Study
A multi-site study as uploaded by the sIRB side. When modifications and continuing reviews occur on the study on the sIRB side, this same format is used to upload the changes to the IRB Exchange.
Header
| Name | Type | Description |
|---|---|---|
| name | string |
The name of the study. |
| principalInvestigator | string |
The name of the principal investigator |
| type | string |
The value study |
| version | string |
The value IRBX.2. |
Content
| Name | Type | Description |
|---|---|---|
| approvalDate | date |
The date the study was approved |
| attachments | Array of Document Reference | Other attachments for the study |
| commonRuleLabel | string |
Full label of the Common Rule including FDA and DOJ modifiers |
| consentFormTemplates | Array of Document Reference | Consent form template attachments |
| correspondenceLetter | Document Reference | Correspondence letter |
| currentCommonRule | string |
Current common rule of the study |
| description | string |
Description of the study |
| deviceExemption | string |
Selection of device exemption |
| devices | Array of Device | The devices of the study |
| deviceAttachments | Array of Document Reference | Device attachments |
| drugs | Array of Drug | The drugs of the study |
| drugAttachments | Array of Document Reference | Drug attachments |
| effectiveDate | date |
The last date the review determination was effective |
| fundingSources | Array of FundingSource | Funding sources of the study |
| initialEffectiveDate | string |
The initial date the review determination was effective |
| investigationalDeviceExemptions | Array of InvestigationalDeviceExemption | IDEs |
| investigationalNewDrugs | Array of InvestigationalNewDrugs | INDs |
| isDeviceInvolved | Boolean |
Flag indicating if devices are involved |
| isDrugInvolved | Boolean |
Flag indicating if drugs are involved |
| isStudyUnderInd | Boolean |
Flag indicating if study is under IND |
| lastDayOfApproval | date |
Last day of approval for the study |
| name | string |
Short title |
| piProxies | Array of Person | Persons selected to act as PI proxies |
| preReviewPediatricRiskLevels | string |
Pre-review pediatric risk levels |
| preReviewRiskLevel | string |
Pre-review risk level |
| preReviewMissingMaterials | string |
Pre-review missing materials |
| preReviewNotes | string |
Pre-review notes |
| preReviewSupportingDocuments | Array of Document Reference | Pre-review supporting documents |
| preReviewRegulatoryOversight | Array of string |
Pre-review regulatory oversight |
| preReviewSpecialDeterminationsAndWaivers | Array of string |
Pre-Review special determinations and waivers |
| preReviewResearchType | Array of string |
Pre-review type of research |
| primaryContact | Person | Assigned primary contact Person |
| protocolDocuments | Array of Document Reference | Protocol attachments |
| principalInvestigator | PrincipalInvestigator | Study principal investigator |
| recruitmentMaterialTemplates | Array of Document Reference | Recruitment materials templates attachments |
| studyId | string |
The identifier of the study on the sIRB system. This identifier is primarily used for humans to correlate information when communicating with other collaborating organizations. |
| status | string |
State of the study on the sIRB store |
| title | string |
Long title |
| usesCombinedCommonRule | Boolean |
Boolean which indicates whether study falls under both 2018 and pre-2018 Requirements |
Device Exemption Selection Values
The following table shows the selections supported by the IRB Exchange for study device exemption.
| ID | Description |
|---|---|
| IDE | IDE number |
| HDE | HDE number |
| AbbreviatedIDE | Claim of abbreviated IDE (nonsignificant risk device) |
| Exempt from IDE requirements | Exempt from IDE requirements |
Pre-Review Pediatric Risk Levels Selection Values
The following table shows the selections supported by the IRB Exchange for study pre-review pediatric risk levels.
| Code | Name |
|---|---|
| MIN_RISK | 21 CFR §50.51/45 CFR §46.404: Not involving greater than minimal risk |
| RISK_BENEFIT | 21 CFR §50.52/45 CFR §46.405: Greater than minimal risk; prospect of direct benefit for individual subjects |
| RISK_KNOWLEDGE | 21 CFR §50.53/45 CFR §46.406: Greater than minimal risk; no prospect of direct benefit but likely to yield generalizable knowledge |
| NOT_APPROVABLE | 21 CFR §50.54/45 CFR §46.407: Not otherwise approvable |
Pre-Review Regulatory Oversight Selection Values
The following table shows the selections supported by the IRB Exchange for study pre-review regulatory oversight.
| ID |
|---|
| DOD (Department of Defense) |
| DOE (Department of Energy) |
| DOJ (Department of Justice) |
| ED (Department of Education) |
| EPA (Environmental Protection Agency) |
| FDA (Food and Drug Administration) |
| HHS (Department of Health and Human Services) |
| ICH GCP (International Center for Harmonization of Good Clinical Practice) |
| OCR (Office of Civil Rights) |
| VA (Department of Veterans Affairs) |
| NSF (National Science Foundation) |
| Other federal agency |
| Tribal law |
| None of the above |
Pre-Review Research Type Selection Values
The following table shows the selections supported by the IRB Exchange for study pre-review research type.
| ID |
|---|
| Biomedical / clinical |
| Social / behavioral / educational |
| Other |
Pre-Review Risk Level Selection Values
The following table shows the selections supported by the IRB Exchange for study pre-review risk level.
| ID |
|---|
| Minimal Risk |
| Greater than Minimal Risk |
| None |
Pre-Review Special Determinations and Waivers Selection Values
The following table shows the selections supported by the IRB Exchange for study pre-review special determinations and waivers.
| ID |
|---|
| Broad consent |
| Children |
| Children who are wards of the state |
| Cognitively impaired adults |
| Neonates of uncertain viability |
| Nonsignificant risk device |
| Non-viable neonates |
| Pregnant women |
| Prisoners |
| Students / Employees |
| Waiver of consent documentation |
| Waiver of consent for emergency research |
| Waiver of HIPAA authorization |
| Waiver/alteration of the consent process |
Example
{
"type": "study",
"version": "IRBX.2",
"name": "Advanced research on phylogenetic ctDNA analysis of early stage lung cancer",
"principalInvestigator": "Rebecca Simms"
}
{
"approvalDate": "8/23/2017 7:00:00 AM +00:00",
"attachments": [
{
"attachmentId": "documents/47086805f7dc4966b4a0c8736b7e32c4",
"category": "Other",
"draftDateModified": "8/23/2017 7:04:02 PM +00:00",
"draftFileName": "Test.txt",
"draftId": "documents/47086805f7dc4966b4a0c8736b7e32c4/draft",
"draftName": "Test.txt",
"draftVersion": "0.01",
"finalDateModified": "8/23/2017 7:53:06 PM +00:00",
"finalFileName": "Test.pdf",
"finalId": "documents/47086805f7dc4966b4a0c8736b7e32c4/final",
"finalName": "Test.pdf",
"finalVersion": "0.01"
}
],
"commonRuleLabel": "2018 Requirements",
"consentFormTemplates": [
{
"attachmentId": "documents/47086805f7dc4966b4a0c8736b7e32c4",
"category": "Consent Form",
"draftDateModified": "8/23/2017 7:04:02 PM +00:00",
"draftFileName": "Test.txt",
"draftId": "documents/47086805f7dc4966b4a0c8736b7e32c4/draft",
"draftName": "Test.txt",
"draftVersion": "0.01",
"finalDateModified": "8/23/2017 7:53:06 PM +00:00",
"finalFileName": "Test.pdf",
"finalId": "documents/47086805f7dc4966b4a0c8736b7e32c4/final",
"finalName": "Test.pdf",
"finalVersion": "0.01"
}
],
"correspondenceLetter": {
"attachmentId": "documents/47086805f7dc4966b4a0c8736b7e32c4",
"category": "Correspondence",
"draftDateModified": "8/23/2017 7:04:02 PM +00:00",
"draftFileName": "Test.txt",
"draftId": "documents/47086805f7dc4966b4a0c8736b7e32c4/draft",
"draftName": "Test.txt",
"draftVersion": "0.01",
"finalDateModified": "8/23/2017 7:53:06 PM +00:00",
"finalFileName": "Test.pdf",
"finalId": "documents/47086805f7dc4966b4a0c8736b7e32c4/final",
"finalName": "Test.pdf",
"finalVersion": "0.01"
},
"currentCommonRule": "2018 Requirements",
"description": "This study will save the world.",
"deviceExemption": "ID00000001",
"devices": [
{
"id": "uuid:f8c716133bcd4ed0b44a573a3126f777",
"isHumanitarianUseDevice": false,
"name": "IBV Valve System",
"documents": [
{
"attachmentId": "documents/47086805f7dc4966b4a0c8736b7e32c4",
"category": "Device Attachment",
"draftDateModified": "8/23/2017 7:04:02 PM +00:00",
"draftFileName": "Test.txt",
"draftId": "documents/47086805f7dc4966b4a0c8736b7e32c4/draft",
"draftName": "Test.txt",
"draftVersion": "0.01",
"finalDateModified": "8/23/2017 7:53:06 PM +00:00",
"finalFileName": "Test.pdf",
"finalId": "documents/47086805f7dc4966b4a0c8736b7e32c4/final",
"finalName": "Test.pdf",
"finalVersion": "0.01"
}
]
}
],
"deviceAttachments": [
{
"attachmentId": "documents/47086805f7dc4966b4a0c8736b7e32c4",
"category": "Device Attachment",
"draftDateModified": "8/23/2017 7:04:02 PM +00:00",
"draftFileName": "Test.txt",
"draftId": "documents/47086805f7dc4966b4a0c8736b7e32c4/draft",
"draftName": "Test.txt",
"draftVersion": "0.01",
"finalDateModified": "8/23/2017 7:53:06 PM +00:00",
"finalFileName": "Test.pdf",
"finalId": "documents/47086805f7dc4966b4a0c8736b7e32c4/final",
"finalName": "Test.pdf",
"finalVersion": "0.01"
}
],
"drugs": [
{
"brandName": "Adenocard",
"documents": [
{
"attachmentId": "documents/47086805f7dc4966b4a0c8736b7e32c4",
"category": "Drug Attachment",
"draftDateModified": "8/23/2017 7:04:02 PM +00:00",
"draftFileName": "Test.txt",
"draftId": "documents/47086805f7dc4966b4a0c8736b7e32c4/draft",
"draftName": "Test.txt",
"draftVersion": "0.01",
"finalDateModified": "8/23/2017 7:53:06 PM +00:00",
"finalFileName": "Test.pdf",
"finalId": "documents/47086805f7dc4966b4a0c8736b7e32c4/final",
"finalName": "Test.pdf",
"finalVersion": "0.01"
}
],
"genericName": "adenosine",
"id": "uuid:26fa85326bff4282a92c63d6b4d9a23b"
}
],
"drugAttachments": [
{
"attachmentId": "documents/47086805f7dc4966b4a0c8736b7e32c4",
"category": "Drug Attachment",
"draftDateModified": "8/23/2017 7:04:02 PM +00:00",
"draftFileName": "Test.txt",
"draftId": "documents/47086805f7dc4966b4a0c8736b7e32c4/draft",
"draftName": "Test.txt",
"draftVersion": "0.01",
"finalDateModified": "8/23/2017 7:53:06 PM +00:00",
"finalFileName": "Test.pdf",
"finalId": "documents/47086805f7dc4966b4a0c8736b7e32c4/final",
"finalName": "Test.pdf",
"finalVersion": "0.01"
}
],
"effectiveDate": "8/23/2017 7:00:00 AM +00:00",
"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",
"draftName": "Test.txt",
"draftVersion": "0.01",
"finalDateModified": "8/23/2017 7:53:06 PM +00:00",
"finalFileName": "Test.pdf",
"finalId": "documents/47086805f7dc4966b4a0c8736b7e32c4/final",
"finalName": "Test.pdf",
"finalVersion": "0.01"
}
]
}
],
"initialEffectiveDate": "8/23/2017 7:00:00 AM +00:00",
"investigationalDeviceExemptions": [
{
"id": "uuid:1966eaed8aec41aa9a27ec9144fdd0f0",
"number": "HDE298732109",
"holder": "Investigator"
}
],
"investigationalNewDrugs": [
{
"id": "uuid:1966eaed8aec41aa9a27ec9144fdd0f0",
"number": "IND21010",
"holder": "Sponsor"
}
],
"isDeviceInvoled": true,
"isDrugInvolved": true,
"isStudyUnderInd": true,
"lastDayOfApproval": "8/22/2018 7:00:00 AM +00:00",
"name": "Test Study",
"piProxies": [
{
"id": "ec8ff2cbadb74231ba059878820fdc63",
"firstName": "Jack",
"lastName": "Smith",
"email": "testuser@huronclick.com"
}
],
"preReviewRiskLevel": "ID00000001",
"preReviewMissingMaterials": "Consent form template is missing risk statements",
"preReviewNotes": "Consent form templates will need some work",
"preReviewSupportingDocuments": [
{
"draftDateModified": "8/23/2017 7:04:02 PM +00:00",
"draftFileName": "Test.txt",
"draftId": "documents/47086805f7dc4966b4a0c8736b7e32c4/draft",
"draftName": "Test.txt",
"draftVersion": "0.01"
}
],
"preReviewRegulatoryOversight": [
"DOD (Department of Defense)",
"DOE (Department of Energy)"
],
"preReviewSpecialDeterminationsAndWaivers": [
"ID00000042",
"ID00000045"
],
"preReviewResearchType": [
"ID00000001",
"ID00000003"
],
"primaryContact": {
"id": "ui9ff2cbadb74231ba059878820fdd77",
"firstName": "John",
"lastName": "Smith",
"email": "jsmith@huronclick.com"
},
"protocolDocuments": [
{
"attachmentId": "documents/47086805f7dc4966b4a0c8736b7e32c4",
"category": "IRB Protocol",
"draftDateModified": "8/23/2017 7:04:02 PM +00:00",
"draftFileName": "Test.txt",
"draftId": "documents/47086805f7dc4966b4a0c8736b7e32c4/draft",
"draftName": "Test.txt",
"draftVersion": "0.01",
"finalDateModified": "8/23/2017 7:53:06 PM +00:00",
"finalFileName": "Test.pdf",
"finalId": "documents/47086805f7dc4966b4a0c8736b7e32c4/final",
"finalName": "Test.pdf",
"finalVersion": "0.01"
}
],
"principalInvestigator": {
"id": "nh4ff2cbadb74231ba059878820fdr34",
"firstName": "Joan",
"lastName": "Smith",
"email": "joansmith@huronclick.com",
"hasFinancialInterest": false
},
"recruitmentMaterialTemplates": [
{
"attachmentId": "documents/47086805f7dc4966b4a0c8736b7e32c4",
"category": "Recruitment Materials",
"draftDateModified": "8/23/2017 7:04:02 PM +00:00",
"draftFileName": "Test.txt",
"draftId": "documents/47086805f7dc4966b4a0c8736b7e32c4/draft",
"draftName": "Test.txt",
"draftVersion": "0.01",
"finalDateModified": "8/23/2017 7:53:06 PM +00:00",
"finalFileName": "Test.pdf",
"finalId": "documents/47086805f7dc4966b4a0c8736b7e32c4/final",
"finalName": "Test.pdf",
"finalVersion": "0.01"
}
],
"studyId": "STUDY00000001",
"status": "Approved",
"title": "Long title of Test Study",
"usesCombinedCommonRule": false
}