Reporting to the IRB can mean navigating a maze of regulatory requirements. Staying current on what’s required – and what isn’t – is challenging. In this webinar, Quorum Review’s regulatory expert, Mitchell Parrish, JD, RAC, CIP, helps you concretely understand IRB reporting obligations.
This presentation describes the procedures and criteria for the assessment of research by the Human Research Ethics Committee (HREC) of the TU Delft (see: http://hrec.tudelft.nl/)
This presentation describes the procedures and criteria for the assessment of research by the Human Research Ethics Committee (HREC) of the TU Delft (see: http://hrec.tudelft.nl/)
A presentation by Niklas Nielsen at the 2017 meeting of the Scandinavian Society of Anaestesiology and Intensive Care Medicine.
All available content from SSAI2017: https://scanfoam.org/ssai2017/
Delivered in collaboration between scanFOAM, SSAI & SFAI.
Institutional ethics committee(IEC): A brief insight, by Rxvichu!!RxVichuZ
This is my 26th powerpoint.....its on INSTITUTIONAL ETHICS COMMITTEE(IEC) ...also known as RESEARCH and ETHICAL COMMITTEE(REC). It focusses on the general principles, that ought to be made, while selecting subjects for study.
Brief points, under specific headings, have been included.
Do go through this, and let me know your feedbacks.
Thank you!
Vishnu.
The physician shall comply with observing the implementation of all moral criteria and guidelines as well as the social and religious values laid down by the competent authority for conducting medical research on human beings
ETHICS COMMITTEE
MEMBERS OF ETHICS COMMITTEE
SOME ETHICS COMMITTEE AROUND THE WORLD
What authority does EC/IRB have?
.
.
.
FOR ENROLLMENT CALL US ON - 9028839789
https://pristynresearch.com/
MAIL ID - pristynresearch@gmail.com
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Quorum Review IRB presented a live webinar in September 2014 covering the details of IRB review for medical device studies and their special considerations.
A presentation by Niklas Nielsen at the 2017 meeting of the Scandinavian Society of Anaestesiology and Intensive Care Medicine.
All available content from SSAI2017: https://scanfoam.org/ssai2017/
Delivered in collaboration between scanFOAM, SSAI & SFAI.
Institutional ethics committee(IEC): A brief insight, by Rxvichu!!RxVichuZ
This is my 26th powerpoint.....its on INSTITUTIONAL ETHICS COMMITTEE(IEC) ...also known as RESEARCH and ETHICAL COMMITTEE(REC). It focusses on the general principles, that ought to be made, while selecting subjects for study.
Brief points, under specific headings, have been included.
Do go through this, and let me know your feedbacks.
Thank you!
Vishnu.
The physician shall comply with observing the implementation of all moral criteria and guidelines as well as the social and religious values laid down by the competent authority for conducting medical research on human beings
ETHICS COMMITTEE
MEMBERS OF ETHICS COMMITTEE
SOME ETHICS COMMITTEE AROUND THE WORLD
What authority does EC/IRB have?
.
.
.
FOR ENROLLMENT CALL US ON - 9028839789
https://pristynresearch.com/
MAIL ID - pristynresearch@gmail.com
FACEBOOK- https://www.facebook.com/pristynsolutions
INSTAGRAM- https://www.instagram.com/pristyn_res...
TWITTER- https://twitter.com/Pristynresearch
SLIDESHARE- https://www.slideshare.net/azherkhan5916
LINKEDIN- https://www.linkedin.com/in/pristyn-research-191072119/
ADDRESS-
1) Parmar Trade Centre, A-wing,105/106, Sadhu Vaswani Chowk, Pune, 411001. Email: info@pristynresearch.com Phone: 09028839789
2)T-21/4 ,Opposite To Expert Global, Garware Stadium Road , Software Technology Park of India(STPI), MIDC, Aurangabad-431001. Email: info@pristynresearch.com Call us: 09607709586
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
A regulatory strategy is critical to the commercialization of biomedical technologies. In particular, technologies such as new drugs and medical devices have more regulatory needs, and the strategy should be considered simultaneous to a commercialization pathway.
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.
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
Social media is a powerful and widespread source of information and connectivity. Many in research are wondering whether and how to use social media to improve awareness and retention for their clinical trials. Quorum Review's Regulatory Attorney, Dominic Chiarelli, presents about the power of social media and practical tips for how to best harness social media in research.
Quorum Review's April 2014 Institution Bulletin includes a letter from CEO, Cami Gearhart, JD, discussing the need to reform the regulations around biobanking and repositories, HIPAA templates and procedures, and the lessons IRBs can learn from 2013 FDA Warning Letters.
Quorum Review presents a special webinar with J. Claire Carbary, JD, CIP to discuss IRB expectations surrounding Biobanking and Future Research. This presentation covers U.S. and Canadian regulatory/legal requirements regarding collection and use of samples and data. We also discuss how to address these issues in a study protocol and consent, as well as implications of returning results to study participants.
Quorum Review's February 2014 Institution Bulletin includes a letter from CEO, Cami Gearhart, JD, discussing factors to consider when assessing the strength of your IRB, SACHRP guidelines on internet research, international ethics review, and how the 2014 Congressional Appropriations Bill impacts clinical research.
Quorum Review's October 2013 Institution Bulletin includes Letter from CEO, Cami Gearhart, JD, addressing the delicate balance of protecting privacy and future research, as well as Quorum's insights on recent FDA guidance regarding how IRB's evaluate clinical trials as well as determining whether or not an IND is needed for a particular drug study.
Quorum Review presents a special webinar with J. Claire Carbary, JD, CIP to discuss IRB expectations when research involves minors or adults with limited capacity to consent. The presenter will outline guidance in recruiting these populations and clarify who might serve as the appropriate legal representatives based on federal regulations and state law.
Quorum Review's July 2013 Institution Bulletin includes Letter from CEO, Cami Gearhart, JD, addressing support for effective human research protection programs, as well as Quorum's insights on two important topics: The first addresses exculpatory language in consent forms; the second provides insight on considerations when planning eConsent implementation and questions to ask the IRB.
Presented by Quorum Review Regulatory Attorney J. Claire Carbary, JD, CIP, and Consent Solutions President and CEO Susan G. Brink, DrPH, this presentation discusses considerations in the review and approval of eConsent processes, meeting the requirements related to documentation of IRB review and approval, the decision to use an eConsent, how an eConsent system may impact IRB process, and questions regarding what the IRB should consider
when evaluating the use of eConsent for a given study.
With the adoption of EHRs and electronic data collection, researchers, trial sponsors and IRBs are looking toward possible adoption of electronic consent processes and systems. The use of an eConsent process has many advantages. However, early consideration, planning and close coordination at the IRB review stage is important before implementation.
Quorum Review's Institution Bulletin includes Letter from CEO, Cami Gearhart, JD, addressing OHRP's determination letter referring to consent forms and the SUPPORT trail, as well as Quorum's insights on two important topics: The first addresses consent for legally incapacitated adults and subjects physically unable to sign; the second reviews the recent FDA Subpart D changes on implications for placebo-controlled pediatric trials.
Presented by J. Claire Carbary, JD, CIP, this webinar addresses some of the common issues confronted during ethics review of advertisements, consent forms and study tools from the perspective of the IRB.
Development of effective recruitment tools and consent documents is essential to meeting enrollment goals and keeping a clinical trial moving forward.
Advertising is the beginning of the informed consent and subject selection process and sets the stage for the consent process. Understanding the regulatory and ethical obligations that form IRB evaluation of advertisements and consent forms is critical during the development of the recruitment and consent plans and tools.
Quorum Review's Institution Bulletin includes Letter from CEO, Cami Gearhart, JD, on Tuskegee Syphilis Experiment as a leading key component of today's subject protection requirements, as well as Quorum's insights on two recent FDA draft guidances: The first addresses specific IRB responsibilities and explains how an IRB may efficiently fulfill them and the second explains that researchers must obtain informed consent before initiating clinical screening for eligibility.
When designing pediatric research, one size does not fit all. Simply adapting the adult clinical study protocol into its child-sized version will not be enough to gain IRB approval.
Research involving minors must prioritize the rights, safety, and welfare of its young participants, and the FDA has issued substantial regulations to ensure pediatric research is conducted safely and ethically.
Recomendações da OMS sobre cuidados maternos e neonatais para uma experiência pós-natal positiva.
Em consonância com os ODS – Objetivos do Desenvolvimento Sustentável e a Estratégia Global para a Saúde das Mulheres, Crianças e Adolescentes, e aplicando uma abordagem baseada nos direitos humanos, os esforços de cuidados pós-natais devem expandir-se para além da cobertura e da simples sobrevivência, de modo a incluir cuidados de qualidade.
Estas diretrizes visam melhorar a qualidade dos cuidados pós-natais essenciais e de rotina prestados às mulheres e aos recém-nascidos, com o objetivo final de melhorar a saúde e o bem-estar materno e neonatal.
Uma “experiência pós-natal positiva” é um resultado importante para todas as mulheres que dão à luz e para os seus recém-nascidos, estabelecendo as bases para a melhoria da saúde e do bem-estar a curto e longo prazo. Uma experiência pós-natal positiva é definida como aquela em que as mulheres, pessoas que gestam, os recém-nascidos, os casais, os pais, os cuidadores e as famílias recebem informação consistente, garantia e apoio de profissionais de saúde motivados; e onde um sistema de saúde flexível e com recursos reconheça as necessidades das mulheres e dos bebês e respeite o seu contexto cultural.
Estas diretrizes consolidadas apresentam algumas recomendações novas e já bem fundamentadas sobre cuidados pós-natais de rotina para mulheres e neonatos que recebem cuidados no pós-parto em unidades de saúde ou na comunidade, independentemente dos recursos disponíveis.
É fornecido um conjunto abrangente de recomendações para cuidados durante o período puerperal, com ênfase nos cuidados essenciais que todas as mulheres e recém-nascidos devem receber, e com a devida atenção à qualidade dos cuidados; isto é, a entrega e a experiência do cuidado recebido. Estas diretrizes atualizam e ampliam as recomendações da OMS de 2014 sobre cuidados pós-natais da mãe e do recém-nascido e complementam as atuais diretrizes da OMS sobre a gestão de complicações pós-natais.
O estabelecimento da amamentação e o manejo das principais intercorrências é contemplada.
Recomendamos muito.
Vamos discutir essas recomendações no nosso curso de pós-graduação em Aleitamento no Instituto Ciclos.
Esta publicação só está disponível em inglês até o momento.
Prof. Marcus Renato de Carvalho
www.agostodourado.com
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
Couples presenting to the infertility clinic- Do they really have infertility...Sujoy Dasgupta
Dr Sujoy Dasgupta presented the study on "Couples presenting to the infertility clinic- Do they really have infertility? – The unexplored stories of non-consummation" in the 13th Congress of the Asia Pacific Initiative on Reproduction (ASPIRE 2024) at Manila on 24 May, 2024.
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.
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TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
Acute scrotum is a general term referring to an emergency condition affecting the contents or the wall of the scrotum.
There are a number of conditions that present acutely, predominantly with pain and/or swelling
A careful and detailed history and examination, and in some cases, investigations allow differentiation between these diagnoses. A prompt diagnosis is essential as the patient may require urgent surgical intervention
Testicular torsion refers to twisting of the spermatic cord, causing ischaemia of the testicle.
Testicular torsion results from inadequate fixation of the testis to the tunica vaginalis producing ischemia from reduced arterial inflow and venous outflow obstruction.
The prevalence of testicular torsion in adult patients hospitalized with acute scrotal pain is approximately 25 to 50 percent
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 Smell
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 primary categories of smells and the concept of odor blindness.
Explain the structure and location of the olfactory membrane and mucosa, including the types and roles of cells involved in olfaction.
Describe the pathway and mechanisms of olfactory signal transmission from the olfactory receptors to the brain.
Illustrate the biochemical cascade triggered by odorant binding to olfactory receptors, including the role of G-proteins and second messengers in generating an action potential.
Identify different types of olfactory disorders such as anosmia, hyposmia, hyperosmia, and dysosmia, including their potential causes.
Key Topics:
Olfactory Genes:
3% of the human genome accounts for olfactory genes.
400 genes for odorant receptors.
Olfactory Membrane:
Located in the superior part of the nasal cavity.
Medially: Folds downward along the superior septum.
Laterally: Folds over the superior turbinate and upper surface of the middle turbinate.
Total surface area: 5-10 square centimeters.
Olfactory Mucosa:
Olfactory Cells: Bipolar nerve cells derived from the CNS (100 million), with 4-25 olfactory cilia per cell.
Sustentacular Cells: Produce mucus and maintain ionic and molecular environment.
Basal Cells: Replace worn-out olfactory cells with an average lifespan of 1-2 months.
Bowman’s Gland: Secretes mucus.
Stimulation of Olfactory Cells:
Odorant dissolves in mucus and attaches to receptors on olfactory cilia.
Involves a cascade effect through G-proteins and second messengers, leading to depolarization and action potential generation in the olfactory nerve.
Quality of a Good Odorant:
Small (3-20 Carbon atoms), volatile, water-soluble, and lipid-soluble.
Facilitated by odorant-binding proteins in mucus.
Membrane Potential and Action Potential:
Resting membrane potential: -55mV.
Action potential frequency in the olfactory nerve increases with odorant strength.
Adaptation Towards the Sense of Smell:
Rapid adaptation within the first second, with further slow adaptation.
Psychological adaptation greater than receptor adaptation, involving feedback inhibition from the central nervous system.
Primary Sensations of Smell:
Camphoraceous, Musky, Floral, Pepperminty, Ethereal, Pungent, Putrid.
Odor Detection Threshold:
Examples: Hydrogen sulfide (0.0005 ppm), Methyl-mercaptan (0.002 ppm).
Some toxic substances are odorless at lethal concentrations.
Characteristics of Smell:
Odor blindness for single substances due to lack of appropriate receptor protein.
Behavioral and emotional influences of smell.
Transmission of Olfactory Signals:
From olfactory cells to glomeruli in the olfactory bulb, involving lateral inhibition.
Primitive, less old, and new olfactory systems with different path
NVBDCP.pptx Nation vector borne disease control programSapna Thakur
NVBDCP was launched in 2003-2004 . Vector-Borne Disease: Disease that results from an infection transmitted to humans and other animals by blood-feeding arthropods, such as mosquitoes, ticks, and fleas. Examples of vector-borne diseases include Dengue fever, West Nile Virus, Lyme disease, and malaria.
micro teaching on communication m.sc nursing.pdfAnurag Sharma
Microteaching is a unique model of practice teaching. It is a viable instrument for the. desired change in the teaching behavior or the behavior potential which, in specified types of real. classroom situations, tends to facilitate the achievement of specified types of objectives.
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4. • Questions & Answers
• Feel free to submit questions at any point
during the webinar using the chat box on your
webinar dashboard
• Responses will be sent by the presenters
following the presentation
4
WEBINAR HOUSEKEEPING
5. • Recording & Slide Deck
• The webinar recording and slide deck will be
posted on our website within 5 business days
• We will email you a link to view the recording
as soon as it is available
• Feel free to share the link with your staff
and/or colleagues
5
WEBINAR HOUSEKEEPING
6. • ABOUT QUORUM REVIEW IRB
6
ABOUT QUORUM REVIEW IRB
Accredited
Fully accredited by AAHRPP through 2014
Fully compliant with FDA and OHRP requirements
Regulatory
Leadership
6 in-house licensed attorneys providing guidance and
thought-leadership
International
Boards available for the review of U.S. and Canadian
studies– can review for GCP and IHC internationally
Strong
Framework
One of the largest IRBs in the U.S. with ~180 employees
Quorum Review is the ONLY equivalently sized IRB not
owned by Venture Capital
Certified IRB
Professionals
(CIP)
60% of Affiliated IRB members, 40% of Regulatory staff
and 20% of study management & study support positions
7. • 15 Board meetings each week
• 24-hour site turnaround, 36-hour amendment review,
and same day site changes
• One time CV and audit documentation submission
• Support available 8am-8pm ET
• Dedicated Study Manager
• Industry leading legal team
7
THE QUORUM ADVANTAGE
8. • Secure portal with SmartForms, status
reports, and approval documents
• Customized Phase I and Expeditable
Research processes
• Flexible, customized process for AMCs
– Over 850 Institutions work with Quorum
• 100% Quality Control on all documents
• Commitment to 6 Sigma Process Analysis
8
THE QUORUM ADVANTAGE
9. Quorum Review Regulatory Attorney
Mitchell E. Parrish, JD, RAC,CIP
9
ABOUT THE PRESENTER
IRB Experience
Joined Quorum Review, Inc. in January 2010
CIP certification
Regulatory Affairs Certification
Member of Public Responsibility in
Medicine & Research (PRIM&R)
Legal Background
Juris Doctor from University of Oregon
Member of the Washington State Bar
Association (WSBA)
Member of the Association of Corporate
Counsel (ACC) and Regulatory Affairs
Professionals Society (RAPS)
11. Role of the IRB 11
Problems with Reporting 15
Regulatory Landscape 18
Obligations for Reporting Safety Information 26
Unanticipated problems that are Adverse Events
SUSAR
UADE
Recommended practices for reporting Safety Information
Obligations for Reporting Non-Safety Information 48
Unanticipated Problems that are not Adverse Events
Recommended practices for reporting Non-Safety Information
Key Take Aways 62
11
Topic Page
Webinar Overview
13. Role of the IRB
The primary purpose of both initial and
continuing review of [a] study is ‘to assure the
protection of the rights and welfare of the human
subjects’ (§ 56.109(f). To fulfill its obligations… an
IRB must have, among other things, information
concerning unanticipated problems involving
risk to human subjects in the study, including
adverse events that are considered unanticipated
problems.”
FDA Guidance for Clinical Investigators, Sponsors, and IRBs, Adverse
Event Reporting to IRBs—Improving Human Subject Protection
(January 2009)
“
13
17. Problems with Reporting – Unnecessary Reporting
Much of the information that is being reported does not
meet reporting requirements and therefore results in the
unnecessary expenditure of resources by all stakeholders.
Specifically, “the way that ‘unanticipated problem’ is interpreted
does not yield information about adverse events that is useful
to IRBs and thus hinders their ability to ensure protection of
human subjects.”
17
“
FDA Guidance for Clinical Investigators, Sponsors, and IRBs,
Adverse Event Reporting to IRBs—Improving Human Subject Protection
(January 2009)
18. Problems with Reporting – No Explanation Provided
18
Not only is unnecessary information reported, but also reported information
is not explained:
FDA Guidance for Clinical Investigators, Sponsors, and IRBs,
Adverse Event Reporting to IRBs—Improving Human Subject Protection
(January 2009)
“In the years since the IRB and IND regulations issued,
changes in the conduct of clinical trials (e.g., increased use of
multi-center studies, international trials) have complicated the
reporting pathways for adverse event information described in
the regulations. IN particular the practice of local investigators
reporting individual, unanalyzed events to IRBs, including
reports of events from other study sites that the
investigator receives from the sponsor of a multi-center
study—often with limited information no explanation of
how the event represents an unanticipated problem—has
led to the submission of large numbers of reports to IRBs
that are uninformative.”
20. Regulations (HHS/FDA)
• 45 CFR 46 (Protection of Human Subjects)
• 21 CFR 56 (Institutional Review Boards)
• 21 CFR 312 (Investigational New Drug Application)
• 21 CFR 320 (Bioavailability and Bioequivalence Requirements)
• 21 CFR 812 (Investigational Device Exemptions)
Guidance (HHS/FDA)
• HHS, Guidance on Reviewing and Reporting Unanticipated Problems Involving Risks to Subjects or
Others and Adverse Events, January 15, 2007
• FDA, Guidance for Clinical Investigators, Sponsors, and IRBs, Adverse Event Reporting to IRBs—
Improving Human Subject Protection, January, 2009
• FDA, Guidance for Industry and Investigators, Safety Reporting Requirements for INDs and BA/BE
Studies, December, 2012
20
Regulatory Landscape
21. Regulatory Landscape
FDA and HHS regulations require the IRB to receive safety and other
information throughout study and during continuing review to ensure the
criteria for approval is still met and to ensure the safety, rights, and welfare
of subjects are protected
21
45 CFR 46.109 and 46.111; 21 CFR 56.109 and 56.111
From Where is the Obligation to Report Safety Information
to the IRB derived?
22. Regulatory Landscape
There is a lot of safety data and other information in clinical trials, so where
in the regulations does it say exactly what to report to the IRB?
While the regulations do not contain specifics, they do provide the term
“Unanticipated Problem” (UP)
22
From Where is the Obligation to Report Safety Information
to the IRB derived? (continued)
23. Regulatory Landscape
Unanticipated Problem
21 CFR 312.66 – “The investigator shall . . .
Promptly report to the IRB . . . All unanticipated
problems involving risk to human subjects or
others.”
21 CFR 56.108(b)(1) – “[E]ach IRB shall: …Follow
written procedures for ensuring prompt reporting to
the IRB, appropriate institutional officials, and the
Food and Drug Administration of: (1) Any
unanticipated problem . . . .”
45 CFR 46.103(b) (4) – An IRB must have “[W]ritten
procedures for ensuring prompt reporting to the
IRB , appropriate institutional officials, and the
department or agency head of (i) any unanticipated
problems involving risks to subjects or others. . . .
23
24. Regulatory Landscape
Unanticipated Problem
Unanticipated Problem = Any incident, experience,
or outcome that meets all of the following criteria:
Unexpected (in terms of nature severity or frequency)
given(a) the research procedures that are described
in the protocol-related documents, and (b) the
characteristics of the subject population being studied
Related or possibly related to participation in the
research
Suggests that the research places subjects or others
at a greater risk of harm (including physical,
psychological, economic, or social harm) than was
previously known or recognized
HHS Guidance, Guidance on Reviewing and Reporting Unanticipated
Problems Involving Risks to Subjects or Others and Adverse Events
(January 15, 2007)
24
*Note: This general criteria is essentially
the same for unanticipated problems
under FDA regulations as well.
1
2
3
25. Regulatory Landscape
Unanticipated Problems & Adverse Events
In addition to defining “Unanticipated Problem,” the
HHS Guidance also explains that there are UPs that
stem from adverse events, essentially safety related
UPs, and those that do not stem from adverse
events, essentially non-safety related UPs.
Adverse Event: Any untoward or unfavorable
medical occurrence in a human subject, including
any abnormal sign (for example abnormal physical
exam or laboratory finding), symptom, or disease,
temporally associated with the subject's participation
in the research, whether or not considered related to
the subject’s participation in the research. This
encompasses both physical and psychological
harms and can be categorized as “internal”
(happening at the site) or “external” (happening at
other locations).
FDA Guidance, Adverse Event Reporting to IRBs –
Improving Human Subject Protection
(January 2009)
25
Note: The terms “adverse effect”
and “adverse experience” are
interchangeable with “adverse
event.”
26. Regulatory Landscape
Unanticipated Problems and Adverse Events
26
Adapted from HHS Guidance, Guidance on Reviewing and Reporting Unanticipated Problems Involving Risks to Subjects or Others and
Adverse Events (January 15, 2007); See also FDA Guidance, Adverse Event Reporting to IRBs – Improving Human Subject Protection
(January 2009)
• Safety Related:
Do not report
adverse events that
are not UPs
• Non-Safety Related:
Must report UPs that
are not adverse
events
• Safety Related:
Must report adverse
events that are UPs
Under 45 CFR 46
do not report A, do report B + C.
28. Regulatory Landscape
Unanticipated Problems and Adverse Events
28
Adapted from HHS Guidance, Guidance on Reviewing and Reporting Unanticipated Problems Involving Risks to Subjects or Others and
Adverse Events (January 15, 2007); See also FDA Guidance, Adverse Event Reporting to IRBs – Improving Human Subject Protection
(January 2009)
• Safety Related:
Do not report
adverse events that
are not UPs
• Non-Safety Related:
Must report UPs that
are not adverse
events
• Safety Related:
Must report adverse
events that are UPs
Under 45 CFR 46
do not report A, do report B + C.
29. Reporting Safety Information to the IRB
29
SUSAR:
SERIOUS & UNEXPECTED SUSPECTED
ADVERSE REACTIONS
UP:
UNANTICIPATED PROBLEM
UADE:
UNANTICIPATED ADVERSE
DEVICE EFFECT By its very nature, if an event is
an SUSAR or a UADE then it is a UP
and must be reported to the IRB
30. Reporting Safety Information - SUSAR
Serious and unexpected suspected adverse reaction (SUSAR) originates from 21 CFR 312
and is designed to guide sponsors on when to submit IND safety reports to the FDA and
investigators
30
1. Serious (Death, life-threatening, inpatient
hospitalization or prolongation of existing hospitalization,
persistent or significant incapacity, substantial disruption
of the ability to conduct normal life functions, and
congenital anomaly/birth defect)
2. Unexpected (an event not listed in the investigator
brochure or not listed at the specificity or severity
observed; or an event not consistent with the risk
information described in the investigational plan)
3. Suspected Adverse Reaction (“a reasonable
possibility that the drug caused the adverse event”)
Evidence to suggest a causal relationship between the
drug and event
Must report to the IRB all SUSARs that satisfy these three criteria:
31. Reporting Safety Information - SUSAR
Individual Occurrences
A single occurrence of an event that is
uncommon and known to be strongly
associated with drug exposure
(e.g., angioedema, hepatic injury,
Stevens-Johnson Syndrome)
31
32. Reporting Safety Information - SUSAR
32
In a phase II study testing an
investigational drug for Hepatitis C, a
subject experiences hepatic injury. In
addition to the investigational drug, the
subject was continuing her standard
Hepatitis C therapy at the time of
hepatic injury.
Is this individual occurrence a suspected adverse reaction?
Example:
33. Reporting Safety Information - SUSAR
In a phase II study testing an
investigational drug for Hepatitis C, a
subject experiences hepatic injury. In
addition to the investigational drug, the
subject was continuing her standard
Hepatitis C therapy at the time of
hepatic injury.
33
Is this individual occurrence a suspected adverse reaction?
Example:
YES
34. Reporting Safety Information - SUSAR
34
One or more Occurrences
One or more occurrences of an event that is
not commonly associated with drug exposure,
but is otherwise uncommon in the population
exposed to the drug (e.g., tendon rupture,
progressive multifocal leukoencephalopathy)
35. Reporting Safety Information - SUSAR
35
Is this one occurrence a suspected adverse reaction?
Example:
A subject with extrapulmonary small-cell
carcinoma receiving an investigational
chemotherapy agent experiences a
bowel perforation during his second
cycle of chemotherapy.
36. Reporting Safety Information - SUSAR
36
Is this one occurrence a suspected adverse reaction?
Example:
A subject with extrapulmonary small-cell
carcinoma receiving an investigational
chemotherapy agent experiences a
bowel perforation during his second
cycle of chemotherapy.
NO
37. Reporting Safety Information - SUSAR
37
Aggregate Analysis of Specific Events
An aggregate analysis of specific events observed
in a clinical trial (such as known consequences of
the underlying disease or condition under
investigation or other events that commonly occur in
the study population independent of drug therapy)
that indicates those events occur more frequently in
the drug treatment group than in a concurrent or
historical control group.
38. Reporting Safety Information - SUSAR
17 oncology sites are participating in a
research study comparing an investigational
chemotherapy agent to standard therapy in
subjects ages 60-85. Of those subjects
receiving the investigational drug, an
average of 35% of subjects across the 17
sites experience deep vein thrombosis.
38
Example:
Does this aggregate analysis indicate a suspected adverse reaction?
39. Reporting Safety Information - SUSAR
17 oncology sites are participating in a
research study comparing an investigational
chemotherapy agent to standard therapy in
subjects ages 60-85. Of those subjects
receiving the investigational drug, an
average of 35% of subjects across the 17
sites experience deep vein thrombosis.
39
Example:
Does this aggregate analysis indicate a suspected adverse reaction?
YES
40. Reporting Safety Information - SUSAR
Critical to understand the
definition of “Suspected
Adverse Reaction” coupled
with the examples the FDA
provides:
40
Individual occurrence
One or more occurrences
Aggregate analysis
41. Reporting Safety Information - SUSAR
Without this understanding, the FDA
explains that the following problem occurs:
Reporting of individual events even though unlikely that
the event was caused by the drug. Examples:
41
Serious adverse experiences (e.g. mortality or major
morbidity) that are unlikely to have been
manifestations of the underlying disease
Serious adverse experiences that commonly
occurred in the study population independent of
drug exposure (e.g. strokes or acute myocardial
infarction in an elderly population)
Serious adverse experiences that were study
endpoints (i.e. the study was evaluating whether the
drug reduced the rate of these events)
Such reporting causes a “drain on
resources” when the FDA, and
IRBs are inundated with “generally
uninformative” Safety Information
especially when reported as single
events without any context
42. Reporting Safety Information - UADE
42
Unanticipated Adverse Device Effect
(UADE) originates from 21 CFR 812 and is
designed to guide sponsors on when to
submit reports to the FDA and investigators
Must report to the IRB all UADEs that satisfy the
following criteria:
Serious (death, life-threatening, serious
problem)
Not previously identified (an effect not
previously identified in nature, severity, or
degree of incidence in the investigational plan
or application)
Caused by, or associated with, a device
43. Reporting Safety Information - UADE
FDA Guidance for Clinical Investigators, Sponsors, and IRBs,
Adverse Event Reporting to IRBs—Improving Human Subject
Protection (January 2009)
43
Individual occurrence
One or more occurrences
Multiple occurrences determined
through an aggregate analysis
Essentially states that reporting UADEs to the IRB should be
treated the same as reporting SUSARs to the IRB
While not in the device regulations and while there are different
considerations between safety information for drugs and devices,
take into account whether the effect is a:
44. Recommended Practices for Reporting Safety Information
For Multi-center studies:
44
FDA Guidance for Clinical Investigators, Sponsors, and IRBs, Adverse Event Reporting to IRBs—Improving Human Subject Protection
(January 2009); FDA Guidance for Industry and Investigators, Safety Reporting Requirements for INDs and BA/BE Studies (December 2012)
Even though the FDA regulations indicate it is the investigator’s responsibility to notify the IRB
of unanticipated problems (21 CFR 312.66)—FDA guidance states: “Investigators must rely
on the sponsor to provide them information about AEs occurring at other study sites”
“Although the investigator’s view of the causal relationship between an adverse event and the
investigational drug is important, FDA believes that the sponsor is better positioned than the
individual investigator to assess the overall safety of the investigational drug because the
sponsor has access to serious adverse event reports from multiple study sites and is able to
aggregate and analyze these reports.”
“The sponsor is in a better position to process and analyze the significance of AE
information from multiple sites…and to make a determination about whether an AE is an
unanticipated problem”
FDA supports an arrangement in which the sponsor prepares UP reports and submits to the
IRB “when the sponsor, investigator, and IRB have made an explicit agreement for the
sponsor to report directly to the IRB”
45. Recommended Practices for Reporting Safety Information
While Investigators may report SUSARs and UADEs to the IRB,
Quorum recommends that Sponsors/CROs submit SUSAR and
UADE information to the IRB on behalf of investigators. This
means . . .
45
(continued)
• The Sponsor/CRO should inform investigators and arrange with the IRB
that it will report on behalf of investigators (arrangement with IRB should
include in what format to report)
• The protocol should not state generally that “all adverse events require
reporting the IRB” or include similar language because then if “all adverse
events” are subsequently not reported, investigators run the risk of being
out of compliance with the protocol
Also it is not appropriate to submit all AEs to the IRB, just AEs that
are SUSARs or UADEs!
46. Recommended Practices for Reporting Safety Information
For single-center or
investigator initiated studies:
46
The investigator is likely the one
reporting to the IRB
Also it is not appropriate to submit
all AEs to the IRB, just AEs that
are SUSARs or UADEs!
This still means:
The investigator can arrange with
IRB in what format to report
The protocol should still not state
generally that “all adverse events
require reporting the IRB” or include
similar language because then if “all
adverse events” are subsequently
not reported, investigators run the
risk of being out of compliance with
the protocol
47. Recommended Practices for Reporting Safety Information
47
(continued)
Report SUSARs and
UADEs “promptly” to
the IRB “Promptly” is generally
considered 10 business days,
which is supported in the FDA’s
guidance on reporting AEs
to the IRB
This 10-day timeframe exists whether there is an
arrangement for the sponsor to submit on behalf of the
IRB or whether the investigator is responsible for
submitting to the IRB
TIMING of Reporting to the IRB
48. Recommended Practices for Reporting Safety Information
48
(continued)
• What to report
• Whether to report
• How to report
• When to report
QUESTIONS ABOUT:
CONTACT the
50. Unanticipated Problems and Adverse Events
50
Adapted from HHS Guidance, Guidance on Reviewing and Reporting Unanticipated Problems Involving Risks to Subjects or Others and
Adverse Events (January 15, 2007); See also FDA Guidance, Adverse Event Reporting to IRBs – Improving Human Subject Protection
(January 2009)
• Safety Related:
Do not report
adverse events that
are not UPs
• Non-Safety Related:
Must report UPs that
are not adverse
events
• Safety Related:
Must report adverse
events that are UPs
Reporting Non-Safety Information to the IRB
51. 51
Reporting Non-Safety Information to the IRB
UNEXPECTED
UP:
UNANTICIPATED
PROBLEM
You MUST report ALL
UP’s to the IRB
GREATER RISK OF
HARM
RELATED OR POSSIBLY
RELATED
52. 52
Reporting Non-Safety Information to the IRB
• Failure to obtain informed consent
• Major protocol deviations (e.g.
inclusion/exclusion violation; omitting a
study procedure)
• Study personnel misconduct that
adversely impacts the study
• Adverse findings by a regulatory
agency, medical board, or other
relevant body
Unanticipated Problems - Examples:
Are these UPs?
* Whether these are UPs depends on the type of study and the specific factors
surrounding each event or incident
53. 53
Reporting Non-Safety Information to the IRB
An investigator is conducting behavioral research and collects
individually identifiable sensitive information about illicit drug
use by surveying college students. The data is stored on a
laptop computer that is password protected. The laptop is
stolen from the investigator’s car.
Is this reportable to the IRB as a UP?
Unanticipated Problems - Examples:
54. 54
Reporting Non-Safety Information to the IRB
YES
An investigator is conducting behavioral research and collects
individually identifiable sensitive information about illicit drug
use by surveying college students. The data is stored on a
laptop computer that is password protected. The laptop is
stolen from the investigator’s car.
Is this reportable to the IRB as a UP?
Unanticipated Problems - Examples:
55. An Investigator is conducting a psychology study
evaluating decision making and response times when
persons are listening to music at various decibel levels. In
order to perform the study, participants are placed in a
small, windowless, soundproof booth. The IRB-approved
protocol and consent form describe claustrophobic
reactions as one of the research risks. The 12th subject
enrolled in the research experiences significant
claustrophobia, resulting in the subject withdrawing from
the study.
55
Reporting Non-Safety Information to the IRB
Unanticipated Problems - Examples:
Is this reportable to the IRB as a UP?
56. 56
Reporting Non-Safety Information to the IRB
NO
An Investigator is conducting a psychology study
evaluating decision making and response times when
persons are listening to music at various decibel levels. In
order to perform the study, participants are placed in a
small, windowless, soundproof booth. The IRB-approved
protocol and consent form describe claustrophobic
reactions as one of the research risks. The 12th subject
enrolled in the research experiences significant
claustrophobia, resulting in the subject withdrawing from
the study.
Unanticipated Problems - Examples:
Is this reportable to the IRB as a UP?
57. 57
Reporting Non-Safety Information to the IRB
Is this reportable to the IRB as a UP?
As a result of a processing error by a pharmacy
technician, a subject enrolled in a multi-center
clinical trial receives a dose of an experimental
agent that is 10-times higher than the dose dictated
by the IRB-approved protocol. While the dosing
error increased the risk of toxic manifestations of
the experimental agent, the subject experienced no
detectable harm or adverse effect after an
appropriate period of careful observation.
Unanticipated Problems - Examples:
58. 58
Reporting Non-Safety Information to the IRB
YES
Is this reportable to the IRB as a UP?
As a result of a processing error by a pharmacy
technician, a subject enrolled in a multi-center
clinical trial receives a dose of an experimental
agent that is 10-times higher than the dose dictated
by the IRB-approved protocol. While the dosing
error increased the risk of toxic manifestations of
the experimental agent, the subject experienced no
detectable harm or adverse effect after an
appropriate period of careful observation.
Unanticipated Problems - Examples:
59. Recommended Practices for Reporting Non-Safety Information
For multi-center or single-center:
Generally, UPs that are not an adverse
event (i.e. non-safety related) are
typically site or investigator specific
Therefore, it makes more sense for the
investigator, not the sponsor, to report
the UP to the IRB
The investigator can arrange with IRB in
what format to report
59
60. Recommended Practices for Reporting Non-Safety Information
60
(continued)
Report UPs “promptly”
to the IRB “Promptly” is generally
considered 10 business days,
which is supported in the FDA’s
guidance on reporting to the IRB
This 10-day timeframe exists whether there is an
arrangement for the sponsor to submit on behalf of the
IRB or whether the investigator is responsible for
submitting to the IRB
TIMING of Reporting to the IRB
61. Recommended Practices for Reporting Safety Information
61
(continued)
• What to report
• Whether to report
• How to report
• When to report
QUESTIONS ABOUT:
CONTACT the
63. Key Take Aways
63
• Know where the obligations to report to the IRB originate
• Understand the term “Unanticipated Problem” (UP) and its three
criteria: Unexpected, Related, Greater Risk of Harm
• Understand the terms SUSAR and UADE, know their criteria, and
know that these are UPs that require reporting to the IRB
• Understand that there are UPs that are not safety‐related that must
be reported to the IRB
• Know how and in what timeframe to report to the IRB
• If there are ever any questions relating to reporting to the IRB, talk to
your IRB. The IRB is a resource!
64. • You may submit questions through our webinar
survey
• Mitchell E. Parrish, JD, RAC,CIP
– mparrish@quorumreview.com
– www.linkedin.com/in/mitchellparrish/
• Quorum Client Relations
– ClientRelations@QuorumReview.com
• We will do our best to follow-up individually or
answer your questions in the Q&A we post on our
website
QUESTIONS?
64
65. Webinar Follow-Up
• The webinar Recording, Slide Deck,
and Q&A will be posted on our website
• We will email you a link to view these
items as they become available
• We value your opinion – please take our
SURVEY and provide us with feedback
65