7/07/2020

Have you ever heard or stated, “We are not doing risk-based monitoring for this study”? This is using the term to refer to a style vs. a process to conduct monitoring based on risk. This means that there was a decision to conduct “traditional” monitoring, with 100 percent source data verification (SDV) and/or 100 percent data review of trial subjects. But regulatory agencies, including the FDA, require sponsors to monitor the quality of their clinical investigations, and ICH E6(R2) made it clear that this includes ensuring that monitoring is based on risk. During the COVID-19 pandemic, clinical research sites have reduced the number of staff on-site and restricted on-site monitoring. Travel restrictions and the safety of the sponsor or CRO monitors also compound the challenges of monitoring on-site. This revealed a significant barrier to the ability to quickly shift to remote monitoring in the short term, due to the lack of agility of the quality systems to respond to change based on risk.

Read more in the Clinical Leader article, “Remote Monitoring In The Wake Of COVID-19 — Practical & Regulatory Considerations,” co-authored by Sandra "SAM" Sather and Jennifer Lawyer.

You may be interested in our related recorded webinars:

1. ‘Remote Monitoring Operations and Maintaining HIPAA, GCP, and COVID-19 Restrictions’ including a helpful Q&A reference free with purchase.

The focus is on the sponsor/CRO’s perspective. Purchase by clicking here.

2. ‘A Case for Sponsor Monitoring Remote Access to a Site’s EMR!’

The focus is on the site’s perspective. Purchase by clicking here.

Clinical Pathways also offers a variety of GCP eLearning courses for individual training or as enterprise solutions. We can use your content to create new trainings for in-person, web-based, or eLearning formats to meet your company's training needs. We can also update our off-the-shelf courses to include your processes, SOPs, and branding.

Want a faster and more affordable option? Clinical Pathways offers convenient course bundles of off-the-shelf eLearning at a discounted rate. Visit our store by clicking HERE to learn more or to view interactive demos.

- The Clinical Pathways Team

Enjoy this blog? Please like, comment, and share with your contacts.