IREx Integration (API) NEW

IREx Integration (API)

The irex api: an overview

The goal of the IREx API is to exchange data between a single IRB’s (sIRB) local electronic IRB (e-IRB) system and the IRB Reliance Exchange (IREx). Given that IREx captures (a) all the information an sIRB needs to review and grant initial IRB approval for a participating site and (b) the actual IRB approval information and documents for participating sites, the IREx API will facilitate bi-directional data exchange. The sIRB can pull participating site information from IREx into its e-IRB system for review and push participating site approvals to IREx to facilitate sIRB communications and approval notifications.

A study submitted in an sIRB’s local electronic IRB (e-IRB) system is copied into IREx with just the click of a button. The study title, description, IRB number, key dates, protocol file, and PI information are registered in IREx so the sIRB doesn’t have to double enter the data from their system.

Required Fields

  • IRB number (Project ID)
  • Study Title
  • Lay Summary
  • Draft protocol or executive summary
  • Protocol version # or name
  • Date application was submitted
  • Date application was pre-reviewed
  • Submission Type

Optional Fields: Risk type & Minimal Risk Categories

Completing the IREx Setup (completed manually by sIRB within IREx)

  1. Indicate whether Reviewing IRB Institution is also the Lead Site (Y/N)
  2. Indicate whether IREx is being used to capture local considerations (Y/N)
  3. Indicate whether an LOI is required (Y/N)
  4. Designate a primary IRB liaison/point of contact for the sIRB from a pre-populated list of liaisons
  5. Grant the IREx Study Manager (e.g., coordinating center/lead coordinator) access (First / Last Name, email)
  6. Confirm the Study-Specific Reliance Plan (SSRP) (default answers pulled from your Institutional Profile)
  7. Add participating sites to study in IREx (Name or FWA # and component information).

Note: If your IRB system captures the data for the items above, we can discuss adding these fields to the API so no one has to login to answer these items.

Information about the IRB approval (see table) are synchronized with the study in IREx using the Project ID.

Required Fields

  • IRB number (Project ID)
  • Risk type
  • Minimal risk categories
  • Submission type (initial, continuing review, etc.)
  • Review cycle
  • Date reviewed
  • Date approved
  • Expiration date

Optional Fields

  • Determination letter
  • Consents
  • Protocol
  • IRB application
  • “Other” documents + Personnel F/L Names, Email & Role

All the information the sIRB needs to review and grant initial IRB approval for a site is pulled from IREx into the sIRB’s local e-IRB system.

Available Fields

  • IRB number (Project ID)
  • Parent site name
  • Site / component name
  • Site FWA #
  • FWA expiration date
  • IRB registry #s
  • AAHRPP Accreditation Status
  • Site signed LOI
  • Site signed SMART
  • Date of cede decision/accepted SSRP
  • Local HRPP submission date
  • Local HRPP review start date
  • Local HRPP review completion date
  • PI Survey completion date
  • PI Survey modified date
  • HRPP survey completion date
  • HRPP survey modified date
  • Site Personnel (F/L Names, email, role)
  • Documents: Institutional Profile, HRP Survey, PI Survey, Notification of Reliance, SSRP

Similar to Phase II, this will allow the sIRB to push the approval information and documents for participating sites into IREx, which automatically notifies the participating site’s HRPP and study of their new approval.

Required Fields

  • IRB number (Project ID)
  • Date site submitted
  • Date site reviewed
  • Date site approved
  • Submission Type
  • Determination Letter
  • Consents (if not waived)

Optional Fields: “Other” documents 

Getting connected

Connecting your system to the IREx API will require someone with technical expertise at your site who can program your system to communicate with the API.  If you use a commercially available system, we may already have a solution to facilitate the API implementation. 

If you would like to get started with the IREx API:

  • Contact the IREx administrators (admin@IRBExchange.org) to discuss implementing the API with your local IRB system. We will determine if you can use an existing solution to connect your system to the API or if you will need to build a custom solution.
  • Once your system is ready, we’ll send you the credentials to connect with our test site and verify that your system is communicating correctly with IREx. If you run into any issues, our friendly technical staff will assist you in getting everything working.
  • Finally, once you are successfully communicating with our test site, we will send you the credentials to start pushing real data to IREx.