9/29/2020
During the current COVID-19 pandemic, it has become necessary for sponsors of clinical trials to rely on remote methods to access electronic health records and electronic source data. 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. Here is one such question.
Question: If remote monitoring of source documents or electronic health records is being done by the sponsors, what safeguards on sponsor's laptops should be mandatory to protect study participants?
Answer: The source data available to the sponsor must be the pertinent study participant data needed to "monitor" the trial. It does not mean that all that data must be reviewed, also known as 100 percent source data verification (SDV), as monitoring pertinent data based on risk analysis is the basis of risk-based monitoring. The investigator must meet all applicable rules for data monitoring and privacy/security. Documenting and maintaining pertinent source data in a way that meets the ALCOA+ quality documentation standards is a requirement of clinical trial investigators. This source data should be made available to sponsors in a way that meets the privacy/security standards that are applicable in the region/country. So why ask sites for more than you need, thus increasing both the burden and risk of a data breach?
Read the full article published in the Clinical Leader, “Safeguarding Participant Data During Risk-based Monitoring — Practical Considerations” co-authored by Sandra "SAM" Sather and Jennifer Lawyer, to learn more.
You may also enjoy our related 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
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