Abstract
An electronic safety reporting (ESR) module was developed and integrated into a home-grown web-based clinical trial management system (CTMS) to enhance the efficiency, completeness and consistency of reporting and reviewing serious adverse events, monitoring safety, and submitting safety reports to regulatory authorities for a large multicenter clinical trial. The architecture of this integrated module provided many advantages. First, the ESR module was developed based on a comprehensive procedure which incorporated both computer logic processing steps and human intervention steps in order to deal with the complex and unexpected situations where pre-programmed computer logic may fail. Second, safety and efficacy data were managed within the same relational database. Relevant data captured on efficacy case report forms, such as demographics, medical history, lab data and concomitant medications, were directly retrievable for MedWatch report composition without requiring redundant data entry. Finally, the ESR module shared the same generic user interfaces and data processing functions with other modules in the CTMS. These generic components include data editing, data retrieving, data reporting, dictionary-based automatic and interactive coding, event-driven and calendar-driven automatic email notifications, and user privilege management. This integrated ESR module was implemented in the Albumin in Acute Stroke (ALIAS) Trial-Part 1. A total of 397 serious adverse event reports were processed and 33 FDA MedWatch reports, 28 initial reports, and 5 follow-up reports were submitted to FDA and Health Canada using this system. Experiences and lessons learned from the development and implementation of this system are presented in this paper.
| Original language | English |
|---|---|
| Pages (from-to) | 536-543 |
| Number of pages | 8 |
| Journal | Contemporary Clinical Trials |
| Volume | 31 |
| Issue number | 6 |
| DOIs | |
| State | Published - Nov 1 2010 |
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Keywords
- Clinical trial management system
- Electronic safety reporting
- MedWatch
- System integration
- Web based
ASJC Scopus subject areas
- Pharmacology (medical)
- Medicine(all)
Cite this
A web-based medical safety reporting system for a large multicenter clinical trial : The ALIAS experience. / Zhao, Wenle; Waldman, Bonnie D.; Dillon, Catherine; Pauls, Keith; Kim, Jaemyung; Patterson, Lynn; Ginsberg, Myron; Hill, Michael D.; Palesch, Yuko.
In: Contemporary Clinical Trials, Vol. 31, No. 6, 01.11.2010, p. 536-543.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - A web-based medical safety reporting system for a large multicenter clinical trial
T2 - The ALIAS experience
AU - Zhao, Wenle
AU - Waldman, Bonnie D.
AU - Dillon, Catherine
AU - Pauls, Keith
AU - Kim, Jaemyung
AU - Patterson, Lynn
AU - Ginsberg, Myron
AU - Hill, Michael D.
AU - Palesch, Yuko
PY - 2010/11/1
Y1 - 2010/11/1
N2 - An electronic safety reporting (ESR) module was developed and integrated into a home-grown web-based clinical trial management system (CTMS) to enhance the efficiency, completeness and consistency of reporting and reviewing serious adverse events, monitoring safety, and submitting safety reports to regulatory authorities for a large multicenter clinical trial. The architecture of this integrated module provided many advantages. First, the ESR module was developed based on a comprehensive procedure which incorporated both computer logic processing steps and human intervention steps in order to deal with the complex and unexpected situations where pre-programmed computer logic may fail. Second, safety and efficacy data were managed within the same relational database. Relevant data captured on efficacy case report forms, such as demographics, medical history, lab data and concomitant medications, were directly retrievable for MedWatch report composition without requiring redundant data entry. Finally, the ESR module shared the same generic user interfaces and data processing functions with other modules in the CTMS. These generic components include data editing, data retrieving, data reporting, dictionary-based automatic and interactive coding, event-driven and calendar-driven automatic email notifications, and user privilege management. This integrated ESR module was implemented in the Albumin in Acute Stroke (ALIAS) Trial-Part 1. A total of 397 serious adverse event reports were processed and 33 FDA MedWatch reports, 28 initial reports, and 5 follow-up reports were submitted to FDA and Health Canada using this system. Experiences and lessons learned from the development and implementation of this system are presented in this paper.
AB - An electronic safety reporting (ESR) module was developed and integrated into a home-grown web-based clinical trial management system (CTMS) to enhance the efficiency, completeness and consistency of reporting and reviewing serious adverse events, monitoring safety, and submitting safety reports to regulatory authorities for a large multicenter clinical trial. The architecture of this integrated module provided many advantages. First, the ESR module was developed based on a comprehensive procedure which incorporated both computer logic processing steps and human intervention steps in order to deal with the complex and unexpected situations where pre-programmed computer logic may fail. Second, safety and efficacy data were managed within the same relational database. Relevant data captured on efficacy case report forms, such as demographics, medical history, lab data and concomitant medications, were directly retrievable for MedWatch report composition without requiring redundant data entry. Finally, the ESR module shared the same generic user interfaces and data processing functions with other modules in the CTMS. These generic components include data editing, data retrieving, data reporting, dictionary-based automatic and interactive coding, event-driven and calendar-driven automatic email notifications, and user privilege management. This integrated ESR module was implemented in the Albumin in Acute Stroke (ALIAS) Trial-Part 1. A total of 397 serious adverse event reports were processed and 33 FDA MedWatch reports, 28 initial reports, and 5 follow-up reports were submitted to FDA and Health Canada using this system. Experiences and lessons learned from the development and implementation of this system are presented in this paper.
KW - Clinical trial management system
KW - Electronic safety reporting
KW - MedWatch
KW - System integration
KW - Web based
UR - http://www.scopus.com/inward/record.url?scp=77957949198&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=77957949198&partnerID=8YFLogxK
U2 - 10.1016/j.cct.2010.08.010
DO - 10.1016/j.cct.2010.08.010
M3 - Article
C2 - 20828636
AN - SCOPUS:77957949198
VL - 31
SP - 536
EP - 543
JO - Contemporary Clinical Trials
JF - Contemporary Clinical Trials
SN - 1551-7144
IS - 6
ER -