BIMO Part 5b - Strategies For Clinical Investigators to Build Quality into Device Research
A clinical investigator's primary responsibilities are the protection of human subjects, supervising the conduct of the investigation, and ensuring the quality and integrity of the data. During this presentation, I will discuss various strategies to assist an investigator to build quality into device research. Some of these strategies include the concepts of: quality data, the data lifecycle, and quality studies; suggestions (what we refer to as helpful hints) for investigators to conduct Quality Studies; and a quality systems approach. Applying the strategies discussed in this presentation will assist an investigator to build quality into every step of device research.