A web-based medical safety reporting system for a large multicenter clinical trial: The ALIAS experience

Contemporary Clinical Trials

Volumn 31, Issue 6, 2010, Pages 536-543

  Zhao, Wenle ^a   Waldman, Bonnie D ^a   Dillon, Catherine ^a   Pauls, Keith ^a   Kim, Jaemyung ^a   Patterson, Lynn ^a   Ginsberg, Myron D ^b   Hill, Michael D ^c   Palesch, Yuko ^a  

^a MEDICAL UNIVERSITY OF SOUTH CAROLINA   (United States)

^b UNIVERSITY OF MIAMI MILLER SCHOOL OF MEDICINE   (United States)

^c UNIVERSITY OF CALGARY   (Canada)

Author keywords

Clinical trial management system; Electronic safety reporting; MedWatch; System integration; Web based

Indexed keywords

HUMAN ALBUMIN; PLACEBO;

ARTICLE; CLINICAL RESEARCH; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG MEGADOSE; DRUG SURVEILLANCE PROGRAM; ELECTRONIC DATA INTERCHANGE; HUMAN; INFORMATION PROCESSING; INFORMATION RETRIEVAL; INFORMATION STORAGE; INFORMATION SYSTEM; INTERNET; MULTICENTER STUDY; PHASE 3 CLINICAL TRIAL; RANDOMIZED CONTROLLED TRIAL; STROKE; UNSPECIFIED SIDE EFFECT;

ADVERSE DRUG REACTION REPORTING SYSTEMS; ALGORITHMS; CLINICAL TRIALS DATA MONITORING COMMITTEES; HUMANS; INFORMATION MANAGEMENT; INFORMATION SYSTEMS; INTERNET; MULTICENTER STUDIES AS TOPIC; RANDOMIZED CONTROLLED TRIALS AS TOPIC; SAFETY MANAGEMENT; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 77957949198     PISSN: 15517144     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.cct.2010.08.010     Document Type: Article

References (6)

1. Code of Federal Regulations, Title 21, Part 312: Investigational new drug application April 1, 2007, US FDA, HHS.
2. ICH Harmonised Tripartite Guideline, Clinical Safety Data Management: Definitions and Standards for Expedited Reporting E2A, Current Step 4 1994, version dated 27 October 1994.
3. ICH Harmonised Tripartite Guideline, Maintenance of the ICH guideline on clinical safety data management: Data elements for transmission of individual case safety reports E2B(R2) February 2001.
4. ICH Topic E2F, Development Safety Update Report, Step 3, Note for Guidance on Development Safety Update Report June 2008, European Medicines Agency.
5. The Development Safety Update Report (DSUR): Harmonizing the Format and Content for Periodic Safety Reporting During Clinical Trials. Report of CIOMS Working Group VII, Geneva 2007.
6. Merrill Gary H. The MedDRA Paradox. AMIA Annu Symp Proc 2008, 470-474.