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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
Q-Is there Reference of latest PHUSE BDRG in latest FDA CDER BIMO TCG?
A-Yes,
As per latest FDA CDER BIMO TCG V3.0 (11th August , 2022), Page 2, there is a footnote 4 that references and provides a link for the latest version of PHUSE BDRG (Hint: Within the link click on "Bio-research Monitoring Data Reviewers Guide (BDRG) Package" that should open latest version of PHUSE BDRG. We believe this footer link would be available in the future FDA CDER BIMO TCG release as well).
Please reference the below snapshot from the latest FDA CDER BIMO TCG V3.0 (11th August , 2022), Page 2, footnote 4
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
Q-Among Investigator (Current Principal Clinical Investigator AND/or multiple Sub-Investigators) for a SITE, which of investigator information should be reported in Part I (Item A) – List of All Clinical Sites as well as in Part III – Summary-level Clinical Site Dataset?
A- As per FDA CDER BIMO TCG :-
For BIMO Part I (Item A) – List of All Clinical Sites PDF deliverable for each of the major (i.e. pivotal) studies for each SITE that participated in the study (i.e. SITE that have screened one subject with a signed informed consent) there is Current Principal Clinical Investigator information .i.e. LAST NAME, FIRST NAME,Middle INITIAL,PHONE, FAX and EMAIL (along with Prior Principal Clinical Investigator(s) information<if applicable> .i.e. LAST NAME, FIRST NAME,Middle INITIAL,PHONE, FAX and EMAIL) information needs to be provided as recommended in the 2nd and 4th column as per format "APPENDIX 1: CLINICAL STUDY-LEVEL INFORMATION, Table A: Format for Clinical Site Lists" mentioned in the latest FDA CDER BIMO TCG version 3.0.
For Part III – Summary-level Clinical Site Dataset deliverable for each of the major (i.e. pivotal) studies for each SITE that participated in the study (i.e. SITE that have screened one subject with a signed informed consent) there is ONLY Current Principal Clinical Investigator Information .i.e. LAST NAME, FIRST NAME,Middle INITIAL,PHONE,FAX and EMAIL information needs to be provided as separate variables in the clinsite data set (But, NO Prior Principal Clinical Investigator(s) information AND NO multiple Sub-Investigators NAME information is needed).