Site Continuing Review

Continuing review data for the Site as uploaded by the pSite side.

Header

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

Content

Name	Type	Description
comments	string	Comments about the site continuing review
enrolledSinceLastApproval	number	The number of participants enrolled since last approval
reportedDate	date	The date the continuing review was reported for the site
statements	Array of string	IDs of selected statements on the site continuing review
supportingDocuments	Array of Document Reference	Supporting documents related to the site continuing review
totalEnrollment	number	The total number of participants enrolled for the site

Statements Selection Values

The following table shows the selections supported by the IRB Exchange for site continuing review statements.

ID
NO subjects experienced unexpected harm
Anticipated adverse events have NOT taken place with greater frequency or severity than expected
NO subjects withdrew from the study
NO unanticipated problems involving risks to subjects or others
NO complaints about the study
NO publications in the literature relevant to risks or potential benefits
NO interim findings
NO multi-center trial reports
NO data safety monitoring reports
NO regulatory actions that could affect safety and risk assessments
NO other relevant information regarding this study, especially information about risks
In the opinion of the PI, the risks and potential benefits are unchanged
All modifications to the protocol have been submitted to the IRB
All problems that require prompt reporting to the IRB have been submitted
NO internal or local serious adverse events in Veterans Administration (VA) research

Example

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

{
    "comments": "We had a surge of participants enroll this period."
    "enrolledSinceLastApproval": 50,
    "statements": [
        "ID00000007",
        "ID00000015"
    ],
    "supportingDocuments": [
        {
            "draftDateModified": "8/23/2017 7:04:02 PM +00:00",
            "draftFileName": "Test.txt",
            "draftId": "documents/47086805f7dc4966b4a0c8736b7e32c4/draft",
            "draftName": "Test.txt",
            "draftVersion": "0.01"
        }
    ],
    "totalEnrollment": 60
}