bioresearch monitoring pragram

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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

2. 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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3.  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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4. 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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5. 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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6. 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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7. BIMO Inspection Programs
Routine
– Surveillance
– Compliance follow-up
 Directed
– Data audits of device submissions
 For Cause
– Investigate problems
– Investigate complaints 7

8. 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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9. BIMO Compliance Programs
 Clinical Investigators (CI)
 Sponsors,
 Contract Research Organizations, and
Monitors
 Institutional Review Boards (IRB)
 Good Laboratory Practices (GLP)
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10. 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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11. 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
organization
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12. 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 rhythms
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13. 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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14. 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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15. 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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16. Non-Clinical Laboratories
Animal laboratories where pre-clinical
studies are conducted
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17. 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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18. 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

19. 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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