The Future of Clinical Trials Using Electronic Data Capture Systems

Adam Donat, MS, Martin Hamilton, MSN-FNP, Irfan Khan, MS, Nichole Chamberlain, MSN-FNP

Organization:   Food and Drug Administration, Center for Devices and Radiological Health, Office of Compliance, Division of Bioresearch Monitoring

The findings and conclusions in this article should not be construed to represent any Agency determination or policy.

Technology continues to permeate every facet of the modernized world. As the medical field relies more and more on computerized technology, unique issues have emerged especially in the area of clinical trials and the use of Electronic Data Capture (EDC). Novel approaches to safeguard data integrity and human subjects need to be considered at every juncture of the research process.

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Informed Consent and the Human Experience

Cheryl B. Thomas, MS, CGC, Research Subjectinformed consent Advocate, Mayo Clinic

Abstract

Going “beyond the regulations” that govern informed consent and understanding the perspective of research participants is crucial to obtaining truly informed consent. This article describes the aspects of informed consent that involve human experience and interactions. Positive and negative feedback from research participants is reviewed to illustrate common issues in participation in clinical research. Participant suggestions for improving comprehension and the overall informed consent experience are shared.

Disclaimers: The author is sharing her own views based on conversations with many research participants. The federal regulations are not reviewed because many of the problems with informed consent arise even when the study team follows the regulations.

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