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  • About

    •  BIMO

    •  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


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