Now Available FAQ Document and Recorded Webinar: “Remote Monitoring Operations While Maintaining HIPAA, GCP, and COVID-19 Restrictions”

4/07/2020

Our popular “Remote Monitoring Operations While Maintaining HIPAA, GCP, and COVID-19 Restrictions” webinar prompted many important questions, which we answered during the webinars. If you missed the webinar, a recording is now available for purchase. We also compiled a FAQ document to help guide your remote monitoring efforts during the crisis.

One example from the FAQ document is:

Q: If we wanted to use a cloud-based platform to remotely monitor source data in the U.S., does the information need to be redacted according to HIPAA?

A: If the HIPAA authorization, informed consent, and CTA are in place and support that the subject has given permission for the sponsor to use the data, and the data being requested are part of that pertinent study source, redaction is a burden and unnecessary. The exception is if the site has stricter institution practice requirements. Also, sometimes the study coordinator does not know the policies, especially during this crisis. The CTA should state how security and maintenance of privacy / confidentiality are maintained. Also, the ICF may need to be amended. Check the language carefully.

We are offering two ways to support you in navigating the new normal.

  1. Our webinar recording is now available for purchase. Access to the recording is available for 10 days after purchase. Purchase here.

  2. The webinar FAQ is available as a free companion document with the webinar recording for a limited time.

Learn how to work together with sites to review source in a risk-based regulatory environment while being mindful not to overburden sites or put data at risk of security breach.

The course presents:

  1. Myths of remote review of source data

  2. A simple process for working together as sponsor and site to ensure quality data without being at site

  3. How to overcome the barriers of quality data review

  4. The elements in a quality management system that need to be in place or updated at trial sites and sponsors to initiate this successfully for now and future crisis

  5. How to ensure audit readiness for all

- The Clinical Pathways Team

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