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Thomas Jefferson University

Jefferson Surgical Solutions

Journal

2016

Complex Trials

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Changing Lives Through Research: Clinical Research Team Supports Over 100 Diverse, Complex Trials May 2016

Changing Lives Through Research: Clinical Research Team Supports Over 100 Diverse, Complex Trials

Jefferson Surgical Solutions

Faculty in the Department of Surgery are currently leading or participating in more than 100 clinical trials. Each has a distinct protocol and requires management of numerous components – from patient recruitment and informed consent to electronic data entry and management of subject care throughout the trial. All of these activities must comply with regulations imposed by the Food & Drug Administration (FDA), National Institute of Health (NIH) Collaborative Institutional Training Initiative (CITI) and Health Insurance Portability and Accountability Act (HIPAA), which require the protection of Personal Health Information.

To navigate those complexities, the Department relies on the Clinical Research …