Forms & Downloads
|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
- Submission Guidance – Documents to attach to xForms
- IRB Authorization Agreement Template
- Guideline for drafting a clinical protocol
- Transfer of IRB Oversight – Contact BRANY IRB
- Requirements for Human Subject Protection Training
- Form 01 - COI Disclosure Statement
- FORM 02: Conflict Report Form (only needed if answered “YES” on Form 01)
- Request for User Access – Submit form to obtain an IRBManager account.
Send completed Request for User Access Forms by email to Svetlana Abramova (or fax# 516-706-5066)
- Which xForm should I use?
- IRBManager™ Demonstration Webinar
- Check the box to request a demonstration on the Request for User Access form
- Email email@example.com
- 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.
BRANY IRB does not require submission of external (off-site) adverse event reports unless they meet the criteria for an Unanticipated Problem.