Quality Improvement & Monitoring

Quality Improvement & Monitoring

The aim of the internal quality monitoring program is to provide assistance for investigators and study staff to ensure that their study is in compliance with federal and state regulatory requirements and KP policies.

The process is intended as a mechanism for sharing best practices and to foster a culture of mutual respect between members of the Research Compliance Team and the research community.

Tools for GCP Compliance in Social and Behavioral Research

The definition of clinical trials was revised by the NIH in September 2016, expanded to include Social/Behavioral Research. “A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or control) to evaluate the effects of those intervention on health-related biomedical or behavioral outcomes.”

ICH-GCP is the international gold standard for clinical trials. These are not regulations but best practice guidance. We are expecting more social/behavioral research will be required to follow GCP and many researchers in this area are not familiar with the requirements.

Research Compliance created a work group in 2017 to create materials for social/behavioral research that can help study teams navigate the requirements. The Protocol Deviation Log and Delegation and Training Log templates can be found on our Forms & Templates page.

Investigator Guidance:  GCP Compliance for Social-Behavioral Research