FDA 2013 Clinical Investigator Training Course: Issues in Clinical Trials Des...MedicReS
FDA 2013 Clinical Investigator Training Course: Issues in Clinical Trials Designs for Devices
Owen Faris, Ph.D.,Deputy Director, Division of Cardiovascular Devices, Office of Device Evaluation, CDRH, FDA
Safety Monitoring and Reporting in Clinical Trials DIA Poster 2015KCR
How to get the plausible and precise safety data, maintaining the highest ethical standards
during clinical development?
KCR’s article presents critical points in safety monitoring and reporting at different stages of the clinical trial, as well the main difficulties faced by medical personnel and clinical team during their everyday practice.
In any work or process documents that are needed before initiation, Between or generally the end of the process just like in a clinical trial those “Documents which permit evaluation of the conduct of a trial and the quality of the data produced. It is given in the 8th section of the ICH-GCP.
FDA 2013 Clinical Investigator Training Course: Issues in Clinical Trials Des...MedicReS
FDA 2013 Clinical Investigator Training Course: Issues in Clinical Trials Designs for Devices
Owen Faris, Ph.D.,Deputy Director, Division of Cardiovascular Devices, Office of Device Evaluation, CDRH, FDA
Safety Monitoring and Reporting in Clinical Trials DIA Poster 2015KCR
How to get the plausible and precise safety data, maintaining the highest ethical standards
during clinical development?
KCR’s article presents critical points in safety monitoring and reporting at different stages of the clinical trial, as well the main difficulties faced by medical personnel and clinical team during their everyday practice.
In any work or process documents that are needed before initiation, Between or generally the end of the process just like in a clinical trial those “Documents which permit evaluation of the conduct of a trial and the quality of the data produced. It is given in the 8th section of the ICH-GCP.
Cure, how placebo works, placebo, placebo effect, What is the placebo effect, Mechanism of the placebo effect, How does the placebo effect works, How are placebos used
Basic introduction to clinical trials and the placebo effect. Definitions, examples and cartoons illustrating the subject. Ends with short info on informed consent.
Regulations in clinical research: obligations and responsibilities of investi...TrialJoin
Two of the most important individuals in a clinical trial are investigators and sponsors. However, being such a crucial part of a trial also brings many obligations and responsibilities. Although the sponsor is the one who initiates and finances a trial, the investigator is the person who conducts it. For this reason, most of the obligations and responsibilities fall on the investigator as the person accountable for everything that goes wrong in a trial. Learning these obligations and knowing how to follow them is a crucial practice that will ensure compliance in a clinical trial.
For this reason, we’ve decided to compose this material that will give you a basic outline of all the rules and regulations that investigators and sponsors should follow.
Regulations in Clinical Research: Obligations and Responsibilities of Investi...Anand Butani
Two of the most important individuals in a clinical trial are investigators and sponsors. However, being such a crucial part of a trial also brings many obligations and responsibilities. Although the sponsor is the one who initiates and finances a trial, the investigator is the person who conducts it. For this reason, most of the obligations and responsibilities fall on the investigator as the person accountable for everything that goes wrong in a trial. Learning these obligations and knowing how to follow them is a crucial practice that will ensure compliance in a clinical trial.
For this reason, we’ve decided to compose this material that will give you a basic outline of all the rules and regulations that investigators and sponsors should follow.
FDA Enforcement: What Every Clinical Director Should KnowMichael Swit
Half day tutorial presentation on key compliance concerns for those involved in clinical studies, with an emphasis on the key issues FDA examines and also a review of FDA's enforcement powers, ranging from warning letters to criminal prosecutions.
The slides explain 21 CFR Part 812. It includes all the guidelines to be followed by any manufacturer and investigator while manufacturing and investigating the safety, efficacy of the medical device.
Quorum Review IRB presented a live webinar in September 2014 covering the details of IRB review for medical device studies and their special considerations.
The United States has always been and remains to be the leading place
for the conduct of clinical trials. According to Clinicaltrials.gov, the largest
clinical trials registry, 32% of registered clinical trials were conducted in
the U.S. as of May 2022 (1). Factors such as the availability of qualified
healthcare professionals, high-quality infrastructure and facilities,
cutting-edge research, an efficient regulatory system, and a high
standard of ethics and participant protection make the U.S. the leading
country for clinical trials.
Clinical trials follow extensive preclinical research to test the safety and
efficacy of a new drug, medical device, or biological in humans. They are
usually divided into three phases: phases I, II, and III which are designed
to ascertain safety, pharmacokinetics, efficacy, dosage, and adverse
events. Figure 1 shows the typical route from discovery and preclinical
studies to the post-marketing phase (phase IV).Clinical trials represent the longest and most expensive step in bringing
drugs to the market and have the highest attrition rate, only 10% of drugs
that enter phase I trials are granted marketing approval. Therefore,
clinical trials should be conducted by experts that are
well-versed with all the regulations and guidelines in a particular region to
boost the chances of drug approval.
The United States Food and Drug Administration (US FDA) is the
regulatory body that approves and oversees the conduct of clinical trials
for drugs, medical devices, and biologicals that are intended to be
marketed in the U.S and is touted to have the most stringent standards
for drug approval. The primary role of the FDA is to protect public health
by ensuring that medicinal products and devices are safe and efficacious.
Therefore, it is necessary for sponsors/investigators or contract research
organizations (CRO) that are conducting clinical trials to be familiar with
regulations and guidances that govern the conduct of clinical trials.Conducting a clinical trial in the United States requires a deep understanding of the
regulations and guidelines set by the FDA. It is important to know what is needed for a
successful clinical trial, from selecting an appropriate study site to obtaining informed
consent from participants. Additionally, it is essential to understand the requirements for data
collection and analysis, as well as how to develop an effective protocol. Clinical trial services
in USA can provide guidance on all of these aspects and more, helping you ensure that your
clinical trial meets all necessary standards
Investigational new drug application must be submitted after discovering a new drug and before beginning of clinical trials. Here given a brief note on the topic.The topics included are types of IND, criteria for application, Information in IND application, resources for IND application, laws.regulations, policies and procedures, IND forms and instructions, IND content requirements and review of IND
MedicReS Conference 2017 Istanbul - Fostering Responsible Conduct of Research...MedicReS
Fostering Responsible Conduct of Research
MedicReSConference
May 5, 2017
Istanbul, Turkey
Adil E. Shamoo, Ph.D., CIP
University of Maryland School of Medicine
MedicReS Conference 2017 Istanbul - Ethical issues of secondary analysis of a...MedicReS
Ethical issues of secondary analysis of archived data
MedicReS Conference
May 4, 2017
Istanbul, Turkey
Adil E. Shamoo, Ph.D., CIP
University of Maryland School of Medicine
MedicReS Conference 2017 Istanbul - Integrity of Authorship in Research Publi...MedicReS
Integrity of Authorship in Research Publications
MedicReSConference
May 4, 2017
Istanbul, Turkey
Adil E. Shamoo, Ph.D., CIP
University of Maryland School of Medicine
MedicReS Winter School 2017 Vienna - Ethics of Cancer Trials - Adil E. ShamooMedicReS
A Comprehensive Introduction to the Ethical Issues at stake in the conduct of Cancer Research
Adil E. Shamoo, Ph.D.
University of Maryland School of Medicine
These simplified slides by Dr. Sidra Arshad present an overview of the non-respiratory functions of the respiratory tract.
Learning objectives:
1. Enlist the non-respiratory functions of the respiratory tract
2. Briefly explain how these functions are carried out
3. Discuss the significance of dead space
4. Differentiate between minute ventilation and alveolar ventilation
5. Describe the cough and sneeze reflexes
Study Resources:
1. Chapter 39, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 34, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 17, Human Physiology by Lauralee Sherwood, 9th edition
4. Non-respiratory functions of the lungs https://academic.oup.com/bjaed/article/13/3/98/278874
- Video recording of this lecture in English language: https://youtu.be/lK81BzxMqdo
- Video recording of this lecture in Arabic language: https://youtu.be/Ve4P0COk9OI
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
- Link to NephroTube website: www.NephroTube.com
- Link to NephroTube social media accounts: https://nephrotube.blogspot.com/p/join-nephrotube-on-social-media.html
Ozempic: Preoperative Management of Patients on GLP-1 Receptor Agonists Saeid Safari
Preoperative Management of Patients on GLP-1 Receptor Agonists like Ozempic and Semiglutide
ASA GUIDELINE
NYSORA Guideline
2 Case Reports of Gastric Ultrasound
Explore natural remedies for syphilis treatment in Singapore. Discover alternative therapies, herbal remedies, and lifestyle changes that may complement conventional treatments. Learn about holistic approaches to managing syphilis symptoms and supporting overall health.
Title: Sense of Taste
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the structure and function of taste buds.
Describe the relationship between the taste threshold and taste index of common substances.
Explain the chemical basis and signal transduction of taste perception for each type of primary taste sensation.
Recognize different abnormalities of taste perception and their causes.
Key Topics:
Significance of Taste Sensation:
Differentiation between pleasant and harmful food
Influence on behavior
Selection of food based on metabolic needs
Receptors of Taste:
Taste buds on the tongue
Influence of sense of smell, texture of food, and pain stimulation (e.g., by pepper)
Primary and Secondary Taste Sensations:
Primary taste sensations: Sweet, Sour, Salty, Bitter, Umami
Chemical basis and signal transduction mechanisms for each taste
Taste Threshold and Index:
Taste threshold values for Sweet (sucrose), Salty (NaCl), Sour (HCl), and Bitter (Quinine)
Taste index relationship: Inversely proportional to taste threshold
Taste Blindness:
Inability to taste certain substances, particularly thiourea compounds
Example: Phenylthiocarbamide
Structure and Function of Taste Buds:
Composition: Epithelial cells, Sustentacular/Supporting cells, Taste cells, Basal cells
Features: Taste pores, Taste hairs/microvilli, and Taste nerve fibers
Location of Taste Buds:
Found in papillae of the tongue (Fungiform, Circumvallate, Foliate)
Also present on the palate, tonsillar pillars, epiglottis, and proximal esophagus
Mechanism of Taste Stimulation:
Interaction of taste substances with receptors on microvilli
Signal transduction pathways for Umami, Sweet, Bitter, Sour, and Salty tastes
Taste Sensitivity and Adaptation:
Decrease in sensitivity with age
Rapid adaptation of taste sensation
Role of Saliva in Taste:
Dissolution of tastants to reach receptors
Washing away the stimulus
Taste Preferences and Aversions:
Mechanisms behind taste preference and aversion
Influence of receptors and neural pathways
Impact of Sensory Nerve Damage:
Degeneration of taste buds if the sensory nerve fiber is cut
Abnormalities of Taste Detection:
Conditions: Ageusia, Hypogeusia, Dysgeusia (parageusia)
Causes: Nerve damage, neurological disorders, infections, poor oral hygiene, adverse drug effects, deficiencies, aging, tobacco use, altered neurotransmitter levels
Neurotransmitters and Taste Threshold:
Effects of serotonin (5-HT) and norepinephrine (NE) on taste sensitivity
Supertasters:
25% of the population with heightened sensitivity to taste, especially bitterness
Increased number of fungiform papillae
New Drug Discovery and Development .....NEHA GUPTA
The "New Drug Discovery and Development" process involves the identification, design, testing, and manufacturing of novel pharmaceutical compounds with the aim of introducing new and improved treatments for various medical conditions. This comprehensive endeavor encompasses various stages, including target identification, preclinical studies, clinical trials, regulatory approval, and post-market surveillance. It involves multidisciplinary collaboration among scientists, researchers, clinicians, regulatory experts, and pharmaceutical companies to bring innovative therapies to market and address unmet medical needs.
Knee anatomy and clinical tests 2024.pdfvimalpl1234
This includes all relevant anatomy and clinical tests compiled from standard textbooks, Campbell,netter etc..It is comprehensive and best suited for orthopaedicians and orthopaedic residents.
Basavarajeeyam is an important text for ayurvedic physician belonging to andhra pradehs. It is a popular compendium in various parts of our country as well as in andhra pradesh. The content of the text was presented in sanskrit and telugu language (Bilingual). One of the most famous book in ayurvedic pharmaceutics and therapeutics. This book contains 25 chapters called as prakaranas. Many rasaoushadis were explained, pioneer of dhatu druti, nadi pareeksha, mutra pareeksha etc. Belongs to the period of 15-16 century. New diseases like upadamsha, phiranga rogas are explained.
Basavarajeeyam - Ayurvedic heritage book of Andhra pradesh
FDA 2013 Clinical Investigator Training Course: Ensuring the Safety of Clinical Trials: AE Reporting, DSMBs, IRBs (CDER)
1. 1
Dr. Mathew T. Thomas
Acting Director
Division of Safety Compliance
Office of Scientific Investigations
U.S. FDA – CDER – Office of Compliance
Telephone: 301-796-8684
Ensuring the Safety of Clinical Trials
(Investigations)
2. 2
DISCLAIMER
My statements and advice do not bind or otherwise
obligate or commit the agency to the views
expressed
21 CFR 10.85(k) “A statement made or advice provided by an FDA employee constitutes an advisory
opinion only if it is issued in writing under this section. A statement or advice given by an FDA employee
orally, or given in writing but not under this section or Sec. 10.90, is an informal communication that
represents the best judgment of that employee at that time but does not constitute an advisory opinion,
does not necessarily represent the formal position of FDA, and does not bind or otherwise obligate or
commit the agency to the views expressed.”
3. 3
Outline
I. Purpose of this Presentation
II. A Brief Review of the Clinical Investigator
Responsibilities in Clinical Investigations
- Adverse Event Reporting
- Role of a DSMB
- Institutional Review Boards
III. Means of Oversight of a Clinical Investigation
IV. Helpful Hints for Conducting a Quality Clinical
Investigation
V. Pertinent References
4. 4
Purpose of Presentation
• To make clinical investigators aware of important responsibilities to
adequately conduct clinical investigations
– Importance of collecting and reporting quality data
– Importance of adhering to U.S. regulatory requirements and to
GCPs
• This knowledge is important to ensure:
– Results of an investigation are reliable and valid
– Rights, safety and welfare of human subjects are protected
– Investigation is conducted in compliance with regulatory
requirements
5. 5
To understand, collect and report Quality Data
Data that are Attributable, Legible, Contemporaneous,
Original, Accurate (ALCOA), complete, and current
To understand and conduct a Quality Investigation
• An investigation that has quality data
• Conducted in accordance with the IRB approved
protocol
• Conducted in accordance with all applicable regulatory
requirements
Quality Investigations lead to Quality Data
Purpose of Presentation (continued)
6. 6
Understand what Good Clinical Practice (GCP) is…
• Principles/guidelines for conducting a clinical investigation
• Ethical and scientific quality standards for designing, conducting,
performing, monitoring, auditing, recording, analyzing and
reporting clinical investigations*
• International Conference on Harmonization - E6 Good Clinical
Practice Guideline
• GCP is also defined by FDA regulations under 21 CFR 312.120
*http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulator
yInformation/Guidances/ucm073122.pdf
Purpose of Presentation (continued)
7. 7
Why Conduct Clinical Investigations as per
Applicable Regulatory Requirements?
• To provide greater assurance that the conduct of the
investigation meets acceptable standards and guidelines
• To provide greater assurance of data quality and human
subject protection in clinical studies
• To reduce the likelihood of encountering significant non-
compliance, data-discrepancy issues, and regulatory actions
• To enhance data reliability and acceptability upon which
regulatory approval decisions are made
8. 8
When Clinical Trials are not Conducted as
per Applicable Regulatory Requirements
• FDA can reject data from that clinical site and/or the
entire marketing application
• Subjects in clinical investigations are exposed to
unnecessary risks and hardships
• FDA can take regulatory action against the clinical
investigator, e.g., issue WL or disqualify the Clinical
Investigator
9. 9
A Note About Sponsor-Investigator
An individual who both initiates
and conducts a clinical investigation
Dual Responsibilities
Dual Role
21 CFR § 312.3
10. 10
Sponsor
• A person who takes responsibility for and initiates
a clinical investigation
• May be an individual or pharmaceutical company,
governmental agency, academic institution,
private organization, or other organization
• The sponsor does not actually conduct the
investigation unless the sponsor is a sponsor-
investigator
21 CFR § 312.3
11. 11
Investigator Responsibilities
• Protecting the rights,
safety and welfare of
subjects in the clinical
investigation
• Conducting the clinical
investigation according to
signed statement of
investigator (Form 1572),
investigational plan and
applicable regulations
21 CFR § 312.60
13. 13
Form FDA-1572 includes:
• Name and address of the clinical investigator
• Name and code number of any protocol(s)
• Name and address of research facility(ies)
and any clinical labs
• Name and address of the responsible IRB
• Names of sub-investigators
• Signed commitment by the investigator
Statement of Investigator
21 CFR § 312.53
14. 14
A Signed Commitment by the Investigator to:
• Conduct the investigation according to the protocol, and make changes
only after notifying sponsor, except to protect the safety, welfare and
rights of subjects
• Personally conduct or supervise the investigation
• Inform subjects that the test product is being used for investigational
purposes and ensure requirements for informed consent and IRB
review and approval are met
• Read and understand the Investigator’s Brochure, including potential
risks and side effects of the drug
• Report to the sponsor adverse experiences that occur during the
investigation
Statement of Investigator (continued)
21 CFR § 312.53
15. 15
• Required to submit all reports to the sponsor of the investigation. The sponsor
is required under 312.33 to submit Annual Reports on the progress of the
clinical investigation.
• Safety Reports:
• Required to immediately report to the sponsor any serious adverse event, whether
or not considered drug related, including those listed in the protocol or investigator
brochure and must include an assessment of whether there is a reasonable
possibility that the drug caused the event.
• Study endpoints that are serious adverse events (e.g., all-cause mortality) must be
reported in accordance with the protocol unless there is evidence suggesting a
causal relationship between the drug and the event (e.g., death from anaphylaxis).
In that case, the investigator must immediately report the event to the sponsor.
• The investigator must record non-serious adverse events and report them to the
sponsor according to the timetable for reporting specified in the protocol.
• Final Report:
• An investigator shall provide the sponsor with an adequate report shortly after
completion of the investigator's participation in the investigation.
• Required to report to the IRB all unanticipated problems involving risks
to human subjects or others.
Investigator Safety Reports
21 CFR § 312.64 and 312.66
16. 16
• Adverse Event (AE or Adverse Experience) = Any untoward medical occurrence associated
with the use of a drug in humans, whether or not considered drug related
• Sponsors and Sponsor-Investigators are required to submit written IND Safety Reports to
FDA and all participating clinical investigators
• IND Safety Reports are submitted on FDA Form 3500A, electronic, or narrative format
• Sponsor must report as soon as possible but no later than 15 calendar days any potential
serious risks from clinical trials, or other sources from the use of the test product including
any:
Serious and unexpected suspected adverse reaction
Findings from other studies that suggest a significant risk in humans exposed to
the drug
Findings from animal or in vitro testing that suggest a significant risk in humans
exposed to the drug
Increased rate of occurrence of serious suspected adverse reactions over that
listed in the protocol or investigator brochure
• Sponsors are to submit reports of any unexpected fatal or life threatening suspected
adverse reaction associated with use of the drug by telephone or facsimile as soon as
possible but no later than 7 calendar days after the initial receipt of the information
Sponsor’s IND Safety Reports
21 CFR § 312.32
17. 17
A Signed Commitment by the Investigator to:
• Assure that those assisting in the trial are informed of their obligations in
meeting these commitments
• Maintain adequate and accurate records
• Obtain initial and continuing review and approval from an IRB that is in
compliance with the regulatory requirements listed under 21 CFR Part 56
• Promptly report to the IRB all changes in the research and all
unanticipated problems involving risk to subjects or others
• Not make changes in the research without IRB approval except to
eliminate immediate hazards to human subjects
• Comply with all other regulatory requirements regarding obligations of a
clinical investigator
Statement of Investigator (continued)
21 CFR § 312.53
18. 18
Investigator Responsibilities (continued)
• Obtain IRB approval prior to enrolling any subjects
• Obtain and document informed consent signed and dated by
subject or legally authorized representative (LAR)
• Follow the study protocol and investigational plan
• Ensure that changes to the protocol are reported to the sponsor and
approved by the IRB prior to initiating the change
21 CFR §§ 50, 56, 312.60, 312.66
19. 19
Investigator Responsibilities (continued)
• Control the investigational products
• Use test products only in/on subjects enrolled in
the clinical investigation
• Ensure adverse effects/events (AEs) are
appropriately documented and reported
• Maintain adequate clinical investigational records
and reports
• Ensure that all investigational records and reports
are available for FDA inspection
21 CFR §§ 312.61, 312.62, 312.64 & 312.68
20. 20
Means of Oversight of a Clinical
Investigation
• Investigator’s study oversight and supervision
• IRB’s initial and continuing reviews
• Sponsor/CRO monitoring and audits
• Audits by US and International Regulatory Agencies
• Adjudication Review Committees
• Data Safety Monitoring Board (DSMB)
21. 21
Regulatory Monitoring vs. DSMB
DSMB = Data Safety Monitoring Board,
which performs clinical monitoring of an
ongoing investigation
Please Note:
Regulatory Monitoring ≠ Clinical Monitoring
22. 22
Data Safety Monitoring Board
• A group that periodically reviews and evaluates
accumulated data from a clinical investigation
for:
– Subject safety
– Study conduct and progress, and
– As necessary, efficacy
• They make recommendations to the sponsor
regarding the continuation, modification, or
termination of the trial
http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM127073.pdf
23. 23
• Keep ALL files organized at all times
• Keep all source documents and study related materials
• Keep ALL correspondence:
– Sponsor, IRB, monitors, study subject letters, faxes, e-mails,
memos and phone contacts
• Know your IRB’s requirements
• Know the sponsor’s/IRB’s adverse event reporting requirements
• Know the protocol:
– Inclusion/exclusion criteria, study windows, study procedures
• Know each study staff member’s roles and responsibilities:
– The clinical investigator is ultimately responsible
Reminder for Personnel Involved
in a Clinical Investigation
24. 24
• Sponsor responsibilities may be transferred to a Contract Research
Organization (CRO)
• CRO assumes the regulatory responsibility and obligations for
transferred tasks that are specified in writing
• Responsibilities that are not contracted in writing will remain the
obligation of the sponsor
• Keep all test article accountability records current, complete and
accurate:
– Shipping receipts, enrollment logs, dispensing logs
• Written procedures are recommended:
– SOPs, Quality Policy, Training procedures, Job descriptions, etc.
• Have a Preventive and Corrective Action Plan if problems arise
Reminder for Personnel Involved
in a Clinical Investigation (cont.)
25. 25
• It is important to capture the highest quality
data possible to ensure that the
investigational product
• is reasonably safe
• is reasonably effective
Conclusion
27. 27
REGULATIONS
(All Products)
• 21 CFR 50: Protection of Human Subjects
• 21 CFR 54: Financial Disclosure
• 21 CFR 56: Institutional Review Boards
• 21 CFR 58: Good Laboratory Practice for Non-Clinical
laboratory Studies
28. 28
REGULATIONS
(Drugs and Biologics)
• 21 CFR 312: Investigational New Drug Application (IND)
• 21 CFR 314: New Drug Application (NDA)
• 21 CFR 316: Orphan Drugs
• 21 CFR 320: Bioavailability and Bioequivalence
Requirements
• 21 CFR 601: Biological Licensing (BLA)
29. 29
For More Information
• FDA Home Page
www.fda.gov
• FDA Good Clinical Practices
http://www.fda.gov/oc/gcp/default.htm
• Code of Federal Regulations (CFR)
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm
• Center for Drug Evaluation and Research (CDER) Office of Scientific
Investigations (OSI)
http://www.fda.gov/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cder/ucm090085.htm
• Center for Biologics Evaluation and Research (CBER) Division of
Inspections and Surveillance
http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/ComplianceAct
ivities/ProductSurveillance/default.htm
• Center for Devices and Radiological Health (CDRH) Bioresearch
Monitoring (BiMo)
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/BioresearchMonitoring/def
ault.htm