Use the IRBManager portal to submit IRB forms, retrieve approval letters/study documents, and submit modifications, reportable events, and other updates on existing studies.
Click here for instructions on how to create an IRB Manager account.
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.
| Form Name (Click Link for Guidance) | Description |
|---|---|
| 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. |
| Form Name (Click Link for Guidance) | Description |
|---|---|
| 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. |
| Continuing Review | Use this form to submit for continuing review of active research. |
| Progress Report Form | Use this form to submit a progress report for active research that does not require continuing review. |
| 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. |
| Guidance Name | Description |
|---|---|
| Investigator Guide | The Investigator Guide sets forth expectations of Investigators conducting studies overseen by Castle IRB. |
| Submission Deadline (5:00 pm Central Time)* | Meeting Date* |
|---|---|
| December 4, 2023 | December 13, 2023 |
| December 11, 2023 | December 20, 2023 |
| December 27, 2023 | January 3, 2024 |
| January 2, 2024 | January 10, 2024 |
| January 8, 2024 | January 17, 2024 |
| January 15, 2024 | January 24, 2024 |
| January 22, 2024 | January 31, 2024 |
*This table reflects routinely scheduled meeting dates; however, Castle IRB can convene additional meetings as needed.
| Submission Deadline (5:00 pm Central Time)* | Meeting Date* |
|---|---|
| December 6, 2023 | December 15, 2023 |
| January 3, 2024 | January 12, 2024 |
| January 10, 2024 | January 19, 2024 |
| January 17, 2024 | January 26, 2024 |
| January 24, 2024 | February 2, 2024 |
| January 31, 2024 | February 9, 2024 |
| February 7, 2024 | February 16, 2024 |
*This table reflects routinely scheduled meeting dates; however, Castle IRB can convene additional meetings as needed.
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.
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