Prevention = Safety: No Tears Approach to Research Compliance
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The value of implementing preventive quality assurance measures is essential to ensuring research compliance. Significant findings during an inspection or audit can results in damaged reputations, loss of existing or future funding, and impact the confidence of the research team. For a research team to be successful, it is vital they proactively identify risks and implement measures to ensure patient safety and the integrity of the research. This proactive approach provides opportunities for coaching, mentoring, and training in a supportive non-punitive way. Preventive measures can provide confidence within the research team, preventing the crisis mode mentality that often precedes an audit or inspection.
OBJECTIVE: Understand the value of prevention and how to implement preventive measures.
Angie Price, MSN, CCRC
Project Director, Clinical Site Network
Institute for Advanced Clinical Trials for Children (I-ACT)
Angie is the Project Director, Clinical Site Network at -ACT for Children. She is overseeing the Children’s Pediatric Improvement collaborative for Clinical Trials & Research, otherwise known as PICTR®. Mrs. Price has over 30 years’ of clinical trials experience. She has been certified in clinical research since 1999. She holds a master’s degree in clinical research administration.