IRB Exchange

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Site sIRB Review Info

Review dates and determination for a Site as uploaded by the sIRB.

Header

Name Type Description
type string The value site-sirb-review-dates
version string The value IRBX.2.

Content

Name Type Description
approvalDate date The date the site was approved by the sIRB
correspondenceLetter Document Reference Final version of the site correspondence letter from the single IRB of record for the site.
determination string The name of the determination
effectiveDate date The last effective date the site was reviewed on
finalizedAttachments Array of Document Reference Other site documents finalized by single IRB of record site.
finalizedConsentForms Array of Document Reference Consent forms finalized by single IRB of record site.
finalizedRecruitmentMaterials Array of Document Reference Recruitment materials finalized by single IRB of record site.
finalizedSponsorAttachments Array of Document Reference Funding source attachments finalized by single IRB of record site.
initialEffectiveDate date The initial effective date the site was reviewed on
lastDayOfApproval date The last day of approval of the site
requiredModifications string Description of the modifications required to secure approval
sirbSiteStatus string ID of the current sIRB Site Status

Determination Selection Values

The following table shows the selections supported by the IRB Exchange for sIRB site determination.

Name
Approved
Deferred
Disapproved
Modifications Required to Secure "Approved"

Status Selection Values

The following table shows just the key status selections required by the IRB Exchange. This is not a complete list, but rather the selections that must match these exact values for the appropriate states. Huron recognizes that customers may have different status selection values than its own IRB solution; for non-key status selections, any unique string is acceptable. If any of your key status selections do not match the below values, you will need to map your status selections to the appropriate values below.

ID Description
Active The post-approval state after the sIRB site has been approved, correspondence letter sent and is ready for modifications.
Inactive The post-approval state after the sIRB has deactivated the sIRB site.
Closed The post-approval state after the sIRB has closed the sIRB site.
Suspended The post-approval state after the sIRB has suspended the sIRB site.
Terminated The post-approval state after the sIRB has terminated the sIRB site.

Example

{
    "type": "site-sirb-review-dates",
    "version": "IRBX.2"
}
{
    "approvalDate": "8/23/2017 7:00:00 AM +00:00",
    "correspondenceLetter": {
        "attachmentId": "documents/47086805f7dc4966b4a0c8736b7e32c4",
        "category": "Correspondence Letter",
        "finalDateModified": "8/23/2017 7:53:06 PM +00:00",
        "finalFileName": "Test.pdf",
        "finalId": "documents/47086805f7dc4966b4a0c8736b7e32c4/final",
        "finalName": "Test.pdf",
        "finalVersion": "0.01",
        "originalAttachmentId": "documents/92462005f7dc4966b4a0c8736b7eh4rg"
    },
    "determination": "Modifications Required to Secure \"Approved\"",
    "effectiveDate": "8/23/2017 7:00:00 AM +00:00",
    "finalizedAttachments": [
        {
            "attachmentId": "documents/47086805f7dc4966b4a0c8736b7e32c4",
            "category": "Other",
            "finalDateModified": "8/23/2017 7:53:06 PM +00:00",
            "finalFileName": "Test.pdf",
            "finalId": "documents/47086805f7dc4966b4a0c8736b7e32c4/final",
            "finalName": "Test.pdf",
            "finalVersion": "0.01",
            "originalAttachmentId": "documents/92462005f7dc4966b4a0c8736b7eh4rg"
        }
    ],
    "finalizedConsentForms": [
        {
            "attachmentId": "documents/47086805f7dc4966b4a0c8736b7e32c4",
            "category": "Consent Form",
            "finalDateModified": "8/23/2017 7:53:06 PM +00:00",
            "finalFileName": "Test.pdf",
            "finalId": "documents/47086805f7dc4966b4a0c8736b7e32c4/final",
            "finalName": "Test.pdf",
            "finalVersion": "0.01",
            "originalAttachmentId": "documents/92462005f7dc4966b4a0c8736b7eh4rg"
        }
    ],
    "finalizedRecruitmentMaterials": [
        {
            "attachmentId": "documents/47086805f7dc4966b4a0c8736b7e32c4",
            "category": "Recruitment Materials",
            "finalDateModified": "8/23/2017 7:53:06 PM +00:00",
            "finalFileName": "Test.pdf",
            "finalId": "documents/47086805f7dc4966b4a0c8736b7e32c4/final",
            "finalName": "Test.pdf",
            "finalVersion": "0.01",
            "originalAttachmentId": "documents/92462005f7dc4966b4a0c8736b7eh4rg"
        }
    ],
    "finalizedSponsorAttachments": [
        {
            "attachmentId": "documents/47086805f7dc4966b4a0c8736b7e32c4",
            "category": "Funding Source Attachment",
            "finalDateModified": "8/23/2017 7:53:06 PM +00:00",
            "finalFileName": "Test.pdf",
            "finalId": "documents/47086805f7dc4966b4a0c8736b7e32c4/final",
            "finalName": "Test.pdf",
            "finalVersion": "0.01",
            "originalAttachmentId": "documents/92462005f7dc4966b4a0c8736b7eh4rg"
        }
    ],
    "initialEffectiveDate": "8/23/2017 7:00:00 AM +00:00",
    "lastDayOfApproval": "8/22/2018 7:00:00 AM +00:00",
    "requiredModifications": "Consent form should use the new template",
    "sirbSiteStatus": "Active"
}
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