What is the term used for built-in management controls within a research study?

The term "inherent controls" refers to the built-in management controls within a research study. These controls are fundamental aspects of the study design intended to manage risk and ensure ethical compliance without the need for additional external measures. They are integrated into the research process from the outset and are essential for maintaining integrity, safety, and validity within the research environment.

Inherent controls help researchers proactively address potential issues such as data integrity, participant safety, and adherence to ethical guidelines. By being incorporated directly into the study's framework, they work to prevent problems before they occur, rather than addressing them reactively.

The other terms, while related to control and oversight in research, do not specifically refer to these built-in mechanisms. Administrative controls often refer to policies and practices that guide overall governance of research activities, operational safeguards generally relate to procedures or measures enacted to protect data and participants in a broader context, and regulatory frameworks define the external legal and ethical standards that researchers must follow. In contrast, inherent controls are specifically designed into the research study itself, making them unique to the foundational structure of the research.