Prevention = Safety: No Tears Approach to Research Compliance - 2024

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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.

DISCLOSURE OF RELATIONSHIPS AND DECLARATIONS: CNE AND CME ACCREDITED SOCRA PROGRAMS

SOCRA adheres to the ACCME’s & ANCC’s Standards for Integrity and Independence in Accredited Continuing Education. Any individuals in a position to control the content of a CE activity, including faculty, planners, reviewers or others are required to disclose all relevant financial relationships with ineligible entities (commercial interests). All relevant conflicts of interest have been mitigated prior to the commencement of the activity.

SOCRA program content addresses regulatory issues and clinical research policies and procedures, no commercial therapies are discussed, no commercial (drug/device/biologic) products are discussed, and no commercial support is involved with SOCRA programs.

Planners and Speakers for programs have no undisclosed commercial relationships.

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