A process where a researcher or organization plans and then executes a series of steps intended to increase the field of healthcare-related knowledge. This includes studies of safety, efficacy, comparative effectiveness and other information about medications, devices, therapies and other interventional and investigative techniques. A ResearchStudy involves the gathering of information about human or animal subjects.

Need to make sure we encompass public health studies.

Identifiers assigned to this research study by the sponsor or other systems.

Allows identification of the research study as it is known by various participating systems and in a way that remains consistent across servers.

The current state of the subject.

This element is labeled as a modifier because the status contains codes that mark the resource as not currently valid.

The dates the subject began and ended their participation in the study.

Reference to the study the subject is participating in.

The record of the person or animal who is involved in the study.

The name of the arm in the study the subject is expected to follow as part of this study.

The name of the arm in the study the subject actually followed as part of this study.

A record of the patient's informed agreement to participate in the study.