Introduction into t

Bioresearch Monitoring P

Introduction into t

Bioresearch Monitoring P

Presented by Janet H. Cooper, BS 

Consumer Safety OfficerDivision of Bioresearch Monitoring

Office of Compliance

Center for Devices and Radiologica

Presented by Janet H. Cooper, BS 

Consumer Safety OfficerDivision of Bioresearch Monitoring

Office of Compliance

Center for Devices and Radiologica
Objectives Objectives

z Explain the objectives of the FDA

Bioresearch Monitoring Program

z Recognize the specific roles invol

device clinical trials

z Describe the different compliance z Identify the FDA regulations that a

BIMO

z Understand where to obtain addit

information

z Explain the objectives of the FDA’

Bioresearch Monitoring Program

z Recognize the specific roles involv

device clinical trials

z Describe the different compliance z Identify the FDA regulations that a

BIMO

z Understand where to obtain additi

information
Presentation Topics Presentation Topics

z Backgroundz Program Objectivesz Program Functionsz Inspection Programsz Applicable RegulationszGuidance and Information

z Backgroundz Program Objectivesz Program Functionsz Inspection Programsz Applicable RegulationszGuidance and Information
BIMO Program Backgro

BIMO Program BackgroKnown as “BIMO”z 1975-1976 Congressional z Directed FDA to establish 

agency-wide program

z Encompass all operationa

& regulated products

z Authorized $16M & 606 FT

Known as “BIMO”

z 1975-1976 Congressional z Directed FDA to establish 

agency-wide program

z Encompass all operationa

& regulated products

z Authorized $16M & 606 FT
BIMO Program Backgro

BIMO Program BackgroA comprehensive, agency-w

program of on-site inspectdata audits designed to moaspects of the conduct and reporting of FDA-regulated research 

A comprehensive, agency-w

program of on-site inspectdata audits designed to moaspects of the conduct and reporting of FDA-regulated research
BIMO Program Backgro

BIMO Program BackgroThe BIMO program monitors

–

Sponsors/Contract Researc

Organizations (CROs)/Mon

– Institutional Review Boards –

Clinical Investigators (CIs)

–

Nonclinical Laboratories

The BIMO program monitors

–Sponsors/Contract Researc

Organizations (CROs)/Mon

– Institutional Review Boards – Clinical Investigators (CIs)– Nonclinical Laboratories
BIMO Program Objectiv

BIMO Program Objectivz Protect the rights, safety, a

welfare of human research 

z Assure the quality, reliabili

integrity of data collected

z Protect the rights, safety, a

welfare of human research 

z Assure the quality, reliabili

integrity of data collected
BIMO Program Functio

BIMO Program Functioz Audit clinical dataz Inspect ongoing clinical rez Inspect nonclinical laboratz Inspect IRBsz Educate and trainz Implement FDA’s Applicat

Integrity Policy

z Audit clinical dataz Inspect ongoing clinical resz Inspect nonclinical laboratoz Inspect IRBsz Educate and trainz Implement FDA’s Applicat

Integrity Policy
What may Prompt an Ins

of Device Research? 

What may Prompt an Insof Device Research?

z New Product or Indicationz New Technologyz Complaintsz History of non-compliancez Routine Surveillance

z New Product or Indicationz New Technologyz Complaintsz History of non-compliancez Routine Surveillance
BIMO Inspection Progra

BIMO Inspection Progrz Routine

– 

Surveillance

– 

Compliance follow-up

z Directed

– 

Data audits of device submissio

z For Cause

– Investigate problems– Investigate complaints

z Routine

– Surveillance– Compliance follow-up

z Directed

– Data audits of device submissio

z For Cause

– Investigate problems– Investigate complaints
BIMO Inspection Progra

BIMO Inspection ProgrInspection Classificationsz NAI –

No Action Indicated

z VAI –

Voluntary Action Ind

zOAI – Official Action Indica

Inspection Classifications

z NAI –

No Action Indicated

z VAI –

Voluntary Action Ind

zOAI – Official Action Indica
BIMO Compliance Prog

BIMO Compliance Progz Clinical Investigatorsz Sponsors, Contract Research 

Organizations, and Monitors

z Institutional Review Boardsz Good Laboratory Practices

www.fda.gov/ora/cpgm/default.h

z Clinical Investigatorsz Sponsors, Contract Research 

Organizations, and Monitors

z Institutional Review Boardsz Good Laboratory Practices

www.fda.gov/ora/cpgm/default.h
Clinical Investigator (CI

Clinical Investigator (CAn individual who actually c

clinical investigation, undeimmediate direction the tesis administered, dispensedused. 

An individual who actually co

clinical investigation, undeimmediate direction the tesis administered, dispensedused. 
Sponsor Sponsor

z Takes responsibility for an

a clinical investigation, but actually conduct the invest

z May be an individual, com

government agency, acadinstitution, private organiza

z Takes responsibility for an

a clinical investigation, but actually conduct the invest

z May be an individual, com

government agency, acadeinstitution, private organiza
Monitor Monitor

z Individual designated by a 

or contract research organoversee the progress of an investigation

z Must be qualified by trainin

experience to monitor the investigation

z Individual designated by a 

or contract research organoversee the progress of an investigation

z Must be qualified by trainin

experience to monitor the investigation
Contract Research Organizati

Contract Research Organizati

A person who assumes, as 

independent contractor witsponsor, one or more of thobligations of a sponsor 

A person who assumes, as 

independent contractor witsponsor, one or more of thobligations of a sponsor
Institutional Review Boar

Institutional Review BoarAny board, committee, or ot

formally designated by an institution to review, to appinitiation of, and conduct preview of, biomedical reseinvolving human subjects 

Any board, committee, or ot

formally designated by an institution to review, to appinitiation of, and conduct preview of, biomedical reseinvolving human subjects
Sponsor-Investigator (S

Sponsor-Investigator (SAn individual who both initia

actually conducts, alone oothers, an investigation, anwhose immediate direction investigational product is administered, dispensed, oThe obligations include boof a sponsor and an invest

An individual who both initia

actually conducts, alone oothers, an investigation, anwhose immediate direction investigational product is administered, dispensed, oThe obligations include boof a sponsor and an invest
Non-Clinical Laboratorie

Non-Clinical LaboratorieAnimal laboratories where p

clinical studies are conduc

Animal laboratories where p

clinical studies are conduc
FDA Regulations 

that apply to BIMO 

FDA Regulations that apply to BIMO

z 21 CFR 50: Protection of Hum

Subjects

z 21 CFR 54: Financial Disclosz 21 CFR 56: Institutional Revi

(IRB)

z 21 CFR 58: Good Laboratory 

for Non-Clinical Laboratory St(GLP)

z 21 CFR 50: Protection of Hum

Subjects

z 21 CFR 54: Financial Disclosz 21 CFR 56: Institutional Revi

(IRB)

z 21 CFR 58: Good Laboratory 

for Non-Clinical Laboratory St(GLP)
FDA Regulations 

that apply to BIMO 

FDA Regulations that apply to BIMO 

z 21 CFR 809: In Vitro Diag

Products (IVD)

z 21 CFR 812: Investigation

Exemption (IDE) 

z 21 CFR 809: In Vitro Diag

Products (IVD)

z 21 CFR 812: Investigation

Exemption (IDE) 
Guidance and Informat

Guidance and Informatz Computerized Systems Us

Clinical Investigations, Ma

z Protecting the Rights, Safe

Welfare of Study Subjects Supervisory ResponsibilitieInvestigators, May 2007

z Computerized Systems Us

Clinical Investigations, Ma

z Protecting the Rights, Safe

Welfare of Study Subjects Supervisory ResponsibilitieInvestigators, May 2007
Guidance and Informat

Guidance and Informatz The Review and Inspection of 

Premarket Approval Applicatiothe Bioresearch Monitoring PJanuary 2008

z Guidance for Sponsors, Clinic

Investigators, and IRBs –

Dat

Retention When Subjects Witfrom FDA-regulated clinical trOctober 2008

z The Review and Inspection of 

Premarket Approval Applicatiothe Bioresearch Monitoring PrJanuary 2008

z Guidance for Sponsors, Clinic

Investigators, and IRBs –

Dat

Retention When Subjects Witfrom FDA-regulated clinical trOctober 2008
Guidance and Informat

Guidance and Informatz Draft Guidance

– 

Protecting the Rights, Safety, aof Study Subjects – 

Supervisor

Responsibilities of Investigators 

z Information Sheets

– 

Frequently Asked Questions AbReview of Medical Devices 

– 

Significant and Non-significant Medical Device Studies 

z Draft Guidance

– Protecting the Rights, Safety, a

of Study Subjects – 

Supervisory 

Responsibilities of Investigators

z Information Sheets

– Frequently Asked Questions Ab

Review of Medical Devices

– Significant and Non-significant 

Medical Device Studies 
For More Information For More Information

z FDA Home Page www.fda.goz Center for Devices and Radio

Health www.fda.gov/cdrh/

z Device Advice 

www.fda.gov/cdrh/devadvice

z CDRH BIMO site 

www.fda.gov/cdrh/bimo/html

z FDA Home Page www.fda.goz Center for Devices and Radio

Health www.fda.gov/cdrh/

z Device Advice 

www.fda.gov/cdrh/devadvice

z CDRH BIMO site 

www.fda.gov/cdrh/bimo/html
For More Information For More Information

z FDA Good Clinical Practices 

www.fda.gov/oc/gcp/default.h

z Code of Federal Regulations 

Main Page http://www.accessdata.fda.godrh/cfdocs/cfcfr/cfrsearch.cfm

z FDA Consumer Magazine 

www.fda.gov/fdac/

z FDA Good Clinical Practices 

www.fda.gov/oc/gcp/default.h

z Code of Federal Regulations 

Main Page http://www.accessdata.fda.godrh/cfdocs/cfcfr/cfrsearch.cfm

z FDA Consumer Magazine 

www.fda.gov/fdac/
Summary Summary

zObjectives of the BIMO proz Specific roles in clinical triaz Four compliance programs z FDA regulations applicable 

BIMO

z Additional information

zObjectives of the BIMO proz Specific roles in clinical triaz Four compliance programs z FDA regulations applicable 

BIMO

z Additional information