The document provides an agenda for a presentation on the differences between clinical trials for drugs and devices, including an overview of drugs and devices, determining the need for a clinical trial, regulatory overview, clinical trial similarities, and clinical trial differences. It outlines topics such as risk classifications for devices, investigator responsibilities, and agreements between sponsors and investigators. The presentation aims to highlight both the similarities and differences in conducting clinical research on drugs versus medical devices.
Overview of FDA requirements for clinical studies as well as privacy issues, including impact of HIPAA; plus practical considerations in developing clinical studies.
Overview of FDA requirements for clinical studies as well as privacy issues, including impact of HIPAA; plus practical considerations in developing clinical studies.
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.
Presentation working on clinical trialsSarah Henter
Working on Clinical Trials – Getting started
Very few clinical trials are conducted only in one country; many are available in a variety of different sites in different places, so the translation and linguistic adaptation for different target cultures and languages becomes more important – but it’s not easy to find professionals who specialize in this specific field. With my presentation I hope to provide an overview of what makes the linguistic work on clinical trials so special, what kind of texts and target audiences there are and what knowledge linguists need to acquire in order to efficiently work in this area. This is especially interesting for translators who already specialize in the medical field, but also for linguists interested in legal, business, marketing and related field who would like to add an interesting niche with high demand to their specialization.
The presentation aims to be an introduction to the characteristics and requirements of the linguistic work on texts related to clinical trials. It not only wants to give a brief overview of how clinical trials work and who the stakeholders are, but also underline the skills and knowledge set linguists who would like to further specialize in this field should acquire. It also provides them with the necessary resources to get them started. The main topics are as follows:
• Introduction to clinical trials (what are they; how do they work; who is implied)
• Types of documents used in clinical trials (medical [specialist facing/ patient facing]; legal; marketing, etc.)
• Types of audiences (doctors/investigators/healthcare providers; patients/ other laymen such as healthy subjects/ partners/ legal representatives/ parents, etc.; ECs; CROs…)
• What skills do linguists need to work in this field?
• How to acquire that knowledge?
- Where to find glossaries/ templates/ further information
- MOOCs to take to get you started
- Books you should have read
- Other handy resources
FDA 2013 Clinical Investigator Training Course Preparing an IND Application: ...MedicReS
FDA 2013 Clinical Investigator Training Course Preparing an IND Application: Preclinical Considerations for Cell and Gene Therapy Products
Patrick Au, Ph.D., (CBER)
FDA 2013 Clinical Investigator Training Course: Preparing an IND Application:...MedicReS
FDA 2013 Clinical Investigator Training Course: Preparing an IND Application: Clinical Considerations for Cell and Gene Therapy Products
Rachel Witten, M.D., (CBER)
21CFR 320- BIO AVAILABILITY AND BIO EQUIVALENCE REQUIREMENTSPallavi Christeen
this presentation describes briefly about Bioavailability and Bioequivalence requirements as per US FDA Code of Federal Regulations under title 21 and chapter 320
CLINICAL RESEARCH IS ONE WHICH MADE POSSIBLE , ORAGAN TRANSPLANT, MANAGE OF DIBETIS, ADDED YEAR OF AIDS PATIENT.
HOW WELL NEW APPROCHES AND WORK IN PEOPLE.
THE APPROACHES CAN BE MEDICAL, BEHAVIORAL, OR MANAGEMENT.
EACH STUDY ANSWER SCIENTIFIC QUESTION.
GENERAL INTRODUCTION OF CLINICAL RESEARCH
KEY POINTS AND CONCEPTUAL DEFINATION
DRUG DISCOVERY PROCESS
SOURCES OF DRUG DISCOVERY
PRECLINICAL STUDY
FOR MORE RELATED QUERIES CONTACT US ON- 9028839789
FOR ENROLLMENT IN NEXT BATCH CONTACT ON ABOVE MENTIONED NUMBER
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.
Presentation working on clinical trialsSarah Henter
Working on Clinical Trials – Getting started
Very few clinical trials are conducted only in one country; many are available in a variety of different sites in different places, so the translation and linguistic adaptation for different target cultures and languages becomes more important – but it’s not easy to find professionals who specialize in this specific field. With my presentation I hope to provide an overview of what makes the linguistic work on clinical trials so special, what kind of texts and target audiences there are and what knowledge linguists need to acquire in order to efficiently work in this area. This is especially interesting for translators who already specialize in the medical field, but also for linguists interested in legal, business, marketing and related field who would like to add an interesting niche with high demand to their specialization.
The presentation aims to be an introduction to the characteristics and requirements of the linguistic work on texts related to clinical trials. It not only wants to give a brief overview of how clinical trials work and who the stakeholders are, but also underline the skills and knowledge set linguists who would like to further specialize in this field should acquire. It also provides them with the necessary resources to get them started. The main topics are as follows:
• Introduction to clinical trials (what are they; how do they work; who is implied)
• Types of documents used in clinical trials (medical [specialist facing/ patient facing]; legal; marketing, etc.)
• Types of audiences (doctors/investigators/healthcare providers; patients/ other laymen such as healthy subjects/ partners/ legal representatives/ parents, etc.; ECs; CROs…)
• What skills do linguists need to work in this field?
• How to acquire that knowledge?
- Where to find glossaries/ templates/ further information
- MOOCs to take to get you started
- Books you should have read
- Other handy resources
FDA 2013 Clinical Investigator Training Course Preparing an IND Application: ...MedicReS
FDA 2013 Clinical Investigator Training Course Preparing an IND Application: Preclinical Considerations for Cell and Gene Therapy Products
Patrick Au, Ph.D., (CBER)
FDA 2013 Clinical Investigator Training Course: Preparing an IND Application:...MedicReS
FDA 2013 Clinical Investigator Training Course: Preparing an IND Application: Clinical Considerations for Cell and Gene Therapy Products
Rachel Witten, M.D., (CBER)
21CFR 320- BIO AVAILABILITY AND BIO EQUIVALENCE REQUIREMENTSPallavi Christeen
this presentation describes briefly about Bioavailability and Bioequivalence requirements as per US FDA Code of Federal Regulations under title 21 and chapter 320
CLINICAL RESEARCH IS ONE WHICH MADE POSSIBLE , ORAGAN TRANSPLANT, MANAGE OF DIBETIS, ADDED YEAR OF AIDS PATIENT.
HOW WELL NEW APPROCHES AND WORK IN PEOPLE.
THE APPROACHES CAN BE MEDICAL, BEHAVIORAL, OR MANAGEMENT.
EACH STUDY ANSWER SCIENTIFIC QUESTION.
GENERAL INTRODUCTION OF CLINICAL RESEARCH
KEY POINTS AND CONCEPTUAL DEFINATION
DRUG DISCOVERY PROCESS
SOURCES OF DRUG DISCOVERY
PRECLINICAL STUDY
FOR MORE RELATED QUERIES CONTACT US ON- 9028839789
FOR ENROLLMENT IN NEXT BATCH CONTACT ON ABOVE MENTIONED NUMBER
Nydelig oppskrift på pannekaker / pannekakerøre. Opskriften skal være relativt enkel å gjennomføre.
For mer informasjon og detaljerte instrukser besøk:
http://enkeloppskrift.com/oppskrift-pannekaker/
Blue Berry Asia leading brands in Asian Market Strive to lead in Home Décor, Modular Kitchen, Built in Oven, Cook Top, Appliances, Cook Ware, Table Ware, BMW Slow Juicer, Air Purifier, Water Purifier, Crockery, Vacuum Cleaners, Personal Care, Fashion Garments,Fashion Accessories, Cosmetic, Skin Care, Anti Aging Cream, Relax Cream, Hair Care,Beauty Care, Cosmetics, Beauty Devices, Permanent Hair Removal, Handicrafts, Jewellery,Hand made Products
Regulatory oversight of genetic testing in Canada: Health Canada perspectiveMaRS Discovery District
Speaker: Patrice Sarrazin, PhD, Senior Scientific Evaluator, In Vitro Diagnostic Devices, Medical Devices Bureau, Therapeutic Product Directorate, Health Canada. Patrice discusses Health Canada's perspective on genetic testing as well as policy and regulation in Canada.
Part of Dx2010, a workshop at MaRS focused on best practices and regulatory considerations for developing gene-based diagnostic and prognostic tests.
CFTCC
2015 Learning about the IND/IDE Process and Reimbursements for New Drugs and Devices
Erika Segear Johnson, PhD, RAC
Regulatory Affairs Scientist
Duke Translational Medicine Institute
Introduces the basics of filing an Investigational Device Exeption (IDE) Application with the FDA
In-vitro diagnostic regulation overview as per FDA , including in-vitro defination , classification , examples , general control, special control , pre market notification , DeNovo classification , PMA , 510k or premarket notification , risk based classification
USFDA 510k for In-Vitro Diagnostic Devices.pptxinfo714590
Secure USFDA approval for In-Vitro Diagnostic Devices effortlessly. Your pathway to compliance and market success starts here! In the United States, In-Vitro Diagnostic devices require regulatory approval or clearance from the U.S. Food and Drug Administration before they can be legally marketed and sold. The specific regulatory pathway depends on the classification of the IVD device.
https://mavenprofserv.us/usfda-510k-for-in-vitro-diagnostic-devices/
Clinical trials that are needed for efficacy & safety evidence of Medical devices include feasibility (pilot) and Pivotal trials. An extended battery of preclinical trials are also needed for high risk devices.
A guideline on medical devices designed internationally for harmonization.
As the site access is unavailable have managed the data for easy access of the details for the Regulatory affairs aspirants of Masters of Pharmacy
Virtual Drug Development in Southern California: A Pre-Clinical Focus -Presen...mwright1
BIOCOM CRO event May 2013: Being an early stage virtual company is no easy task. Managing resources and timelines while minimizing costs are the new normal for successful virtual companies. This two hour event and panel discussion hosted by Explora Biolabs and MPI Research will explore successful preclinical drug development in a virtual setting. Explora BioLabs will discuss selecting a drug candidate using early biology/efficacy models as well as best practices for screening and partnering with a CRO to streamline your candidate selection in a resource constrained environment. Building on that discussion, MPI Research will describe how to advance a compound from early GLP tox and safety testing into phase 1 while utilizing successful partnerships.
Joining the presenters for a follow-on panel discussion will be:
David Johnson, Director of DMPK, MicroConstants, Inc.
Richard Lin, CEO, Explora Biolabs
Greg Ruppert, Sr. Study Director and Director of Sales, MPI Research
Jennifer Spinella, Vice President, Regulatory Affairs & Quality Assurance, Rare Disease Therapeutics
Presentation by MPI Research: Virtual Drug Development in Southern CaliforniaBIOCOMCRO
BIOCOM CRO event May 2013: Being an early stage virtual company is no easy task. Managing resources and timelines while minimizing costs are the new normal for successful virtual companies. This two hour event and panel discussion hosted by Explora Biolabs and MPI Research will explore successful preclinical drug development in a virtual setting. Explora BioLabs will discuss selecting a drug candidate using early biology/efficacy models as well as best practices for screening and partnering with a CRO to streamline your candidate selection in a resource constrained environment. Building on that discussion, MPI Research will describe how to advance a compound from early GLP tox and safety testing into phase 1 while utilizing successful partnerships.
Joining the presenters for a follow-on panel discussion will be:
David Johnson, Director of DMPK, MicroConstants, Inc.
Richard Lin, CEO, Explora Biolabs
Greg Ruppert, Sr. Study Director and Director of Sales, MPI Research
Jennifer Spinella, Vice President, Regulatory Affairs & Quality Assurance, Rare Disease Therapeutics
Visit www.biocom.org or www.biocomcro.org for more information or call 858.455.0300 to learn about BIOCOM's CRO Initiative
Medical Device FDA Regulations and Classifications infographicKathleen Murray
Infographic describing how the FDA classifies and regulates medical devices from life saving and sustaining devices to medical devices you use every day
Similar to Sandra Maddock & Brandy Smith BioEnterprise Presentation 9.6.12 (20)
The prostate is an exocrine gland of the male mammalian reproductive system
It is a walnut-sized gland that forms part of the male reproductive system and is located in front of the rectum and just below the urinary bladder
Function is to store and secrete a clear, slightly alkaline fluid that constitutes 10-30% of the volume of the seminal fluid that along with the spermatozoa, constitutes semen
A healthy human prostate measures (4cm-vertical, by 3cm-horizontal, 2cm ant-post ).
It surrounds the urethra just below the urinary bladder. It has anterior, median, posterior and two lateral lobes
It’s work is regulated by androgens which are responsible for male sex characteristics
Generalised disease of the prostate due to hormonal derangement which leads to non malignant enlargement of the gland (increase in the number of epithelial cells and stromal tissue)to cause compression of the urethra leading to symptoms (LUTS
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
Pulmonary Thromboembolism - etilogy, types, medical- Surgical and nursing man...VarunMahajani
Disruption of blood supply to lung alveoli due to blockage of one or more pulmonary blood vessels is called as Pulmonary thromboembolism. In this presentation we will discuss its causes, types and its management in depth.
Report Back from SGO 2024: What’s the Latest in Cervical Cancer?bkling
Are you curious about what’s new in cervical cancer research or unsure what the findings mean? Join Dr. Emily Ko, a gynecologic oncologist at Penn Medicine, to learn about the latest updates from the Society of Gynecologic Oncology (SGO) 2024 Annual Meeting on Women’s Cancer. Dr. Ko will discuss what the research presented at the conference means for you and answer your questions about the new developments.
Lung Cancer: Artificial Intelligence, Synergetics, Complex System Analysis, S...Oleg Kshivets
RESULTS: Overall life span (LS) was 2252.1±1742.5 days and cumulative 5-year survival (5YS) reached 73.2%, 10 years – 64.8%, 20 years – 42.5%. 513 LCP lived more than 5 years (LS=3124.6±1525.6 days), 148 LCP – more than 10 years (LS=5054.4±1504.1 days).199 LCP died because of LC (LS=562.7±374.5 days). 5YS of LCP after bi/lobectomies was significantly superior in comparison with LCP after pneumonectomies (78.1% vs.63.7%, P=0.00001 by log-rank test). AT significantly improved 5YS (66.3% vs. 34.8%) (P=0.00000 by log-rank test) only for LCP with N1-2. Cox modeling displayed that 5YS of LCP significantly depended on: phase transition (PT) early-invasive LC in terms of synergetics, PT N0—N12, cell ratio factors (ratio between cancer cells- CC and blood cells subpopulations), G1-3, histology, glucose, AT, blood cell circuit, prothrombin index, heparin tolerance, recalcification time (P=0.000-0.038). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and PT early-invasive LC (rank=1), PT N0—N12 (rank=2), thrombocytes/CC (3), erythrocytes/CC (4), eosinophils/CC (5), healthy cells/CC (6), lymphocytes/CC (7), segmented neutrophils/CC (8), stick neutrophils/CC (9), monocytes/CC (10); leucocytes/CC (11). Correct prediction of 5YS was 100% by neural networks computing (area under ROC curve=1.0; error=0.0).
CONCLUSIONS: 5YS of LCP after radical procedures significantly depended on: 1) PT early-invasive cancer; 2) PT N0--N12; 3) cell ratio factors; 4) blood cell circuit; 5) biochemical factors; 6) hemostasis system; 7) AT; 8) LC characteristics; 9) LC cell dynamics; 10) surgery type: lobectomy/pneumonectomy; 11) anthropometric data. Optimal diagnosis and treatment strategies for LC are: 1) screening and early detection of LC; 2) availability of experienced thoracic surgeons because of complexity of radical procedures; 3) aggressive en block surgery and adequate lymph node dissection for completeness; 4) precise prediction; 5) adjuvant chemoimmunoradiotherapy for LCP with unfavorable prognosis.
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
ARTIFICIAL INTELLIGENCE IN HEALTHCARE.pdfAnujkumaranit
Artificial intelligence (AI) refers to the simulation of human intelligence processes by machines, especially computer systems. It encompasses tasks such as learning, reasoning, problem-solving, perception, and language understanding. AI technologies are revolutionizing various fields, from healthcare to finance, by enabling machines to perform tasks that typically require human intelligence.
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Sandra Maddock & Brandy Smith BioEnterprise Presentation 9.6.12
1. The Difference is
in the Details
Drugs vs.
Devices
Presented by:
Brandy Smith
Sandra Maddock
We have studied clinical research and regulatory compliance
issues since 1999.
2. Agenda
An Overview of Drugs and Devices
Determining the Need for a Clinical Trial
Regulatory Overview
Clinical Trial Similarities
Clinical Trial Differences
FAIR Shake™- The Regulations
3. Agenda
An Overview of Drugs and Devices
Determining the Need for a Clinical Trial
Regulatory Overview
Clinical Trial Similarities
Clinical Trial Differences
FAIR Shake™- The Regulations
4. Overview of Drugs and Devices
Drugs
Articles recognized in the official US
Pharmacopoeia, official Homoeopathic
Pharmacopoeia of the US, or official National
Formulary
• intended for use in the
diagnosis, cure, mitigation, treatment, or prevention
of disease
• intended to affect the structure of any function of
the body
(FDC Act, Section 201)
5. Overview of Drugs and Devices
Devices
An
instrument, apparatus, implement, machine, contrivanc
e, implant, in vitro reagent, or other similar or related
article… which is –
• intended for use in the diagnosis of disease… in
cure, mitigation, treatment, or prevention of disease
• intended to affect the structure of any function of the
body… not achieved through chemical action… or being
metabolized
(FDC Act, Section 201)
6. Overview of Drugs and Devices
Device classifications
Class Description
Class I Least risky, general controls adequate; no clinical
trial needed
Class II Intermediate risk, special controls needed (510k)
Class III Substantial risk devices, pre-market approval
needed (IDE)
7. Drugs Devices
Chemical/ metabolic action Not metabolized
Distributed systemically Acts locally
May impact metabolism of other
Effects structure
drugs
Larger number of study subjects Smaller number of study subjects
needed to identify side effects needed
Clinical trial needs are based on
Clinical Trial Always Required risk classification of device
8. Agenda
An Overview of Drugs and Devices
Determining the Need for a Clinical Trial
Regulatory Overview
Clinical Trial Similarities
Clinical Trial Differences
FAIR Shake™- The Regulations
9. Determining the Need for a Clinical
Trial
• In situations of a drug, a clinical trial will always be
required
• However, not all devices will need to undergo a clinical
trial
• The determination of whether or not a device clinical
trial is required is based on a risk stratification
10. Determining the Need for a Clinical
Trial
Drugs Devices
All Drugs require Assess Risk
Clinical Trials Classification
21 CFR 312 Intermediate Risk Substantial Risk
“IND”
Clinical trial MAY be Clinical Trial
required Required
11. Determining the Need for a Clinical
Trial
Devices
Assess Risk
Classification
Intermediate Risk Substantial Risk
Clinical trial MAY be Clinical Trial
required Required
12. Determining the Need for a Clinical
Trial
Risk Stratification
Class Description Risk Classification
Class I Least risky, general controls Minima Intermediat Substantial
}
adequate; no clinical trial needed l Risk e Risk Risk
Class II Intermediate risk, special controls
needed (510k)
Class III Substantial risk devices, pre-market No MAY REQUIRES
approval needed (IDE) Clinical Require Clinical
Trial Clinical Trial
Required Trial
13. Determining the Need for a Clinical
Trial
Risk Stratification
Class Description Risk Classification
Class I Least risky, general controls Minima Intermediat Substantial
}
adequate; no clinical trial needed l Risk e Risk Risk
Class II Intermediate risk, special controls
needed (510k)
Class III Substantial risk devices, pre-market No MAY REQUIRES
approval needed (IDE) Clinical Require Clinical
Trial Clinical Trial
Required Trial
14. Determining the Need for a Clinical
Trial
Risk Stratification
Devices
Drugs
Assess Risk
Classification
All Drugs require
Clinical Trials
Intermediate Risk Substantial Risk
21 CFR 312
“IND”
Clinical trial MAY Clinical Trial
be required Required
15. Determining the Need for a Clinical
Trial
Risk Stratification
Drugs
All Drugs require *Clinical Trials Always
Clinical Trials
Required for New Drugs*
21 CFR 312
“IND”
16. Clinical Trials
Drugs
Phase Purpose
Phase I Normal healthy volunteers
Determine metabolism and pharmacologic actions
Aim= safety and tolerance
Phase II Patients with the disease or condition
Small Sample
Aim= safety and effectiveness
Phase III Patients with the disease or condition
LARGER population
Aim= safety and effectiveness
Phase IV Post approval studies
Obtain additional information regarding risks, benefits, and
optimal use
17. Clinical Trials
Devices
Study Purpose
Although there are “phases” in device research, they are not as delineated as
drugs
Pilot May conduct pilot study (strategic decision or FDA request)
Single-center or small number of multi-center sites
Small number of subjects
Safety and tolerance
Pivotal Larger number of subjects
Larger number of sites
Safety and effectiveness
Continued During PMA review of pivotal data, the FDA may grant
Access continued use of the device and allow more subjects to be
enrolled
Post Market Strategic decision or FDA’s request
Method to collect long-term data
18. Clinical Trials
Drugs and Devices
Feature Drug Device
Rate of technology change Low High
Influence of physician technique Low High
Population size Large Small
Able to visualize performance Low High
Ability to blind treatments Easy Difficult
Use of randomization High Low
Phases Clear Less Clear
(pilot/pivot
al)
19. Agenda
An Overview of Drugs and Devices
Determining the Need for a Clinical Trial
Regulatory Overview
Clinical Trial Similarities
Clinical Trial Differences
FAIR Shake™- The Regulations
21. Regulatory Overview
Our Focus
FDA
Regulations
CRO/ Research
Monitor Sponsor Site
• Investigator(s)
• Research Coordinator(s)
• Other Research Administration
• Institutional Review Board (IRBs)
22. Regulatory Overview
Code of Federal Regulations
• Requirements for conducting clinical studies
• Outlines responsibilities of the
sponsors, investigators, and IRBs for conducting
trials involving human subjects
23. Regulatory Overview
Code of Federal Regulations
Titles
Chapters
Parts
Sections Subparts
Paragraphs
24. Regulatory Overview
Code of Federal Regulations
Title: CRF Title 21
Chapter: Food and Drugs
Part: 50 Protection of Human Subjects
Subpart: B Informed Consent of Human Subjects
Section: (a) – Basic Elements of Informed Consent
Section Paragraph: (1) Statement that the study
involves research…
25. Regulatory Overview
Code of Federal Regulations
Title: CRF Title 21
Chapter: Food and Drugs
Part: 312 Drugs
Part: 812 Devices
Part: 50 Protection of Human Subjects
Part: 56 Institutional Review Boards (IRBs)
Part: 54 Financial Disclosures
Part: 11 Electronic Records/Electronic
Signatures
27. Fill in the blanks….
Regarding record maintenance, an investigator must
maintain accurate, complete and current
records, including:
21 CFR 812.140 (1)
All _____________ with another
____________, an _______, the
sponsor, a monitor, or ______, including
required ________________.
28. Regulatory Overview
Code of Federal Regulations
Title: CRF Title 21
Chapter: Food and Drugs
Part: 312 Drugs
Part: 812 Devices
Part: 50 Protection of Human Subjects
Part: 56 Institutional Review Boards (IRBs)
Part: 54 Financial Disclosures
Part: 11 Electronic Records/Electronic
Signatures
29. Regulatory Overview
Code of Federal Regulations
Title: CRF Title 21
Chapter: Food and Drugs
Part: 312 Drugs
Part: 812 Devices
Part: 50 Protection of Human Subjects
Part: 56 Institutional Review Boards (IRBs)
Part: 54 Financial Disclosures
Part: 11 Electronic Records/Electronic
Signatures
30. Regulatory Overview
Global Perspective
• ISO 14155 has been designed for medical devices
• ICH GCP has origins in the pharmaceutical industry
• ISO 14115 and ICH GCP complement one another
as they are based on the same principles:
– Patient protection
– Documentations
– Risk-benefit assessments
– Ensuring data validity
31. Agenda
An Overview of Drugs and Devices
Determining the Need for a Clinical Trial
Regulatory Overview
Clinical Trial Similarities
Clinical Trial Differences
FAIR Shake™- The Regulations
32. Clinical Trial Similarities
Regulations
• Regulations that drugs and devices have in
common:
– 21 CFR 11 (electronic records)
– 21 CFR 50 (protection of human subjects)
– 21 CFR 54 (financial disclosure)
– 21 CFR 56 (institutional review board)
33. Clinical Trial Similarities
Regulations
• Within 21 CFR 312 and 21 CFR 812 are many
similarities:
– Submit to FDA before beginning an investigation
– Update annually
– Amendments required when changes are made
– Promotion and charging for the product
– Labeling
– Waivers
– Product accountability
34. Clinical Trial Similarities
Sponsor Responsibilities
DRUGS DEVICES
•Select qualified investigators •Selecting qualified investigators
•Provide info to investigators •Provide info to investigators
•Ensure proper monitoring •Ensure proper monitoring
•Ensure trial is conducted in •Ensure trial is conducted in
accordance with the general
investigational plan and protocols accordance with the general
•Maintain an effective IND with investigational plan, protocol,
respect to the investigations agreement, IRB
•Ensure the FDA and investigators are •Ensure IRB review and approval
promptly informed of significant •Ensure IRB and FDA are promptly
new adverse effects or risks with informed of significant new
respect to the drug information
35. Clinical Trial Similarities
Sponsor Responsibilities
DRUGS DEVICES
312.56: ….(paraphrased) Ensuring that 812.46: (paraphrased) Ensuring
the investigation(s) is conducted in compliance with signed agreement,
compliance with the investigational plan, investigational plan, applicable FDA
the signed agreement, and the applicable regulations, and IRB requirements....
regulations….
36. Clinical Trial Similarities
Investigator Responsibilities
DRUGS DEVICES
312.60: ….Ensuring that an investigation 812.110: An investigator shall conduct an
is conducted according to the signed investigation in accordance with the
investigator statement, the signed agreement with the sponsor, the
investigational plan, and applicable investigational plan, this part and other
regulations.... applicable FDA regulations, and any
conditions of approval imposed by an IRB
or FDA.
37. Clinical Trial Similarities
Trials organized
differently
(defined phases
Sponsor v. pilot/pivotal),
responsibiliti but many of the
es similar same
requirements
apply
Investigator
responsibilitie
s similar
Lots of Similarities!
38. Agenda
An Overview of Drugs and Devices
Determining the Need for a Clinical Trial
Regulatory Overview
Clinical Trial Similarities
Clinical Trial Differences
FAIR Shake™- The Regulations
40. Clinical Trial Differences
Agreements
In both drug studies and device studies, the FDA
requires that the investigator comply with the
agreements (21 CFR 312.56 and 21 CFR
812.46), however the agreements are not
identical.
41. Clinical Trial Differences
Agreements - Drugs
• The FDA Form 1572 is the
agreement mandated by the
FDA to be completed by all
investigators involved in a drug
trial.
• The agreement describes an
investigator’s qualifications
and specifies his or her
commitment to adhering to
applicable FDA regulations.
42. Clinical Trial Differences
Agreements - Drugs
Read the SMALL PRINT of the
1572
Supervise
Maintain Records
Adhere to protocol
Learn investigator
brochure
Let FDA inspect
rePort adverse events
Retain records
Inform subjects
Notify IRB
Read the SMALL PRINT of the 1572, The Essential GCP Document;
http://www.wlap.org/filearchive/cacr/CACR_CRE_ 2.ppt#256,1,Read
the SMALL PRINT of the 1572 staff
Train
43. Clinical Trial Differences
Agreements - Drugs
Read the SMALL PRINT of the
1572
Supervise
Maintain Records
Adhere to protocol
Learn investigator
brochure
Let FDA inspect
rePort adverse events
Retain records
Inform subjects
Notify IRB
Read the SMALL PRINT of the 1572, The Essential GCP Document;
Train staff
http://www.wlap.org/filearchive/cacr/CACR_CRE_ 2.ppt#256,1,Read
the SMALL PRINT of the 1572
44. Clinical Trial Differences
Agreements - Devices
• No standard format or specific form required
• Direction provided as to what should be included in
the agreements (21 CFR 812.43)
– Investigator qualifications
– Commitment to conduct the study in accordance with
regulations
– Commitment to supervise device use
– Statement regarding involvement in research that was
terminated (if applicable)
45. Clinical Trial Differences
Training
Training should be approached differently when
beginning a drug study versus beginning a
device study.
46. Clinical Trial Differences
Training
Drugs
• Training on dispensing of product not likely to be needed
• Burden of responsibility to comply with drug regimen lies with
patient/patient’s caregiver
• A sponsor shall select only investigators qualified by training and
experience as appropriate experts to investigate the drug. 21 CFR
312.53
Devices
• Training could be significant and might require the assistance of
engineers, product development, nurses, other physicians, etc.
• Influence of physician technique can be very high depending on
the complexity of device study
• A sponsor shall select investigators qualified by training and
experience to investigate the device. 21 CFR 812.43
48. Clinical Trial Differences
Payments
• Drugs are often provided free of charge to
clinical sites and patients in clinical trials
• Devices expensive to produce
• Having to provide it free could cause a
significant barrier to development
• For some studies, investigator could be
charged for the device (then reimbursed by
Medicare or private insurance)
– “Category B Investigational Devices”
49. Clinical Trial Differences
Adverse Events
Due to the systemic nature of drugs, all adverse
events will need to be captured and analyzed as
potentially related to the drug. Devices have a local
affect, and the likelihood of an adverse event being
related to the device is easier to determine. For this
reason, not all negative occurrences in a device
study are reportable.
50. Clinical Trial Differences
Adverse events
• AE: Adverse Effect
• SAE: Serious Adverse Effect
ADEs
• ADE: Adverse Device Effect
UADEs
AEs • SADE: Serious Adverse
FDA Device Effect
UADEs
SADEs • UADE: Unanticipated
Adverse Device Effect
• FDA UADE: Unanticipated
Adverse Device Effect that is
Source:
also SERIOUS
Michaels, MB, Applied
Clinical Trials, August
2011, pages 36.
51. Clinical Trial Differences
Adverse Events
• UADEs- report to Sponsor and IRB no later
than 10 days after learning of the event
52. Clinical Trial Differences
Adverse Events
• Immediately conduct investigation
• If UADE presents unreasonable risks to
subjects, sponsor shall terminate all
investigations within 5 working days of making
that decision
53. Key Points
• Devices have local affect, drugs
systemic
• Follow different regulatory pathways
• Clinical trials very similar in
requirements
Agreements
• Differences lie in the details:
Training
Payments
Adverse Events
54. Agenda
An Overview of Drugs and Devices
Determining the Need for a Clinical Trial
Regulatory Overview
Clinical Trial Similarities
Clinical Trial Differences
FAIR Shake™- The Regulations
56. “You can fool all of the people some of the time, and
some of the people all of the time, but you cannot
fool all of the people all of the time.”
- Abraham Lincoln
59. Adding To The Mix…
Fixed versus
Variable
A decision about regulatory compliance made at one site for
one study may not be the right decision at another site for the
same study or at the same site for another study….
60.
61. 21 CFR 812 - IDEs
• 812.110: An investigator shall conduct an investigation in
accordance with the signed agreement with the
Investigator sponsor, the investigational plan, this part and other
applicable FDA regulations, and any conditions of
approval imposed by an IRB or FDA.
• 812.46: (paraphrased) Ensuring compliance with
Sponsor signed agreement, investigational plan, applicable
FDA regulations, and IRB requirements....
62. Working through the chaos
Federal Regulations
Agreements
Investigational Plan
Requirements of IRB
63. Federal Regulations
• Requirements for conducting clinical studies
• Outlines responsibilities of the sponsors,
investigators, and IRBs for conducting trials
involving human subjects
64. Federal Regulations
FDA Regulations to Know
812
IDEs (Investigational Device Exemptions)
50
Protection of Human Subjects
56
IRBs (Institutional Review Boards)
54
Financial Disclosures
11
Electronic Records/Signatures
65. Federal Regulations
21 CFR 812 - IDEs
• Describes the procedures for the conduct
of clinical investigations of devices
• Sponsor responsibilities
• Investigator responsibilities
66. Federal Regulations
21 CFR 812 - IDEs
• 812.110: An investigator shall conduct an investigation in
accordance with the signed agreement with the
Investigator sponsor, the investigational plan, this part and other
applicable FDA regulations, and any conditions of
approval imposed by an IRB or FDA.
• 812.46: (paraphrased) Ensuring compliance with
Sponsor signed agreement, investigational plan, applicable
FDA regulations, and IRB requirements....
67. Federal Regulations
21 CFR 812 - IDEs
• Overall conduct of a study:
– Labeling
– Promotion
– Selection of Investigators
– Monitoring (securing compliance)
– Record keeping
– IRB approval…..
DOCUMENT IT!
68. Federal Regulations
21 CFR 50 – Human Subject Protection
• The rights, safety, and well-being of the trial subjects
should prevail over interests of science and society.
• Freely given Informed Consent should be obtained from
every subject prior to clinical trial participation.
• The confidentiality of records that could identify subjects
should be protected, respecting the privacy and
confidentiality
69. Federal Regulations
21 CFR 50 – Human Subject Protection
• Specifies:
– Consenting procedures
– Elements to include in an informed consent
– Documentation of informed consent
– Exceptions of informed consent
– Safeguards for children/wards
70. Federal Regulations
21 CFR 50 – Human Subject Protection
• Sponsor obligations:
– Ensure informed consent process at site level is
compliant with regulatory requirements
DOCUMENT IT!
71. Federal Regulations
21 CFR 56 - IRBs
• IRBs – Institutional Review Boards (Ethics Committees)
Review and approve research studies involving
human subjects
• 21 CFR part 56 contains general standards for the
composition, operation, and responsibility of an IRB
that reviews clinical investigations regulated by the FDA
72. Federal Regulations
21 CFR 56 - IRBs
An IRB has the authority to:
• Approve research
• Require modifications in research
• Disapprove research
• Require additional elements of informed consent
are provided
• Waive the requirement for a signed informed
consent
73. Federal Regulations
21 CFR 56 - IRBs
• Sponsor’s obligations:
– Ensure IRB is operating in compliance with 21 CFR 56
– Ensure site is following IRB procedures
DOCUMENT IT!
74. Federal Regulations
21 CFR 54 – Financial Disclosure
• Protect the integrity and reliability of clinical data
• FDA considers whether adequate steps are taken in the
design, conduct, reporting and analysis of studies to
minimize bias
• The FDA works with the applicant/sponsor to minimize
potential bias
75. Federal Regulations
21 CFR 54 – Financial Disclosure
Investigator to
Sponsor to FDA
Sponsor
If financial interests raise questions about data integrity
the FDA may:
• Initiate audits of the data from that investigator
• Request further analyses of data
• Request applicant to conduct additional studies
• Refuse the data
76. Federal Regulations
21 CFR 54 – Financial Disclosure
• Sponsor’s obligations:
• Collect accurate investigator financial information before study
participation (21 CFR 812.43)
• Report COI to FDA at time of application
• Obtain updates throughout the study and for one year after all
study data is submitted
DOCUMENT IT!
77. Federal Regulations
21 CFR 11 – Electronic Records
• Describes How:
– Electronic records, electronic signatures,
and handwritten signatures executed to
electronic records are considered
trustworthy, reliable, and generally
equivalent to paper records and
handwritten signatures executed on paper.
78. Federal Regulations
21 CFR 11 – Electronic Records
• To ensure the authenticity, integrity and confidentiality of
electronic records, controls include:
– Tracking of data entry with an audit trail (paper or electronic)
– Documented verification of data entry accuracy
– Unique electronic signatures
79. Federal Regulations
21 CFR 11 – Electronic Records
• Sponsor’s obligation:
– Know the requirements of 21 CFR 11
– Ensure site and internal (sponsor) compliance
DOCUMENT IT!
80. Working through the chaos
Federal Regulations
Agreements
Investigational Plan
Requirements of IRB
81. Agreements
• Statement of investigator’s commitment to:
– Conduct the investigation in compliance with FAIR
– Supervise device use
– Obtain informed consent
– Other items as agreed upon with sponsor…
DOCUMENT IT!
82. Working through the chaos
Federal Regulations
Agreements
Investigational Plan
Requirements of IRB
84. Working through the chaos
Federal Regulations
Agreements
Investigational Plan
Requirements of IRB
85. Requirements of IRB
• Informed consent procedures
• Adverse event reporting requirements
• Renewal timelines
• Etc.
86. Case Study #1
You are monitoring a site when you
notice that an investigator routinely
signs the consent forms days after the
patients sign them. You’re not sure
what to do. The manager of the brand
new research coordinator tells you that
this is no big deal and there is nothing
to address.
She said “It’s not in the regs…..” Is she
right?
88. Case Study #2
A monitor notes that all of the IRB approvals
were on file at a site, but some of the
correspondence back and forth regarding the
approvals was missing. The RC refused to
locate the missing documentation.
The monitor insists “It’s in the Regs….” Is the
monitor correct?
89. Federal Regulations
FDA requires that all correspondence with an IRB be maintained (21 CFR 812.140)
Agreements
Investigational Plan
Requirements of IRB
90. Case Study #3
You have a site that routinely takes case report
forms (CRFs) into the exam room while seeing
patients. While much of the information you
need for the study is included in the patient’s
regular assessment, they write the other data
directly onto the CRF. You think they need a
separate source, but you’re not sure.
You dig into the regulations and find what???
91. Federal Regulations
Agreements Could be in an agreement
Could be in an
Investigational Plan investigational plan
Requirements of IRB
92. Sandra Maddock Brandy Smith
CEO and President Director of Clinical Monitoring Services
Meet Our Team
John Lehman Mary Lewis
Director of Business Development Clinical Auditor
95. References
• FDA’s official website:
• www.fda.gov
• GCP Guidances and Information Sheets
• http://www.fda.gov/oc/gcp/guidance.html
• Informed Consent
• A Guide To Informed Consent:
• http://www.fda.gov/oc/ohrt/irbs/informedconsent.html
• Protection of Subjects:
• http://www.fda.gov/cdrh/devadvice/ide/informed_consent.shtml
• Running clinical trials
• http://1.usa.gov/ILt1tc
Editor's Notes
According to the Federal Food, Drug, and Cosmetics Act, The term "drug" means (A) articles recognized in the official United States Pharmacopeia, official Homeopathic Pharmacopeia of the United States, or official National Formulary, or any supplement to any of them; and (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (D) articles intended for use as a component of any articles specified specific clauses of the Act.
Consider situations where devices may have patient burden- If a device requires a drug component
Drugs too
Look up roles for drugs
21 CFR 54 became final rule in 1999. Guidance for financial disclosure in 2000.