This data model allows you to exchange data with any Clinical Management Systems (CTMS). The CTMS defines a clinical trial in their system and pushes data to the EHR system. Either you or your connection may enroll patients in the trial and share relevant information with between systems.
The Research data model is useful if you work with academia or strong research programs and are interested in patient study status or a list of active studies. You can exchange data if your organization does labs, imaging, or other work to contribute to the study. Your connections must have robust interfacing capabilities to use this data model.
This data model has event types that allow you to:
- receive a notification when a study is created or updated; or
- receive or push a notification about study participants.
Receive a notification when a new study is created or an existing study is updated in the CTMS. This event has information about one specific study.
Request Body Schema
- Metarequired, object
- DataModelrequired, stringReliable
Research
- EventTyperequired, stringReliable
Study
- EventDateTimestring, nullReliable
Displays the UTC date and time that an outgoing request is delivered or an incoming request is received.
ISO 8601 Format - Testboolean, nullReliable
Indicates whether the request is a test or not.
- Sourceobject
Contains the information for the system initiating the message, including the source ID and name.
Included in messages from Redox- IDstring, nullReliable
Identifies the system initiating the message. If you have multiple OAuth API keys per environment type, this value is required. If you have only one OAuth API key per environment type, or you're using legacy API keys, this value is optional.
UUID - Namestring, nullReliable
Displays the name of the system initiating the message.
- DestinationsArray of object
Contains the information for the endpoint(s) receiving the request. A request must contain at least one destination, but asynchronous requests can have more than one destination. Synchronous requests like queries can only support one destination.
Required when sending data to Redox.- IDstring, nullReliable
Identifies the endpoint that the request is directed to.
UUID - Namestring, nullReliable
Displays the name of the endpoint that the request is directed to.
- LogsArray of object
Contains the log identifier(s) for the request.
- IDstring, nullReliable
Identifies the request log(s) that correspond to this request. You can use this value to locate the relevant log in the Redox dashboard for support and reference.
UUID - AttemptIDstring, nullReliable
Identifies the request log attempt value, which is useful when retries are possible.
UUID
- FacilityCodestring, nullPossible
Code for the facility related to the message.
Only use this field if a health system indicates you should. The code is specific to the health system's EHR and might not be unique across health systems. In general, the facility fields within the data models (e.g. OrderingFacility) are more reliable and informative.
- Studyobject
- IdentifiersArray of object
Identifiers for the study. Should include both internal and external identifiers (such as an NCT ID)
- IDstring, nullReliable
- IDTypestring, nullReliable
- Titlestring, nullReliable
Official title of the study
- Typestring, nullReliableValue Set
The nature of the investigation or investigational use for the study.
- Sponsorobject
The sponsor of the study
- IDstring, nullProbable
Identifier for the sponsor of the study, if applicable
- Namestring, nullReliable
String representation of the sponsor name
- PrincipalInvestigatorobject
- IDstring, nullPossible
ID of the provider.
This ID is often required for Inpatient Visits. - IDTypestring, nullPossible
ID type of the ID for the provider
- FirstNamestring, nullPossible
First name of the provider
- LastNamestring, nullPossible
Last name of the provider
- CredentialsArray of string
List of credentials for the provider.
e.g. MD, PhD - Addressobject
Provider's address
- StreetAddressstring, nullPossible
Street address
- Citystring, nullPossible
City
- Statestring, nullPossible
State
- ZIPstring, nullPossible
ZIP
- Countystring, nullPossible
County
- Countrystring, nullPossibleValue Set
Country
- EmailAddressesArray of string
Provider's email address(es)
- PhoneNumberobject
- Officestring, nullPossible
Provider's office phone number.
In E. 164 Format. (e.g. +16085551234)
- Locationobject
Provider's location
- Typestring, nullPossible
Type of location.
Examples: Clinic, Department, Home, Nursing Unit, Provider's Office, Phone - Facilitystring, nullPossible
Facility.
Example: Community Hospital - FacilityIdentifiersArray of object
List of IDs specific to this facility
- IDstring, nullPossible
An ID specific to this facility
- IDTypestring, nullPossible
The source or system to which this ID pertains.
Could be an OID or a human-readable name
- Departmentstring, nullPossible
Department
- DepartmentIdentifiersArray of object
List of IDs specific to this department
- IDstring, nullPossible
An ID specific to this department
- IDTypestring, nullPossible
The source or system to which this ID pertains.
Could be an OID or a human-readable name
- Roomstring, nullPossible
Room.
Example: 136
- CoordinatorsArray of object
- IDstring, nullPossible
ID of the provider.
This ID is often required for Inpatient Visits. - IDTypestring, nullPossible
ID type of the ID for the provider
- FirstNamestring, nullPossible
First name of the undefined
- LastNamestring, nullPossible
Last name of the undefined
- CredentialsArray of string
List of credentials for the undefined.
e.g. MD, PhD - Addressobject
Provider's address
- StreetAddressstring, nullPossible
Street address
- Citystring, nullPossible
City
- Statestring, nullPossible
State
- ZIPstring, nullPossible
ZIP
- Countystring, nullPossible
County
- Countrystring, nullPossibleValue Set
Country
- EmailAddressesArray of string
Provider's email address(es)
- PhoneNumberobject
- Officestring, nullPossible
Provider's office phone number.
In E. 164 Format. (e.g. +16085551234)
- Locationobject
Provider's location
- Typestring, nullPossible
Type of location.
Examples: Clinic, Department, Home, Nursing Unit, Provider's Office, Phone - Facilitystring, nullPossible
Facility.
Example: Community Hospital - FacilityIdentifiersArray of object
List of IDs specific to this facility
- IDstring, nullPossible
An ID specific to this facility
- IDTypestring, nullPossible
The source or system to which this ID pertains.
Could be an OID or a human-readable name
- Departmentstring, nullPossible
Department
- DepartmentIdentifiersArray of object
List of IDs specific to this department
- IDstring, nullPossible
An ID specific to this department
- IDTypestring, nullPossible
The source or system to which this ID pertains.
Could be an OID or a human-readable name
- Roomstring, nullPossible
Room.
Example: 136
- Descriptionstring, nullProbable
Full description of the study
- Statusstring, nullProbable
What state the study is currently in. Drawn from the clinicaltrials.gov "Overall Recruitment Statuses".
Not yet recruiting: Participants are not yet being recruited Recruiting: Participants are currently being recruited, whether or not any participants have yet been enrolled Enrolling by invitation: Participants are being (or will be) selected from a predetermined population Active, not recruiting: Study is continuing, meaning participants are receiving an intervention or being examined, but new participants are not currently being recruited or enrolled Completed: The study has concluded normally; participants are no longer receiving an intervention or being examined (that is, last participant’s last visit has occurred) Suspended: Study halted prematurely but potentially will resume Terminated: Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention Withdrawn: Study halted prematurely, prior to enrollment of first participant - StartDateTimestring, nullProbable
The estimated date on which the clinical study will be open for recruitment of participants.
- ConditionsArray of object
- Codestring, nullProbable
A code describing conditions applicable to the study
- CodeSystemstring, nullProbable
ID of the coding system to which the code belongs in OID format.
Either CodeSystem or CodeSystemName (preferred) is required when a Code is present. - CodeSystemNamestring, nullProbable
Coding system to which the code belongs (e.g. SNOMED CT, LOINC, RxNorm, CVX, ICD9, ICD10).
Either CodeSystem or CodeSystemName (preferred) is required when a Code is present. - Namestring, nullProbable
Name of conditions applicable to the study
- AltCodesArray of object
Alternate or translation codes for conditions applicable to the study
- Codestring, nullPossible
A code describing conditions applicable to the study
- CodeSystemstring, nullPossible
ID of the coding system to which the code belongs in OID format.
Either CodeSystem or CodeSystemName (preferred) is required when a Code is present. - CodeSystemNamestring, nullPossible
Coding system to which the code belongs (e.g. SNOMED CT, LOINC, RxNorm, CVX, ICD9, ICD10).
Either CodeSystem or CodeSystemName (preferred) is required when a Code is present. - Namestring, nullPossible
Name of conditions applicable to the study
- Designobject
Information about how the trial will run.
- Purposestring, nullProbable
The objective of the study.
Treatment: One or more interventions are being evaluated for treating a disease, syndrome, or condition. Prevention: One or more interventions are being assessed for preventing the development of a specific disease or health condition. Diagnostic: One or more interventions are being evaluated for identifying a disease or health condition. Supportive Care: One or more interventions are evaluated for maximizing comfort, minimizing side effects, or mitigating against a decline in the participant's health or function. Screening: One or more interventions are assessed or examined for identifying a condition, or risk factors for a condition, in people who are not yet known to have the condition or risk factor. Health Services Research: One or more interventions for evaluating the delivery, processes, management, organization, or financing of healthcare. Basic Science: One or more interventions for examining the basic mechanism of action (for example, physiology or biomechanics of an intervention). Device Feasibility: An intervention of a device product is being evaluated in a small clinical trial (generally fewer than 10 participants) to determine the feasibility of the product; or a clinical trial to test a prototype device for feasibility and not health outcomes. Such studies are conducted to confirm the design and operating specifications of a device before beginning a full clinical trial. Other: None of the other options applies. - Phasestring, nullProbable
For studies of drug products, the numerical phase of the study.
N/A: Trials without phases (for example, studies of devices or behavioral interventions). Early Phase 1 (Formerly listed as "Phase 0"): Exploratory trials, involving very limited human exposure, with no therapeutic or diagnostic intent (e.g., screening studies, microdose studies). See FDA guidance on exploratory IND studies for more information. Phase 1: Includes initial studies to determine the metabolism and pharmacologic actions of drugs in humans, the side effects associated with increasing doses, and to gain early evidence of effectiveness; may include healthy participants and/or patients. Phase 1/Phase 2: Trials that are a combination of phases 1 and 2. Phase 2: Includes controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in participants with the disease or condition under study and to determine the common short-term side effects and risks. Phase 2/Phase 3: Trials that are a combination of phases 2 and 3. Phase 3: Includes trials conducted after preliminary evidence suggesting effectiveness of the drug has been obtained, and are intended to gather additional information to evaluate the overall benefit-risk relationship of the drug. Phase 4: Studies of FDA-approved drugs to delineate additional information including the drug's risks, benefits, and optimal use.
- Eligibilityobject
Rules about individuals eligible to participate in the study.
- Genderstring, nullProbable
The gender of the participants eligible to participate in the clinical study.
All, Male, or Female - MinimumAgenumber, nullProbable
Minimum age a potential participant must meet to be eligible for the clinical study.
- MaximumAgenumber, nullProbable
Maximum age a potential participant must meet to be eligible for the clinical study.
- Locationobject
- Typestring, nullProbable
Type of location.
Examples: Clinic, Department, Home, Nursing Unit, Provider's Office, Phone - Facilitystring, nullProbable
Facility.
Example: Community Hospital - FacilityIdentifiersArray of object
List of IDs specific to this facility
- IDstring, nullProbable
An ID specific to this facility
- IDTypestring, nullProbable
The source or system to which this ID pertains.
Could be an OID or a human-readable name
- Departmentstring, nullProbable
Department
- DepartmentIdentifiersArray of object
List of IDs specific to this department
- IDstring, nullProbable
An ID specific to this department
- IDTypestring, nullProbable
The source or system to which this ID pertains.
Could be an OID or a human-readable name
- Roomstring, nullProbable
Room.
Example: 136 - Addressobject
Physical address
- StreetAddressstring, nullProbable
Street address
- Citystring, nullProbable
City
- Statestring, nullProbable
State
- ZIPstring, nullProbable
ZIP
- Countystring, nullPossible
County
- Countrystring, nullPossibleValue Set
Country
- ProtocolsArray of object
Each protocol represents a sequence of events that will be assigned to a group of patients participating in the study.
- IDstring, nullPossible
The identifier for the protocol.
- IDTypestring, nullPossible
The identifier type for the protocol.
- Descriptionstring, nullPossible
The unique name for the protocol.
- CyclesArray of object
Each cycle represents a grouping of days within the protocol.
- IDstring, nullPossible
The identifier for the cycle.
- IDTypestring, nullPossible
The identifier type for the cycle.
- Descriptionstring, nullPossible
The unique name for the cycle.
- StartDatestring, nullPossible
The date the cycle begins.
ISO 8601 Format - EndDatestring, nullPossible
The date the cycle ends.
ISO 8601 Format - DaysArray of object
Each day represents a patient's visit related to the study protocol.
- IDstring, nullPossible
The identifier for this day.
- IDTypestring, nullPossible
The identifier type for the day.
- Descriptionstring, nullPossible
The unique name for the day.
- ActivityDateTimestring, nullPossible
The activity date.
ISO 8601 Format - EarliestDateTimestring, nullPossible
The earliest date in which the activity can be scheduled.
ISO 8601 Format - LatestDateTimestring, nullPossible
The latest date in which the activity can be scheduled.
ISO 8601 Format - ProceduresArray of object
A list of procedures that are related to the study day.
- Codestring, nullProbable
The identifier for the procedure.
- CodeSetstring, nullPossible
Identifiers for the protocol this patient should be enrolled in.
- Descriptionstring, nullPossible
The description of the procedure.
- ModifiersArray of string
List of modifiers for this procedure