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
- 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
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
- 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