Table 1 Improvements resulted by the AERS implementation.
From: An adverse event capture and management system for cancer studies
# | Area of improvement | Estimated/actual improvement |
|---|---|---|
1 | Time spend for adverse event clarification between the clinical trial office staff and providers | Estimated 60% less inquiries to clinics for clarification |
2 | All ongoing AEs are being assessed every visit | The number of sponsor queries has decreased, which reduced the time needed to identify and complete missed and incomplete assessments. |
3 | Complete and accurate reporting of AEs | Staff spends less time to compile data from systems to complete needed attributes of an AE report. This allows more thorough and accurate reporting. |
4 | Timely reporting of AEs | As the complete and accurate AE report is easily available, the staff reports those in a timely manner as expected by the sponsors and regulatory bodies. |
5 | Complete reporting of the lab related AEs | Before AERS, the lab AE reporting was paper based with some potential missed lab-based AEs. Each lab AE had to be signed by the provider with proper association. After AERS, the research staff estimates that they are reporting 75% more lab-based AEs and providers just make the clinical significance determination and submit electronically. |
6 | Time saving and efficiency due to less number of queries. | We analyzed two studies and both of which have 10 subjects enrolled and the same investigational product, the time frame is from April 2008 to the present date. A) Study A that doesn't use AERS, had 106 queries out of which 73 were AE related (~69%). B) Study B that uses AERS, had 169 queries out of which 36 were AE related (27%) |