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 — Meeting Schedule
- IRB Membership List (Current)
- 2022 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™ Getting Started
- Request for User Access – Submit form to obtain an IRBManager account.
Send completed Request for User Access forms to useraccess@brany.com
- IRBManager™ Demonstration Webinar
- WEBINAR: IRBManager & xForms Basics
- Live webinar on the 1st Tuesday of the month. Email: useraccess@brany.com to register.
Continuing Review
- Minor Deviation Log
- Supplement for Multi-Center Research Projects
For Multi-Center Research Projects — BRANY IRB requires a representative of the Study Sponsor, the Lead Investigator, or the Master File site PI for a multi-site study to provide a brief summary of study-wide progress and findings, including study-wide subject accrual data, adverse event data, unanticipated problem reports, safety updates, recent literature, and any other interim findings or available study-wide progress information. This information is intended to assist the IRB in evaluating how the site-specific data and progress reported by local PIs with continuing review applications compare to the study-wide data and progress.
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 — Meeting Schedule
- IRB Membership List (Current)
- 2022 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™ Getting Started
- Request for User Access – Submit form to obtain an IRBManager account. Send completed Request for User Access forms to useraccess@brany.com
- IRBManager™ Demonstration Webinar
- WEBINAR: IRBManager & xForms Basics
- Live webinar on the 1st Tuesday of the month. Email: useraccess@brany.com to register.
Continuing Review
- Minor Deviation Log
- Supplement for Multi-Center Research Projects For Multi-Center Research Projects — BRANY IRB requires a representative of the Study Sponsor, the Lead Investigator, or the Master File site PI for a multi-site study to provide a brief summary of study-wide progress and findings, including study-wide subject accrual data, adverse event data, unanticipated problem reports, safety updates, recent literature, and any other interim findings or available study-wide progress information. This information is intended to assist the IRB in evaluating how the site-specific data and progress reported by local PIs with continuing review applications compare to the study-wide data and progress.
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