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

IRBManager portal

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
Form Name Description
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.
Exempt Project Use this form to submit an Exempt Determination for IRB review.
My study is active – how do I submit an amendment or update my study status?
Form Name Description
Amendment Use this form to submit a change in PI, research, study materials, etc. This can be at the master level or site level.
Continuing Review Use this form to submit for continuing review of active research.
Reportable Events Form Use this form to submit a reportable event on an active study.
Closure Form Use this form to submit a closure for a site or master protocol.
Progress Report Form Use this form to submit a progress report for active research that does not require continuing review.
Castle IRB Guidance
Guidance Name Description
Investigator Guide The Investigator Guide sets forth expectations of Investigators conducting studies overseen by Castle IRB.
Castle IRB Meeting Dates and Submission Deadlines
Submission Deadline* Meeting Date*
September 27, 2021 October 6, 2021
October 4, 2021 October 13, 2021
October 11, 2021 October 20, 2021
October 18, 2021 October 27, 2021

*This table reflects routinely scheduled meeting dates; however, Castle IRB can convene additional meetings as needed.

User Accounts and Appropriate Use

Please establish a unique and secure individual Username and Password to access the online portal.  To remain compliant with Castle IRB 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.

Mission Statement

The mission of Castle IRB is to protect the rights and welfare of human participants in gene and cell therapy clinical trials while providing efficient, compliant IRB review of research. Using our portfolio of expertise, we strive to be the leading IRB partner in advancing safe, ethical and compliant gene and cell therapy clinical trials to accelerate the next evolution in advanced therapies.