Building the technical infrastructure to support a study on drug safety in a general hospital

Studies in Health Technology and Informatics

Volumn 169, Issue , 2011, Pages 325-329

  Kirchner, Melanie ^a   Bürkle, Thomas ^a   Patapovas, Andrius ^a   Mathews, Anja ^a,b   Sojer, Reinhold ^a   Müller, Fabian ^a   Dormann, Harald ^b   Maas, Renke ^a   Prokosch, Hans Ulrich ^a  

^a UNIVERSITY OF ERLANGEN NUREMBERG   (Germany)

^b KLINIKUM FÜRTH   (Germany)

Author keywords

Clinical Trial; Digital Pen; Drug Safety Research; Electronic Data Capture; Technical Infrastructure

Indexed keywords

CLINICAL RESEARCH; DRUG THERAPY; HOSPITALS;

CLINICAL TRIAL; DIGITAL PENS; DRUG SAFETY; ELECTRONIC DATA; TECHNICAL INFRASTRUCTURE;

SAFETY ENGINEERING;

EID: 83055187679     PISSN: 09269630     EISSN: 18798365     Source Type: Book Series    
DOI: 10.3233/978-1-60750-806-9-325     Document Type: Conference Paper

References (14)

1. Lazarou J, Pomeranz B, Corey P. Incidence of adverse drug reactions in hospitalized patients, JAMA 279 (15) (1998), 1200-1205
2. Wester K, Jönsson A, Spigset O, et al. Incidence of Fatal Adverse Drug Reactions. British Journal of Clinical Pharmacology (2008), 573-579
3. Winterstein AG, Sauer BC, Hepler CD, et al. Preventable drug-related hospital admissions, The Annals of Pharmacotherapy 36 (2002), 1238-1248 (Pubitemid 34755803)
4. Web url: http://www.anoto.com/the-pen-2.aspx
5. Naranjo CA, Busto U, Sellers EM, et al. A Method for Estimating the Probability of Adverse Drug Reactions, Clinical Pharmacology and Therapeutics 30 (1981), 239-245 (Pubitemid 12149145)
6. Web url: http://ctep.cancer.gov/protocolDevelopment/electronic- applications/ctc.htm
7. Guideline to Good Clinical Practice, European Medicines Agency, 2002
8. Pommerening K, Reng M, Secondary Use of the EHR Pseudonymisation, Medical Care Compunatics 1 (2004), 441-446
9. Web url: http://www.greasespot.net/
10. Dugas M, Breil B, Thiemann V. Single Source Information Systems to Connect Patient Care and Clinical Research, Medical Informatics in a United and Healthy Europe, IOS Press (2009)
11. Safran C. Using Routinely Collected Data for Clinical Research, Statistics in Medicine 10 (1991), 559-564
12. Pavlovic I, Miklavcic D. Web-based Electronic Data Collection System to Support Electrochemotherapy Clinical Trial, IEEE Transactions on Information Technology in Biomedicine 11 (2007), 222-230 (Pubitemid 46523139)
13. Brandt CA, Deshpande AM, Lu C, et al. TrialDB: A Web-based Clinical Study Data Management System, Amia Symposium Proceedings (2003), 794
14. Web url: http://www.german-coalition-for-patient-safety.org/