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.
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
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* |
| November 4, 2024 | November 13, 2024 |
| November 6, 2024 | November 15, 2024 |
| November 11, 2024 | November 20, 2024 |
| November 13, 2024 | November 22, 2024 |
| November 18, 2024 | November 27, 2024 |
| November 25, 2024 | December 4, 2024 |
| November 27, 2024 | December 6, 2024 |
| December 2, 2024 | December 11, 2024 |
| December 4, 2024 | December 13, 2024 |
| December 9, 2024 | December 18, 2024 |
| December 11, 2024 | December 20, 2024 |
| December 27, 2024 | January 3, 2025 |
*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.
- Main study review turnaround time: typically 5 business days or less from study submission to IRB review and Determination Letter distribution
- PI/site (multi-investigator projects): 2-3 days from PI/site submission following main study review
- Generic review: 2-3 days
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.
