IRB Data Formats Overview

IRB applications which communicate using the IRB Exchange need to share a common language to successfully transfer data between systems. This integration language consists of two major parts; the message structure (schema), and the hierarchy of the messages within the exchange (layout).

Schema

The IRB application model defines eight primary message types that need to be supported to enable integration across the exchange. Each message type is linked to another document which describes the structure of the message. Each primary message type also defines a header which contains enough information to parse the item content and present a small amount of information that can be used to identity the message.

Primary Types

• Document
• Principal Investigator
• Reportable New Information
• Reportable New Information Action Plan
• Site
• Site Continuing Review
• Site Modification
• Site sIRB Review Dates
• Study

Supporting Types

In addition to the primary message types, the IRB application model defines a few supporting types that are referenced within the schemas of the primary messages.

• Device
• Drug
• Funding Source
• Investigational Device Exemption
• Investigational New Drug
• Person
• sIRB Site Modification Info
• sIRB RNI Info

Headers

Each primary message item that is stored within the IRB Exchange consists of two parts; the header and the content. Each header will at a minimum define the following structure, but may include additional information specific to the message type.

Name	Type	Description
type	string	The type is the primary indicator for the structure of the information defined in the content
version	string	The version is the secondary indicator for the structure of the information defined in the content

Format

Each of the structured messages, except Document, are defined using the JSON format.

Layout

Each of the message types has a specific location where it should be stored within the IRB Exchange. Each location is relative to the items endpoint and the item related api methods should be used to manage these IRB application messages.

The base URL for the items endpoint is https://api.huronirbexchange.com/containers/{containerId}/items. Where the {containerId} is a unique identifier assigned to each multi-site study that is managed within the IRB Exchange.

/documents

This path stores a collection of Document messages, each represents a file that is associated to one of the other primary message types. Each document can be individually referenced using the following path template: /documents/{documentId}. The document id is typically a globally unique identifier (Guid).

/rni

This path stores a collection of Reportable New Information messages. Each represents an RNI that has been submitted to the single IRB of record by one of the participating sites.

/rni/{rniId}/action-plan

This path stores the action plan for an RNI.

/sites

This path stores a collection of Site messages, each representing an individual organization that is collaborating on the multi-site study. Each site record can be individually referenced using the following path template: /sites/{organizationId}. Where the organizationId is the exchange assigned identifier for the specific organization.

/sites/{organizationId}/continuing-review

This path stores a single Site Continuing Review message specific to an individual collaborating site.

/sites/{organizationId}/pi

This path stores the Principal Investigator for the participating site. Where the organizationId is the exchange assigned identifier for the specific participating site organization.

/sites/{organizationId}/modifications

This path stores a collection of Site Modification messages specific to an individual collaborating site which is indicated by the site's unique organization id. Each collaborating site has a collection of modifications. Each modification will have its own exchange assigned unique identifier, which allows the individual site modification message to be referenced via the following path template: /sites/{organizationId}/modifications/{modificationId}.

/sites/{organizationId}/review-dates

This path stores the sIRB review dates for a site.

/study

This path stores the study information.

/sites/{organizationId}/modifications/{modificationId}/sirb-site-modification-info

This path stores sIRB site modification info.

/rni/{rniId}/sirb-rni

This path stores sIRB RNI info.