Castle IRB Portal

Use the IRBManager portal to submit IRB forms, retrieve approval letters/study documents, and submit modifications, reportable events, and other updates on existing studies.

Would you like a personalized online demo with our IRB team?

Email us at clientservices@castleirb.com to schedule a personalized online demo to answer all your questions and confirm what form to start – or to request personalized instructions on how to get started.

Castle IRB Forms

Note: Submission forms are only available in the Online Portal. Guidance for completing online forms is available below.

Exempt Project

Use this form to submit an Exempt Determination for IRB review.

Multisite Initial Protocol Application

Sponsors of multi-site studies use this form to submit a new master protocol for Initial Review.

Single Site Application

Use this form to submit a new protocol for single site Initial Review.

Site Application

Use this form to add an Investigator/site to a multisite protocol that has already been approved by Castle IRB.

Single Patient Expanded Access Application

Use this form to submit an application for single patient expanded access/compassionate use.

Retrieve documents, submit amendments or update your study status

Note: Submission forms are only available in the Online Portal. Guidance for completing online forms is available below.

Add or Remove Contacts

Use this form to add or remove contacts.

Add Translations to an Active Study

Use this form to add translation(s) to an active study.

Amendment

Use this form to submit a change in PI, research, study materials, etc. This can be at the master level or site level.

Closure Form

Use this form to submit a closure for a site or master protocol.

Reportable Events Form

Use this form to submit a reportable event on an active study.

Retrieve Approval Letters & Documents

Click link to the left for guidance on how to access approval letters and approved study documents.

Submit a New Contact Form

Use this form to submit a new contact form.

Castle IRB Guidance

Reportable Events

Recruitment Guidelines

Investigator Guide

The Investigator Guide sets forth expectations of Investigators conducting studies overseen by Castle IRB.

Single Patient Expanded Access Resource Guide

Exempt Categories

Expedited Review

Upcoming meeting dates/submission deadlines

Sabai IRB Services offers four Board Meetings per week (Monday, Wednesday (2) and Friday).
Ad hoc meetings can be scheduled as needed with the IRB team. Please see submission deadline information below.

Castle IRB Meeting Dates and Submission Deadlines

Wednesday/Friday Board

Submission Deadline: (5:00 pm Central Time)*Meeting Date*
June 17, 2024June 26, 2024
June 19, 2024June 28, 2024
June 24, 2024July 3, 2024
June 26, 2024July 5, 2024
July 1, 2024July 10, 2024
July 3, 2024July 12, 2024
July 8, 2024July 17, 2024
July 10, 2024July 19, 2024
July 15, 2024July 24, 2024
July 17, 2024July 26, 2024
July 22, 2024July 31, 2024
July 24, 2024August 2, 2024
July 29, 2024August 7, 2024
July 31, 2024August 9, 2024

*This table reflects routinely scheduled meeting dates; however, Castle IRB can convene additional meetings as needed. Submissions must be received the Monday before the following week’s Wednesday board meeting, and the Wednesday before the following week’s Friday board meeting. Turnaround time: 10 business days or less from study submission to IRB review and determination letter distribution.

Expedited Reviews, Exempt Reviews, Human Subjects Research Determinations, and Generic Material Reviews have no submission deadlines and are reviewed upon receipt. Single Patient Expanded Access Applications may be reviewed outside of a convened Full Board Meeting. However, if a Single Patient Expanded Access application requires Full Board review, Sabai IRB Services is sensitive to the urgency of the situation when scheduling the application for review.

Board Rosters

Current Board Members

Previous Board Members (2020-2024)

User Accounts and Appropriate Use

Please establish a unique and secure individual Username and Password to access the online portal. To remain compliant with our Electronic Signature Policies and applicable Federal Regulations, including FDA 21 CFR Part 11, it is required that all users access the online portal only with their unique ID and password, and that users do not share their username/password with others. Submissions to Castle IRB in the online portal will utilize your electronic signature, which is the legally binding equivalent to your handwritten signature. You will be asked to re-enter your password each time you apply your electronic signature. Each individual user is accountable and responsible for actions initiated under their electronic signature.

Contact support@castleirb.com for help with access issues or if you suspect that your account has been breached.

For assistance with your submission: Please call 888-442-2472 x 702 or email irbteam@castleirb.com.

Browser Requirements: Internet Explorer is not compatible with Castle IRB’s online portal and should not be used. Other browsers are compatible.