Forms & Downloads
Reporting Timelines
| UPIRTSOS (Unanticipated Problems) | Report per occurrence within 5 days |
| Serious Adverse Events (Local) | Report per occurrence within 5 days |
| Unanticipated Adverse Device Events (UADEs) | Report per occurrence within 10 days |
| Complaints | Report per occurrence within 5 days |
| Major Deviations | Report per occurrence within 10 days |
| Minor Deviations | Report in aggregate with continuing review or study closure |
Link to Reportable Events guidance documents.
IRB Forms & Downloads
IRB Membership List — Compliance Statement
- IRB Membership List (Current)
- BRANY IRB Compliance Statement
- BRANY IRB Registration
BRANY IRB is registered per 45 CFR 46 Subpart E and 21 CFR 56.106 (Registration #IRB00000080 and #IRB00010793)
- Note to File – BRANY IRB Address Change – No Change to 1572 Required
Initial Submission or Exemption Request
- Submission Guidance – Documents to attach to xForms
- IRB Authorization Agreement Template
- Guideline for Drafting a Clinical Protocol
- Write protocols more efficiently with Protocol Builder software
- Transfer of IRB Oversight – Contact BRANY IRB
- Requirements for Human Subject Protection Training
- Frequently Asked Questions – Study Personnel
- Conflict of Interest Form (Combined Form 01 & 02)
IRBManager™ (One Aegis) Getting Started
- New users: Go to the login screen. Use the Click here to register link to enable your account.
- IRBManager™ & xForms Basics Webinar
- Live webinar on the 1stTuesday of the month.
- To register, log into the portal. Download the calendar invite under BRANY Notices.
Continuing Review
- Minor Deviation Log
- NOTE: BRANY IRB has updated its policy to no longer require submission of Minor Deviations.
- Submission forms started after November 1, 2026 will no longer require attachment of the Minor Deviation Log (i.e., continuing review, annual status reports, and study closure forms).
- Need to find your Continuing Review or Annual Status Report xForm?
- Continuing Review and Annual Status Report xForms become available in your Study-Site workspace 45 days before the due date.
- When the form is available, the PI and Study-Site Contacts will receive an automated email alert from the BRANY submission system with a direct link to the form.
Reportable Events (Deviations, Unanticipated Problems, Complaints, Adverse Events)
.
-
- Information Sheet – Protocol Deviations
- Information Sheet – Protocol Exceptions
- Information Sheet – Unanticipated Problems
- Information Sheet – Serious Adverse Events
- Frequently Asked Questions – Reporting Deviations
- Frequently Asked Questions – Corrective and Preventive Actions (CAPA)
- Minor Deviation Log
• NOTE: BRANY IRB has updated its policy to no longer require submission of Minor Deviations.
• Submission forms started after November 1, 2026 will no longer require attachment of the Minor Deviation Log (i.e., continuing review, annual status reports, and study closure forms).
IRB Forms & Downloads
IRB Membership List — Compliance Statement
- IRB Membership List (Current)
- BRANY IRB Compliance Statement
- BRANY IRB Registration
BRANY IRB is registered per 45 CFR 46 Subpart E and 21 CFR 56.106 (Registration #IRB00000080 and #IRB00010793) - Note to File – BRANY IRB Address Change – No Change to 1572 Required
Initial Submission or Exemption Request
- Submission Guidance – Documents to attach to xForms
- IRB Authorization Agreement Template
- Guideline for Drafting a Clinical Protocol
- Write protocols more efficiently with Protocol Builder software
- Transfer of IRB Oversight – Contact BRANY IRB
- Requirements for Human Subject Protection Training
- Frequently Asked Questions – Study Personnel
- Conflict of Interest Form (Combined Form 01 & 02)
IRBManager™ (One Aegis) Getting Started
- New users: Go to the login screen. Use the Click here to register link to enable your account.
- IRBManager™ & xForms Basics Webinar
- Live webinar on the 1stTuesday of the month.
- To register, log into the portal. Download the calendar invite under BRANY Notices.
Continuing Review
- Minor Deviation Log
- NOTE: BRANY IRB has updated its policy to no longer require submission of Minor Deviations.
- Submission forms started after November 1, 2026 will no longer require attachment of the Minor Deviation Log (i.e., continuing review, annual status reports, and study closure forms).
- Need to find your Continuing Review or Annual Status Report xForm?
- Continuing Review and Annual Status Report xForms become available in your Study-Site workspace 45 days before the due date.
- When the form is available, the PI and Study-Site Contacts will receive an automated email alert from the BRANY submission system with a direct link to the form.
Reportable Events (Deviations, Unanticipated Problems, Complaints, Adverse Events)
.
-
- Information Sheet – Protocol Deviations
- Information Sheet – Protocol Exceptions
- Information Sheet – Unanticipated Problems
- Information Sheet – Serious Adverse Events
- Frequently Asked Questions – Reporting Deviations
- Frequently Asked Questions – Corrective and Preventive Actions (CAPA)
- Minor Deviation Log
• NOTE: BRANY IRB has updated its policy to no longer require submission of Minor Deviations.• Submission forms started after November 1, 2026 will no longer require attachment of the Minor Deviation Log (i.e., continuing review, annual status reports, and study closure forms).