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 or stability data about drug products or drug substances.

Need to make sure we encompass public health studies.

Canonical identifier for this study resource, represented as a globally unique URI.

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.

Business identifier for the study record.

Name for this study (computer friendly).

A short, descriptive label for the study particularly for compouter use.

Additional names for the study.

Kind of name.

The name.

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.

Citations, references and other related documents.

Date the resource last changed.

The publication state of the resource (not of the study).

The type of study based upon the intent of the study 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.

Identification of product under study. This may be any combination of code and/or name.

Indicates whether the focus is a medication, a device, a procedure, a specific factor or some other intervention or characteristic.

A factor corresponds to an independent variable manipulated by the experimentalist with the intention to affect biological systems in a way that can be measured by an assay.

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.

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 brief summary of the study description.

A full description of how the study is being conducted. For a description of what the study objectives are see ResearchStudy.objective.description.

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

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

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

Classification for the study.

Type of classifier.

Value of classifier.

Sponsors, collaborators, and other parties.

While there are explicit attributes for a Sponsor and a PrincipalInvestigator many trial record a range of other organizations and individuals in key roles.

For a Sponsor or a PrincipalInvestigator use the dedicated attributes provided.

Name of associated party.

Type of association.

Organisational type of association.

Individual or organization associated with study (use practitionerRole to specify their organisation).

Suggestions of a better attribute name are appreciated

Current status of the study.

Status of study with time for that status.

Label for status or state.

Actual if true else anticipated.

Date range.

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

Target or actual group of participants enrolled in study.

Estimated total number of participants to be enrolled.

Actual total number of participants enrolled in study.

Inclusion and exclusion criteria.

Group of participants who were enrolled in study.

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.

In many clinical trials this is refered to as the ARM of the study, but such a term is not used in other sorts of trials even when there is a comparison between two or more groups.

Allows the comparisonGroup for the study and the comparisonGroup for the subject to be linked easily.

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

Categorization of study comparisonGroup, 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 comparisonGroup.

Interventions or exposures in this comparisonGroup or cohort.

this is necessary for ClinicalTrials.gov use which relates 1 to many interventions to comparisonGroups (aka arms)

Group of participants who were enrolled in study comparisonGroup.

This is necessary to relate comparisonGroups to actual groups

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.

Free text description of the objective of the study. This is what the study is trying to achieve rather than how it is going to achieve it (see ResearchStudy.description).

An outcome or planned variable to measure during the study.

Label for the outcome.

The parameter or characteristic being assessed as one of the values by which the study is assessed.

Description of the outcome.

Structured outcome definition.

Link to one or more sets of results generated by the study. Could also link to a research registry holding the results such as ClinicalTrials.gov.

A general storage or archive location for the study. This may contain an assortment of content which is not specified in advance.

Describes the nature of the location being specified.

The location address.