Effective monitoring for a medical device trial

While procedures, checklists, guidance documents, report templates and all sorts of other things combine to form the infrastructure for monitoring, what is possibly even more important is the shared mindset.  The acceptance by all that regardless of the title, there is a shared responsibility in calling out issues, in looking purposefully at this document, in questioning that blank.
The purpose of clinical trial monitoring can be summed up as follows:

To ensure protection of the rights and well-being of study subjects
To ensure date integrity
To ensure compliance with federal regulations, agreements, clinical investigational plan and the requirements of the IRB
To identify and address non-compliance
To improve quality and promote high standards
To identify research misconduct and fraud

The empowerment of others to assume the role of monitor every day they come to work in whatever capacity that is, will achieve the desired goals – protected patients, compliance, and quality.  To monitor is more than a title. It is a mindset.
Please take time to download IMARC Research’s whitepaper on developing a monitoring mindset.  How has your organization developed a monitoring mindset? Share your thoughts below.
The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.
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Source: Mass Device - June 12, 2018 Category: Medical Devices Authors: Danielle Kirsh Tags: Blog IMARC Source Type: news