A standard-driven approach for electronic submission to pharmaceutical regulatory authorities
- 1 March 2018
- journal article
- research article
- Published by Elsevier in Journal of Biomedical Informatics
- Vol. 79, 60-70
Abstract
No abstract availableKeywords
Funding Information
- Ministry of Science and Technology (MOST-105-2325-B-002-027)
- Ministry of Health and Welfare (MOHW106-TDU-B-211-113001)
This publication has 8 references indexed in Scilit:
- A multi-technique approach to bridge electronic case report form design and data standard adoptionJournal of Biomedical Informatics, 2015
- Clinical data acquisition standards harmonization importance and benefits in clinical data managementPerspectives in Clinical Research, 2015
- Responses to the Standard for Exchange of Nonclinical Data (SEND) in non-US countriesJournal of Toxicologic Pathology, 2015
- Basics of case report form designing in clinical researchPerspectives in Clinical Research, 2014
- Data standards for clinical research data collection forms: current status and challengesJournal of the American Medical Informatics Association, 2011
- Case report form auto-annotation in PDF files using SAS®ODS XML tagsetsPharmaceutical Programming, 2008
- Data Standards in Clinical Research: Gaps, Overlaps, Challenges and Future DirectionsJournal of the American Medical Informatics Association, 2007
- A Web-based protocol tracking management system for clinical research2004