ARTICLES BY SANDRA "SAM" SATHER AND JENNIFER LAWYER
An ISO 14155:2020 Primer — Good Clinical Practice For Medical Device Trials2/2/2021
An analysis of the recently released ISO 14155:2020, "Clinical investigation of medical devices for human subjects — Good clinical practice," a standard developed to guide clinical research professionals during the design, conduct, recording, and reporting of clinical trials related to the safety and effectiveness of medical devices.
Safeguarding Participant Data During Risk-based Monitoring — Practical Considerations9/22/2020
With risk-based monitoring becoming more common, and with sponsor/CRO monitors reviewing electronic source data remotely, many questions have arisen regarding what security measures need to be in place to ensure the protection of study participants’ data.
Remote Monitoring In The Wake Of COVID-19 — Practical & Regulatory Considerations6/30/2020
In the long term, as we move into the reopening phases of COVID-19, faced with increased expenses and the challenges with on-site monitoring, clinical research professionals need to ensure their quality management systems have the flexibility for the new normal for site management.
Clinical Trial Root Cause Analysis: Can’t We Do Better Than Five Whys?1/15/2020
Root cause analysis should be a chance to take a step back and try to understand why an issue occurred, and to think critically, understand the process, and determine how the issue came about. The Five Whys approach can lead us to a simple “root cause” and action, but does it enable us to really understand the issue?