Join Us at the Society of Quality Assurance Virtual Meeting Sep. 21-22

9/15/2020

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Sandra “SAM” Sather will be speaking at the Society of Quality Assurance (SQA) September Virtual Meeting and Quality College on the topics:

  1. Quality Risk Management Not an Option, But A Mindset, What Are We Learning During COVID-19

  2. Remote Operations and Maintaining HIPAA, GDPR, GCP, and COVID-19

When: September 21 and 22, 2020

Where: Virtual

Schedule: HERE

Register: HERE

Background:

1.    Quality Risk Management Not an Option, But A Mindset, What Are We Learning During COVID-19

The industry frequently misunderstands what is meant by risk-based monitoring (RBM) and risk-based quality management (RBQM). There is a misconception that clinical trials will either be done with RMB or traditional 100% source data verification (SDV) monitoring, when all trials need to have the approach of being based on risk. RBQM is appropriate for all trials regardless of the monitoring plan and is required based on ICH E6(R2). The decision is not whether RBQM will be done, but rather how the trial will be done based on RBQM. Join us to discuss the root cause and effective methods to create the mindset needed.

2.    Remote Operations and Maintaining HIPAA, GDPR, GCP, and COVID-19

The ongoing challenge of site closures, travel restrictions, and social distancing has many unsure of how to proceed even with the FDA guidance document for conducting clinical trials during the COVID-19 pandemic, the Office for Civil Rights’ (OCR) Notification of Enforcement Discretion on telehealth and HIPAA, European Medicines Agency’s (EMA) Guidance on the management of clinical trials during the covid-19 (coronavirus) pandemic, and OCR's frequently asked questions guidance. Remote monitoring of the quality of the original source data is feasible, although measures need to be taken to reduce risk to data security breach. This session ties in compliance with clinical trial predicate rules, including HIPAA, GCP, GDPR, and FDA, and guidances from EMA, OCR, and FDA. 

- The Clinical Pathways Team

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