Table of contents

About

 BIMO

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 PHUSE BIMO FAQ Forum Project

 How to effectively utilize PHUSE BIMO FAQ Forum Project

 Acronyms used in PHUSE BIMO FAQ Forum Project

BIMO Submission Helpful Resources

 FDA portal

 PHUSE portal

 White paper [Useful and applicable]

BIMO Submission Standards / Guidance

 Standardized Format for Electronic Submission of BIMO

 BIMO Technical Conformance Guide (TCG)

 Difference between FDA CDER Vs FDA CBER BIMO submission

 Pre-Submission FDA Meeting Planning/Discussion

 BIMO Clinical Data consistency with SDTM/ADAM

 BDRG consistency with cSDRG/ADRG

 Consistency among BIMO Submission to FDA

BIMO Submission Deliverables

 Part I (Item A) - List of All Clinical Sites

 Part I (Item B) - Entities Contact Information and Trial-related Files

 Part I (Item C1) - Protocol and Amendments

 Part I (Item C2) - Annotated Case Report Form (aCRF)

 Part II - Subject-level Data Line Listings by Clinical Site

 Part III - Summary-level Clinical Site Dataset

 Part IV - BIMO Data Reviewer’s Guide (BDRG)

 General

eCTD Folder Structure for BIMO

About eCTD

How your BIMO preparation and submission is related to eCTD

Where and how to use eCTD within BIMO submission to FDA

Submitting BIMO Clinical Data in the eCTD Format

BIMO Submission Conformance Rules

Is it mandatory (Yes or No)

BIMO deliverable applicable and where to document

Guidance/Recommendation for BIMO submission conformance rules

General BIMO Submission - Inspections Questions and Sponsor Response

 Type of FDA IRs

 BIMO Submission FDA inspection questions and Sponsor response

 Impact of notifying valid missing information on FDA Inspections