RNI

Reportable New Information represents a submission of type RNI. It is uploaded from the pSite side and the sIRB side downloads it to review, and possibly upload an RNI Action Plan and get an action response in updated RNI data.

Header

Name	Type	Description
name	string	The name of the RNI.
principalInvestigator	string	The full name of the principal investigator.
sitePrincipalInvestigator	string	The full name of the reporting site's principal investigator.
type	string	The value reportable-new-information
version	string	The value IRBX.2

Content

Name	Type	Description
actionResponseDocuments	Array of Document Reference	Documents forming part of the action plan response
actionResponseId	string	Unique identifier for each action response, assigned by the IRB Exchange
actionResponseNotes	string	Notes forming part of the action plan response
categories	Array of string	Selected categories for the RNI
dateOfAwareness	date	Date reported by user indicated when they became aware of the new information
description	string	Description of the RNI
isIncreasedRiskOrSafetyIssue	boolean	Flag indicating if the RNI is an increased risk or safety issue
name	string	Short title of the RNI
reportedBy	string	The Person who reported the RNI
requiresProtocolRevision	boolean	Flag indicating if the protocol of the related study requires revision
requiresConsentFormRevision	boolean	Flag indicating if the consent forms of the related study require revision
supportingDocuments	Array of Document Reference	Supporting documents related to the RNI

Categories Selection Values

The following table shows the selections supported by the IRB Exchange for reportable new information category.

ID	Description
RISK	Risk: Information that indicates a new or increased risk, or a safety issue.
HARM	Harm: Any harm experienced by a subject or other individual that, in the opinion of the investigator, is unexpected and at least probably related to the research procedures.
NON-COMPLIANCE	Non-compliance: Non-compliance with the federal regulations governing human research or with the requirements or determinations of the IRB, or an allegation of such non-compliance.
AUDIT	Audit: Audit, inspection, or inquiry by a federal agency.
REPORT	Report: Written reports of study monitors.
RESEARCHER-ERROR	Researcher error: Failure to follow the protocol due to the action or inaction of the investigator or research staff.
CONFIDENTIALITY	Confidentiality: Breach of confidentiality.
UNREVIEWED-CHANGE	Unreviewed change: Change to the protocol taken without prior IRB review to eliminate an apparent immediate hazard to a subject.
INCARCERATION	Incarceration: Incarceration of a subject in a study not approved by the IRB to involve prisoners.
SUBJECT-COMPLAINT	Complaint: Complaint of a subject that cannot be resolved by the research team.
SUSPENSION	Suspension: Premature suspension or termination of the research by the sponsor, investigator, or institution.
ADVERSE-DEVICE-EFFECT	Unanticipated adverse device effect: Any serious adverse effect on health or safety or any life-threatening problem or death caused by, or associated with, a device, if that effect, problem, or death was not previously identified in nature, severity, or degree of incidence in the investigational plan or application (including a supplementary plan or application), or any other unanticipated serious problem associated with a device that relates to the rights, safety, or welfare of subjects.
VA-SAE	VA-SAE: For Department of Veterans Affairs (VA) research, all local or internal serious adverse events (SAEs).

Example

{
    "name": "",
    "principalInvestigator": "",
    "type": "reportable-new-information",
    "version": "IRBX.2"
}

{
    "actionReponseDocuments": [
        {
            "draftDateModified": "8/23/2017 7:04:02 PM +00:00",
            "draftFileName": "Test.txt",
            "draftId": "documents/47086805f7dc4966b4a0c8736b7e32c4/draft",
            "draftName": "Test.txt",
            "draftVersion": "0.01"
        }
    ]
    "actionResponseId": "cb92d258d57d4f5bbc0df4d6d5ed6e28",
    "actionResponseNotes": "We made the risk statements clearer on the consent forms",
    "categories": [
        "RISK",
        "RESEARCHER-ERROR"
    ],
    "dateOfAwareness": "8/22/2017 9:42:35 AM +00:00",
    "description": "We had a complaint from a trial participant about the consent forms not being clear.",
    "isIncreasedRiskOrSafetyIssue": true,
    "name": "Consent Form Clarity Complaint",
    "reportedBy": "Jack Smith",
    "requiresProtocolRevision": true,
    "requiresConsentFormRevision": true,
    "supportingDocuments": [
        {
            "draftDateModified": "8/22/2017 9:42:35 AM +00:00",
            "draftFileName": "Test.txt",
            "draftId": "documents/47086805f7dc4966b4a0c8736b7e32c4/draft",
            "draftName": "Test.txt",
            "draftVersion": "0.01"
        }
    ]
}