November 2024 SOCRA Source Journal - Journal - Page 75
Acknowledgements
Abhik Das1, Lauren Bradley1, Katie Fain1, Matthew Foster1, Sophie Li1, Emily Smith1, Gene Turner1, Michelle
Schreiner2, Theresa O’Reilly2, Ann Lawrence Holmes2, Brian Smith2, Rachel Greenberg2, Candice Quick2,
Alexandra Kaminski2, Jessica Snowden3, Jeanette Lee3, Kathy Edwards3, Lori Devlin-Phinney4, Leslie Young5,
Abbot Laptook6, Adam Cyznski6, Erica Olivera6, Stephanie Merhar7, Cathy Grisby7, Andrew Bremer8, Stephanie
Archer8, Alan Simon8, Michelle Walsh8
1
2
3
4
5
6
7
8
RTI International
Duke Clinical Research Institute
University of Arkansas Medical Sciences
University of Louisville
University of Vernmont
Women and Infants Health Rhode Island
University of Cincinnati
National Institutes of Health
References
1 Bianchi DW and Gillman MW. Addressing the impact of opioids on women and children. American Journal
of Obstetrics and Gynecology 2019; 221: 123. e121-123. e124.
2 Waterhouse DM, Harvey RD, Hurley P, et al. Early Impact of COVID-19 on the Conduct of Oncology
Clinical Trials and Long-Term Opportunities for Transformation: Findings From an American Society of Clinical
Oncology Survey. JCO Oncology Practice 2020; 16: 417-421. DOI: 10.1200/op.20.00275.
3 Izmailova ES, Ellis R and Benko C. Remote Monitoring in Clinical Trials During the COVID-19 Pandemic.
Clinical and Translational Science 2020. DOI: 10.1111/cts.12834.
4 Williams EL, Pierre DL, Martin ME, et al. Taking Tele Behind the Scenes: Remote Clinical Trial Monitoring
Comes of Age During the COVID-19 Pandemic. JCO Oncology Practice 2021; 17: 577-579. DOI: 10.1200/
op.21.00524.
5 USDHHS. Oversight of Clinical Investigations - A Risk-Based Approach to Monitoring (Guidance for
Industry). In: FDA, (ed.). US DHHS FDA, 2013.
6 Uren SC, Kirkman MB, Dalton BS, et al. Reducing Clinical Trial Monitoring Resource Allocation and Costs
Through Remote Access to Electronic Medical Records. Journal of Oncology Practice 2013; 9: e13-e16. DOI:
10.1200/jop.2012.000666.
7 Florence Healthcare: The Ultimate Guide to eRegulatory for Clinical Trials. https://昀氀orencehc.com/pillarpage-eregulatory/ (2023, accessed July 2023 2023).
8 Yamada O, Chiu S-W, Takata M, et al. Clinical trial monitoring effectiveness: Remote risk-based monitoring
versus on-site monitoring with 100% source data veri昀椀cation. Clinical Trials 2021; 18: 158-167.
DOI: 10.1177/1740774520971254.
9 Fu Z, Liu X, Zhao S, et al. Reducing Clinical Trial Monitoring Resources and Costs With Remote Monitoring:
Retrospective Study Comparing On-Site Versus Hybrid Monitoring. Journal of Medical Internet Research
2023; 25: e42175. DOI: 10.2196/42175.
10 USDHHS. Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency:
Guidance for Industry, Investigators, and Institutional Review Boards. In: Services UDoHaH, (ed.). 2020.
SOCRA SOURCE © November 2024
75
