RNI Action Plan

RNI Action Plan is set on an RNI through review on the sIRB side. It is downloaded onto the RNI on the pSite side in order to garner an action response back.

Header

Name	Type	Description
type	string	The value reportable-new-information-action-plan
version	string	The value IRBX.2.

Content

Name	Type	Description
description	string	The action plan description
determinationIds	Array of string	The determinations given the RNI by sIRB review
responsibleParty	Person	The Person selected as responsible party

Determination IDs Selection Values

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

ID	Description
ADDITIONAL_INFO	Additional information required before making a determination
UNANTICIPATED	Unanticipated problem involving risks to subjects or others
SUS_OR_TERM	Suspension or termination of IRB approval
SERIOUS	Serious non-compliance
CONTINUING	Continuing non-compliance
NONCOMPLIANCE	Non-compliance that is neither serious nor continuing
ALLEGATION	Allegation of non-compliance with no basis in fact
NONE	None of the above
ADDITIONAL_REVIEW	Additional review required
PSITE_REVIEW	Route for pSite review
LOCAL_REVIEW_VIA_SIRB	sIRB recommends local IRB review

Example

{
    "type": "reportable-new-information-action-plan",
    "version": "IRBX.2"
}

{
    "description": "The consent forms need to more clearly state the risk",
    "determinationIds": [
        "CONTINUING",
        "UNANTICIPATED"
    ]
    "responsibleParty": { 
        "firstName": "Jack",
        "lastName": "Smith",
        "email": "testuser@huronclick.com",
        "id": "uuid:6934774a3ff74619a51322fafc8b1fce"
    }
}