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 |
IRB Forms & Downloads
IRB Membership List — Compliance Statement — Meeting Schedule
- IRB Membership List (Current)
- BRANY IRB Calendar
- 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)
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
- Which xForm should I use?
- 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.
External (off-site) Adverse Events
BRANY IRB does not require submission of external (off-site) adverse event reports unless they meet the criteria for an Unanticipated Problem.
IRB Forms & Downloads
IRB Membership List — Compliance Statement — Meeting Schedule
- IRB Membership List (Current)
- BRANY IRB Calendar
- 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)
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 - Which xForm should I use?
- 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.
External (off-site) Adverse Events
BRANY IRB does not require submission of external (off-site) adverse event reports unless they meet the criteria for an Unanticipated Problem.