Abstract
Effective pharmacovigilance requires ease of access to all sources of pertinent safety data. For drugs under development or recently launched, the clinical trial database represents a vital source of safety information. However, the responsibility for the clinical safety database typically lies outside of the control of the safety department. Similarly, for a recently launched drug, noninterventional prospective studies are another source of important safety data, and also the data regarding these studies typically lies outside of the safety department. Access to clinical trial and observational safety data varies between organisations, but it is evident that direct and open access for pharmacovigilance is atypical despite this data being essential for drug safety to continuously assess the safety profile of a drug.
This is a preview of subscription content, log in via an institution to check access.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
References
Heads of Medicines Agencies, European Medicines Agency. Guideline on Good Vigilance Practices (2014) Module VI – Management and reporting of adverse reactions to medicinal products (Rev1). 08 September 2014 EMA/873138/2011 Rev 1
CDASH-E2B Project Team (2013) CDASH serious adverse event supplement. 25 Nov 2013. CDISC
International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (2014) Data elements for the transmission of individual case safety reports E2B(R3). Current step 5 version dated November 2014
International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (2010) Developmental safety update report E2F. Current step 4 version dated 17 Aug 2010
International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. Periodic benefit-risk evaluation report E2C(R2). Current step 4 version dated 4 Dec 2012
Heads of Medicines Agencies, European Medicines Agency (2012) Guideline on good vigilance practices. Module XI – Signal management. 22 June 2012. EMA/827611/2011
European Commission (2011) Detailed guidance on the collection, verification and presentation of the adverse event/reaction reports arising from clinical trials on medicinal products (CT-3). Off J Eur Union. 11 June 2011. C 172/1
U.S. Department of Health and Human Services Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER) (2012) Guidance for Industry and Investigators. Safety reporting for INDs and BA/BE studies
European Medicines Agency (2012) European Medicines Agency acts on deficiencies in Roche medicines-safety reporting. Press release 21 June 2012. EMA/405725/2012
Medical Dictionary for Regulatory Activities Terminology Maintenance and Support Organization (2015) Introductory guide MedDRA version 18.0
Burnstead B, Furlan G (2013) Unifying drug safety and clinical databases. Curr Drug Saf 8:56–62
Bates DW, Gwanda AA (2003) Improving safety with information technology. N Engl J Med 348:2526–2534
El Emam K, Jonker E, Sampson M, Krleža-Jerić K, Neisa A (2009) The use of electronic data capture tools in clinical trials: web-survey of 259 canadian trials. J Med Internet Res 11(1):e8. http://www.jmir.org/2009/1/e8
Lu Z, Su J (2010) Clinical data management: current status, challenges and future directions from an industry perspective. J Clin Trials 2:93–105
US FDA website. Study Data Standards for Submission to CDER. Last updated 18 Dec 2014. Accessed on 5 Sept 2015 at: http://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/ucm248635.htm
Define XML Core Team (representing CDISC) (2013) Define XML version 2.0. March 2013 (Case Report Tabulations).Open Source available on CDISC website
CDASH Core Team (Representing CDISC) (2008) Clinical Data Acquisition Standards Harmonization (CDASH). 1 Oct 2008. Open source available on CDISC website
International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (2001) Data elements for the transmission of individual case safety reports E2B(R2). Current step 4 version dated 5 Feb 2001
International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use Pharmacovigilance Planning E2E (2014) Current step 4 version dated 18 Nov 2014
Heads of Medicines Agencies, European Medicines Agency (2013) Guideline on good vigilance practices. Module VIII – post-authorization safety studies (Rev 1). 19 Apr 2013. EMA/813938/2011 Rev 1
Acknowledgements
The authors would like to thank Mr. David Power, Helsinn Birex Pharmaceuticals, for reviewing this chapter.
Author information
Authors and Affiliations
Corresponding author
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 2017 Springer International Publishing Switzerland
About this chapter
Cite this chapter
Furlan, G., Burnstead, B. (2017). The Unified Drug Safety-Clinical Database. In: Edwards, I., Lindquist, M. (eds) Pharmacovigilance. Adis, Cham. https://doi.org/10.1007/978-3-319-40400-4_7
Download citation
DOI: https://doi.org/10.1007/978-3-319-40400-4_7
Published:
Publisher Name: Adis, Cham
Print ISBN: 978-3-319-40399-1
Online ISBN: 978-3-319-40400-4
eBook Packages: MedicineMedicine (R0)