Site Modification

Modification for a Site as uploaded from the pSite side.

Header

Name	Type	Description
type	string	The value site-modification
version	string	The value IRBX.2.

Content

Name	Type	Description
dateCreated	date	The date the site modification was created
draftSite	Site	The draft site that stores a copy of the site changes for the modification
enrollmentStatus	Array of string	Selected statements about the site enrollment status
status	string	The state of the site modification
subjectNotifications	Array of string	Selected statements about how subjects will be notified of changes
summary	string	Summary of the modificiation

Enrollment Status Selection Values

The following table shows the selections supported by the IRB Exchange for site modification enrollment status.

ID	Description
NONE_ENROLLED	No subjects have been enrolled to date
CURRENT_ENROLLED	Subjects are currently enrolled
ENROLLMENT_CLOSED	Study is permanently closed to enrollment
INTERVENTIONS_COMPLETED	All subjects have completed all study-related interventions
INFO_COLLECTION_COMPLETE	Collection of private identifiable information is complete

Subject Notifications Selection Values

The following table shows the selections supported by the IRB Exchange for site modification subject notification.

ID	Description
CURRENT_SUBJECTS	Current subjects will be notified of these changes
FORMER_SUBJECTS	Former subjects will be notified of these changes

Example

{
    "type": "site-modification",
    "version": "IRBX.2"
}

{
    "dateCreated": "8/23/2017 7:04:02 PM +00:00",
    "draftSite": {
        "attachments": [
            {
                "attachmentId": "documents/47086805f7dc4966b4a0c8736b7e32c4",
                "category": "Other",
                "draftDateModified": "8/23/2017 7:04:02 PM +00:00",
                "draftFileName": "Test.txt",
                "draftId": "documents/47086805f7dc4966b4a0c8736b7e32c4/draft",
                "draftInitialSiteId": "documents/65486805f7dc4966b4a0c8736b7e34t5/draft",
                "draftName": "Test.txt",
                "draftVersion": "0.01",
                "finalDateModified": "8/23/2017 7:53:06 PM +00:00",
                "finalFileName": "Test.pdf",
                "finalId": "documents/47086805f7dc4966b4a0c8736b7e32c4/final",
                "finalInitialSiteId": "documents/65486805f7dc4966b4a0c8736b7e34t5/final",
                "finalName": "Test.pdf",
                "finalVersion": "0.01"
            }
        ],
        "consentForms": [
            {
                "attachmentId": "documents/47086805f7dc4966b4a0c8736b7e32c4",
                "category": "Consent Form",
                "draftDateModified": "8/23/2017 7:04:02 PM +00:00",
                "draftFileName": "Test.txt",
                "draftId": "documents/47086805f7dc4966b4a0c8736b7e32c4/draft",
                "draftInitialSiteId": "documents/65486805f7dc4966b4a0c8736b7e34t5/draft",
                "draftName": "Test.txt",
                "draftVersion": "0.01",
                "finalDateModified": "8/23/2017 7:53:06 PM +00:00",
                "finalFileName": "Test.pdf",
                "finalId": "documents/47086805f7dc4966b4a0c8736b7e32c4/final",
                "finalInitialSiteId": "documents/65486805f7dc4966b4a0c8736b7e34t5/final",
                "finalName": "Test.pdf",
                "finalVersion": "0.01"
            }
        ],
        "description": "Description for the site",
        "fundingSources": [
            {
                "id": "uuid:cde50874360c4dc0a0a8a7d1ee8986ed",
                "name": "Abbott Laboratories",
                "sponsorId": "1001",
                "grantsOfficeId": "2001",
                "documents": [
                    {
                        "attachmentId": "documents/47086805f7dc4966b4a0c8736b7e32c4",
                        "category": "Funding Source Attachment",
                        "draftDateModified": "8/23/2017 7:04:02 PM +00:00",
                        "draftFileName": "Test.txt",
                        "draftId": "documents/47086805f7dc4966b4a0c8736b7e32c4/draft",
                        "draftInitialSiteId": "documents/65486805f7dc4966b4a0c8736b7e34t5/draft",
                        "draftName": "Test.txt",
                        "draftVersion": "0.01",
                        "finalDateModified": "8/23/2017 7:53:06 PM +00:00",
                        "finalFileName": "Test.pdf",
                        "finalId": "documents/47086805f7dc4966b4a0c8736b7e32c4/final",
                        "finalInitialSiteId": "documents/65486805f7dc4966b4a0c8736b7e34t5/final",
                        "finalName": "Test.pdf",
                        "finalVersion": "0.01"
                    }
                ]
            }
        ],
        "principalInvestigator": {
            "id": "nh4ff2cbadb74231ba059878820fdr34",
            "firstName": "Joan",
            "lastName": "Smith",
            "email": "joansmith@huronclick.com",
            "hasFinancialInterest": false
        },
        "recruitmentMaterials": [
            {
                "attachmentId": "documents/47086805f7dc4966b4a0c8736b7e32c4",
                "category": "Recruitment Materials",
                "draftDateModified": "8/23/2017 7:04:02 PM +00:00",
                "draftFileName": "Test.txt",
                "draftId": "documents/47086805f7dc4966b4a0c8736b7e32c4/draft",
                "draftInitialSiteId": "documents/65486805f7dc4966b4a0c8736b7e34t5/draft",
                "draftName": "Test.txt",
                "draftVersion": "0.01",
                "finalDateModified": "8/23/2017 7:53:06 PM +00:00",
                "finalFileName": "Test.pdf",
                "finalId": "documents/47086805f7dc4966b4a0c8736b7e32c4/final",
                "finalInitialSiteId": "documents/65486805f7dc4966b4a0c8736b7e34t5/final",
                "finalName": "Test.pdf",
                "finalVersion": "0.01"
            }
        ]
    },
    "enrollmentStatus": [
        "INTERVENTIONS_COMPLETED",
        "ENROLLMENT_CLOSED"
    ],
    "status": "Pending sIRB Review",
    "subjectNotifications": [
        "CURRENT_SUBJECTS",
        "FORMER_SUBJECTS"
    ],
    "summary": "We are modifying the consent forms to be clearer."
}