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 D.
AU - Hill, Michael D.
AU - Palesch, Yuko
N1 - Funding Information:
This work was supported by funding through the NIH grant ( U01 NS054630 ) and ( U01 NS40406 ) from the National Institute of Neurological Disorders and Stroke (NINDS). The findings reported here are those of the authors and do not necessarily represent the views of NINDS. The authors would like to thank Drs. Stephan Mayer (Columbia University), Andrew Naidech (North Western University), and Alejandro Rabinstein (Mayo Clinic) for acting as the Medical Safety Monitors and Dr. Diego Tamariz for acting as the Central Coder for the ALIAS- Part 1 Trial. The authors would also like to thank the following ALIAS Executive Committee members for their guidance through the course of the trial: Dr. Claudia Moy (National Institute of Neurological Disorders and Stroke), Dr. Renee Martin (Medical University of South Carolina), Dr. Sharon Yeatts (Medical University of South Carolina), Mr. Richard Leinster (Medical University of South Carolina), Ms. Karla Ryckborst (University of Calgary), and Ms. Isa Mendez (University of Miami). Finally, the authors would like to thank the ALIAS- Part 1 Clinical Investigators and subjects without whom this manuscript would not have been possible.
PY - 2010/11
Y1 - 2010/11
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
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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 -