinia Lopez [1,2]](https://reader035.vdocuments.us/reader035/viewer/2022062421/56649dc55503460f94ab8521/html5/thumbnails/10.jpg)
![Page 11: Database Design for Clinical Trial Xiaoqing He & Gilsinia Lopez [1,2]](https://reader035.vdocuments.us/reader035/viewer/2022062421/56649dc55503460f94ab8521/html5/thumbnails/11.jpg)
![Page 12: Database Design for Clinical Trial Xiaoqing He & Gilsinia Lopez [1,2]](https://reader035.vdocuments.us/reader035/viewer/2022062421/56649dc55503460f94ab8521/html5/thumbnails/12.jpg)
Achievements and Claims of Achievements and Claims of Adverse Events Inc. Adverse Events Inc. Lamictal and Keppra, which are classified
as may be “as dangerous to a fetus as drugs currently listed” should be placed in a more risky category
measure medication side effects and ensure high quality standards to protect patient safety
supports companies with competitive intelligence and data to inform drug marketing decisions and business development strategies.
![Page 13: Database Design for Clinical Trial Xiaoqing He & Gilsinia Lopez [1,2]](https://reader035.vdocuments.us/reader035/viewer/2022062421/56649dc55503460f94ab8521/html5/thumbnails/13.jpg)
Relationship With Course
Relevant to chapters of Conceptual modeling and Relational Database Design
Data collecting, Standardizes and Normalizes the data
Basic of Functional Dependencies and Normalization
![Page 14: Database Design for Clinical Trial Xiaoqing He & Gilsinia Lopez [1,2]](https://reader035.vdocuments.us/reader035/viewer/2022062421/56649dc55503460f94ab8521/html5/thumbnails/14.jpg)
Reference
[1]Luke Timmerman, Biotech, Startups, IT, Sep. 2011,
http://www.xconomy.com/san-francisco/2011/09/27/adverseevents-com-seeks-to-keep-track-of-drug-side-effects-the-way-the-fda-never-could/
[2]Business Wire, Sep. 2011,
http://www.businesswire.com/news/home/20110926005053/en/AdverseEvents-Launches-Innovative-Comparative-Drug-Side-Effect
[3]Picture 3-6 is from http://adverseevents.com/drugdetail.php?AEDrugID=807&BrandName=LIPITOR
[4]Picture 1 is from http://www.drofdetox.com/overview-of-clinical-trial/
[5]Picture 2 is from http://www.ecrf.biz.pl/about_en.htm