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.

A short, descriptive user-friendly label for the study.

The set of steps expected to be performed as part of the execution of the study.

A larger research study of which this particular study is a component or step.

Allows breaking a study into components (e.g. by study site) each with their own PI, status, enrollment, etc.

The current state of the study.

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

The type of study based upon the intent of the study's activities. A classification of the intent of the study.

The stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation.

Codes categorizing the type of study such as investigational vs. observational, type of blinding, type of randomization, safety vs. efficacy, etc.

The medication(s), food(s), therapy(ies), device(s) or other concerns or interventions that the study is seeking to gain more information about.

The condition that is the focus of the study. For example, In a study to examine risk factors for Lupus, might have as an inclusion criterion "healthy volunteer", but the target condition code would be a Lupus SNOMED code.

Contact details to assist a user in learning more about or engaging with the study.

Citations, references and other related documents.

Key terms to aid in searching for or filtering the study.

Indicates a country, state or other region where the study is taking place.

A full description of how the study is being conducted.

Reference to a Group that defines the criteria for and quantity of subjects participating in the study. E.g. " 200 female Europeans between the ages of 20 and 45 with early onset diabetes".

The Group referenced should not generally enumerate specific subjects. Subjects will be linked to the study using the ResearchSubject resource.

Identifies the start date and the expected (or actual, depending on status) end date for the study.

An organization that initiates the investigation and is legally responsible for the study.

A researcher in a study who oversees multiple aspects of the study, such as concept development, protocol writing, protocol submission for IRB approval, participant recruitment, informed consent, data collection, analysis, interpretation and presentation.

A facility in which study activities are conducted.

A description and/or code explaining the premature termination of the study.

Comments made about the study by the performer, subject or other participants.

Describes an expected sequence of events for one of the participants of a study. E.g. Exposure to drug A, wash-out, exposure to drug B, wash-out, follow-up.

Unique, human-readable label for this arm of the study.

Categorization of study arm, e.g. experimental, active comparator, placebo comparater.

A succinct description of the path through the study that would be followed by a subject adhering to this arm.

A goal that the study is aiming to achieve in terms of a scientific question to be answered by the analysis of data collected during the study.

Unique, human-readable label for this objective of the study.

The kind of study objective.