Monitors are grounded but the data needs to be monitored. This course discusses the real feasibility of remote monitoring of the quality of the original source data in compliance with clinical trial predicate rules, including HIPAA and FDA. This is not asking sites to be burdened with scanning and redacting documents or be put at risk for security breaches. The review of source in a risk-based regulatory environment is based on the quality of the documentation not the comparison of the source to the eCRF. This crisis is an opportunity to propel us further into really working risk-based and have the agility to keep trials moving even during this crisis.

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

Learning Objectives: 

• Clarify what data are accessible remotely from HIPAA covered entities

• Develop agreements between stakeholders to support remote source review

• Identify how to evaluate the feasibility of remote monitoring of the quality of site source data without threat of security breach

• Promote better remote monitoring practices and documentation Who Should Attend: This course will be of benefit to anyone responsible for clinical operations of those that monitor, audit and coordinate clinical trial subject source data.

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