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"
}