PMID- 18759506
OWN - NLM
STAT- MEDLINE
DCOM- 20090113
LR  - 20211020
IS  - 0114-5916 (Print)
IS  - 1179-1942 (Electronic)
IS  - 0114-5916 (Linking)
VI  - 31
IP  - 10
DP  - 2008
TI  - An automated standardized system for managing adverse events in clinical research 
      networks.
PG  - 807-22
AB  - Multi-site clinical protocols and clinical research networks require tools to 
      manage and monitor adverse events (AEs). To be successful, these tools must be 
      designed to comply with applicable regulatory requirements, reflect current data 
      standards, international directives and advances in pharmacovigilance, and be 
      convenient and adaptable to multiple needs. We describe an Adverse Event Data 
      Management System (AEDAMS) that is used across multiple study designs in the 
      various clinical research networks and multi-site studies for which we provide 
      data and technological support. Investigators enter AE data using a standardized 
      and structured web-based data collection form. The automated AEDAMS forwards the 
      AE information to individuals in designated roles (investigators, sponsors, Data 
      Safety and Monitoring Boards) and manages subsequent communications in real time, 
      as the entire reporting, review and notification is done by automatically 
      generated emails. The system was designed to adhere to timelines and data 
      requirements in compliance with Good Clinical Practice (International Conference 
      on Harmonisation E6) reporting standards and US federal regulations, and can be 
      configured to support AE management for many types of study designs and adhere to 
      various domestic or international reporting requirements. This tool allows AEs to 
      be collected in a standard way by multiple distributed users, facilitates 
      accurate and timely AE reporting and reviews, and allows the centralized 
      management of AEs. Our design justification and experience with the system are 
      described.
FAU - Richesson, Rachel L
AU  - Richesson RL
AD  - University of South Florida College of Medicine, Tampa, Florida 33612, USA. 
      richesrl@epi.usf.edu
FAU - Malloy, Jamie F
AU  - Malloy JF
FAU - Paulus, Kathleen
AU  - Paulus K
FAU - Cuthbertson, David
AU  - Cuthbertson D
FAU - Krischer, Jeffrey P
AU  - Krischer JP
LA  - eng
GR  - U54 RR019259/RR/NCRR NIH HHS/United States
GR  - RR019259/RR/NCRR NIH HHS/United States
PT  - Journal Article
PT  - Research Support, N.I.H., Extramural
PT  - Research Support, Non-U.S. Gov't
PT  - Review
PL  - New Zealand
TA  - Drug Saf
JT  - Drug safety
JID - 9002928
SB  - IM
MH  - *Adverse Drug Reaction Reporting Systems
MH  - Biomedical Research/methods/statistics & numerical data
MH  - Data Collection/*methods/standards
MH  - Database Management Systems
MH  - Databases as Topic
MH  - Humans
MH  - United States
PMC - PMC6602073
MID - NIHMS1026249
EDAT- 2008/09/02 09:00
MHDA- 2009/01/14 09:00
PMCR- 2019/07/01
CRDT- 2008/09/02 09:00
PHST- 2008/09/02 09:00 [pubmed]
PHST- 2009/01/14 09:00 [medline]
PHST- 2008/09/02 09:00 [entrez]
PHST- 2019/07/01 00:00 [pmc-release]
AID - 31101 [pii]
AID - 10.2165/00002018-200831100-00001 [doi]
PST - ppublish
SO  - Drug Saf. 2008;31(10):807-22. doi: 10.2165/00002018-200831100-00001.