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Facilitated by :-

Dr. M.P. Venkatesh

Assistant Professor

Dept. of Pharmaceutics,

Regulatory Affairs Group

JSSCP, Mysuru

Presented by :-

Mr. Shankargouda R Patil

1st M –Pharm

Pharmaceutical Regulatory

Affairs

JSSCP, Mysuru

1st EVALUATION SEMINAR

Bioresearch Monitoring Program

International pharmaceutical regulation 1

Introduction

Bioresearch Monitoring (BIMO) program is a

comprehensive program of on-site inspections and data

audits designed to monitor all aspects of the conduct and

reporting of FDA regulated research.

The BIMO Program was established to assure the quality

and integrity of data submitted to the agency in support

of new product approvals,

It also provides for protection of the rights and welfare of

the thousands of human subjects involved in FDA regulated

research

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It has become a cornerstone of the FDA

preapproval process for new medicines, medical

devices, food and color additives and veterinary

products introduced to the U.S. consumer

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BIMO Program Objectives

Protect the rights, safety, and welfare of

human research subjects

Assure the quality, reliability, and integrity of

data collected

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BIMO Program Functions

Audit clinical data

Inspect ongoing clinical research

Inspect nonclinical laboratories

Inspect Institutional Review Boards (IRBs)

Educate and train

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What may Prompt an Inspection of

Device Research?

New Product or Indication

New Technology

Complaints

History of non-compliance

Routine Surveillance

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BIMO Inspection Programs

Routine

– Surveillance

– Compliance follow-up

Directed

– Data audits of device submissions

For Cause

– Investigate problems

– Investigate complaints 7

Classification of inspection

NAI – No Action Indicated

The FDA field inspector did not identified objectionable

Practice (or) identify only minor issue that did not justify further action

VAI – Voluntary Action Indicated

Indicates that objectionable Practices were uncovered during that

inspection. But were not significant

OAI – Official Action Indicated

Inspection uncovered significant objectionable practices. Which

could affect data reliability (or) compromise human subject protection

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BIMO Compliance Programs

Clinical Investigators (CI)

Sponsors,

Contract Research Organizations, and

Monitors

Institutional Review Boards (IRB)

Good Laboratory Practices (GLP)

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Clinical Investigator (CI)

An individual who actually conducts a clinical

investigation, under whose immediate direction the

test article is administered, dispensed, or used.

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Sponsor

Takes responsibility for and initiates a clinical

investigation, but does not actually conduct the

investigation

Sponsor May be an individual, company,

government agency, academic institution, private

organization11

Monitor

Individual designated by a sponsor or contract

research organization to oversee the progress of

an investigation

Must be qualified by training and experience to

monitor the device investigation

monitoring heart rhythms12

Contract Research Organization (CRO)

A person who assumes, as an independent

contractor with the sponsor, one or more of the

obligations of a sponsor

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Institutional Review Board (IRB)

Any board, committee, or other group formally

designated by an institution to review to

approve the initiation of and conduct periodic

review of biomedical research involving human

subjects

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Sponsor-Investigator (SI)

An individual who both initiates and actually

conducts, alone or with others, an investigation,

and under whose immediate direction the

investigational product is administered,

dispensed, or used. The obligations include

both those of a sponsor and an investigator

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Non-Clinical Laboratories

Animal laboratories where pre-clinical

studies are conducted

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FDA Regulations that apply to BIMO

21 CFR 50: Protection of Human Subjects

21 CFR 54: Financial Disclosure

21 CFR 56: Institutional Review Boards(IRB)

21 CFR 58: Good Laboratory Practice

for Non-Clinical Laboratory Studies (GLP)

21 CFR 809: In Vitro Diagnostic Products(IVD)

21 CFR 812: Investigational Device Exemption (IDE)

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Guidance and Information

Computerized Systems Used in Clinical

Investigations,

Protecting the Rights, Safety, and Welfare of

Study Subjects – Supervisory Responsibilities of

Investigators,

The Review and Inspection of Premarket

Approval Applications under the Bioresearch

Monitoring Program,

Guidance for Sponsors, Clinical Investigators,

and IRBs – Data Retention When Subjects

Withdraw from FDA-regulated clinical trials, 18

Reference

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http://www.fda.gov/ICECI/EnforcementActions/DisqualifiedRestricted

AssuranceList/ucm132596.htm

https://docs.google.com/viewerng/viewer?url=http://www.fda.gov/do

wnloads/Training/CDRHLearn/UCM176440.pdf

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