FDA SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) CLINICAL SECTION CHECKLIST OFFICE OF DEVICE EVALUATION
|
|
- Gabriella Murphy
- 5 years ago
- Views:
Transcription
1 FDA SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) CLINICAL SECTION CHECKLIST OFFICE OF DEVICE EVALUATION Note to FDA PMA Reviewers: The Summary of Safety and Effectiveness (SSED) is a document mandated by the Food, Drug and Cosmetic Act subparagraph 520(h)(1)(A) to be publicly available upon issuance of an approval order of a premarket approval application (PMA). The SSED is applicable for all original PMAs and panel-track supplements. It is an FDA document intended to present a reasoned, objective, and balanced summary of the scientific evidence, both positive and negative, that served as the basis of the decision to approve or deny the PMA. There can be no claims in the SSED that are unsubstantiated by the clinical results of the PMA clinical study(ies). The SSED is not a marketing document, and should not contain marketing/advertising language. NOTE: This checklist contains the essential elements that should, at minimum, be included in the clinical section of the SSED. Additional instructions or examples of what should be included under each topic heading are indicated by italicized text. This document is intended to provide general recommendations for writing the clinical portion of the SSED. However, there will be exceptions, as well as devices that will require additional sections. 1
2 SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) I. SUMMARY OF PRIMARY CLINICAL STUDY(IES) Provide a definition of terms such as pilot and pivotal. If there are multiple studies, provide a table with all of the studies and their major characteristics EXAMPLE: Clinical Study Study Design Objective Pilot/Feasibility Number of Sites Number of Subjects (Include enrolled, evaluable and lost to follow-up, etc.) Pivotal Continued Access Multi-center, prospective, randomized, controlled clinical trial Single-arm multi-center study Evaluate the safety and effectiveness of the DEVICE Continue to gather additional safety and effectiveness data XX randomized subjects enrolled/treated YY nonrandomized subjects enrolled/treated AA subjects enrolled/treated; data available for BB subjects enrolled/treated as of DATE A. Pivotal Clinical Study Design The clinical study that formed the basis for FDA s finding that [device] is safe and effective for its intended use was a [include all that apply, such as: prospective, multicenter, one/two-arm, cohort study, randomized, controlled, objective performance criteria (OPC), (un)masked, etc.] clinical study. Major design characteristics: level of masking (e.g., double-masked, partially-masked, open-label), type of controls, duration of study, method of allocation to treatment groups (e.g., randomization), and treatment arms. Clinical Endpoints Safety (Include primary safety endpoints and secondary safety endpoints--include only those that are hypothesis driven, and clinically meaningful) Example: The primary safety endpoint was measured at Y months Key secondary endpoints such as Q, R, S were selected to buttress findings of the primary endpoint and lend consistency to trial results. These endpoints were measured at A, B, and C days, weeks, months, years, respectively. 2
3 Effectiveness (Include primary effectiveness endpoints and secondary effectiveness endpoints--include only those that are hypothesis-driven, and clinically meaningful) Example: The primary effectiveness endpoint was measured at X months. Key secondary endpoints such as Q, R, S were selected to buttress findings of the primary endpoint and lend consistency to trial results. These endpoints were measured at A, B, and C days, respectively. Success/failure criteria This should include a definition of individual patient success, as well as for the study overall. The definition of success should include a targeted value at a specific point in time. It must be specific and quantifiable. Pre-specified statistical analysis plan: study hypothesis(es) comparator (with justification) o OPC? methodology e.g., Frequentist, Bayesian, Adaptive sample size justification statistical test (e.g. superiority, non-inferiority) o delta if non-inferiority method for how missing data will be imputed assumptions External evaluation groups: core laboratory use independent evaluators Data Monitoring Committee (e.g. DSMB) Study design discussion: This design was thought to be appropriate because: Explanation of safety and effectiveness endpoints, control, duration of follow-up, etc. (May use clinical IDE template when available) Explain how thinking on study design evolved and/or changed, if appropriate. Clinical Inclusion and Exclusion Criteria Enrollment in the [name] study was limited to patients who met the following selection criteria Inclusion Exclusion 3
4 Brief Summary of Treatment and Follow-Up Protocols Follow-up schedule and evaluations Clinical assessments occurred at baseline, operative/discharge and postoperative intervals at X wks, X months and X years. [A detailed chart describing follow-up assessments and time points can be provided here] Prospectively defined subgroup evaluations can be provided here B. Accountability of PMA Cohort At the time of database lock, of N subjects enrolled in PMA study, %(n) subjects are available for analysis at the completion of the study, the xx month/year post-operative visit (final visit evaluated for safety and effectiveness as the basis for the PMA submission). Include an accountability summary table or patient accountability tree. This section should clearly define which set of patients is what analysis cohort (e.g., the intent-totreat cohort, the per protocol cohort, evaluable cohort). C. Study Population Demographics and Baseline Parameters The demographics of the study population were as follows: Include tables showing the proportion of subjects of various races, age distribution, gender, and comorbidities Assessment of appropriateness of study demographics: Identification of demographic groups under or over represented in the study population D. Safety and Effectiveness Results Safety Results Begin with a declarative sentence regarding whether the statistical hypothesis for the primary safety endpoint was met. The analysis of safety was based on the treated (e.g. implanted, ablated) cohort of xxx patients/procedures, etc available for the xxx month evaluation. The key safety outcomes for this study are presented below in tables xx to xx. Adverse effects are reported in tables xx to xx. 4
5 Adverse effects that occurred in the PMA clinical study: List all adverse effects observed during the PMA clinical study, with incidence rate and number, in descending order of clinical importance, as determined by their severity and/or incidence. It is helpful to present these data in tabular form with a comparative column listing the adverse events that occurred in the control treatment group. Specifics of device or procedure related events should be further discussed in the clinical studies section. You may choose a cut-off such as events occurring at a rate > 1% or >5%. However, for novel devices with small studies, including adaptive and bayesian designs, consider the clinical importance and device relatedness of low rates of occurrence in a larger proportion of the general population with the disease being treated. Consider whether the lack of effectiveness as manifested by worsening of the original condition should or should not be counted as an adverse event. This should be evaluated on a case by case basis and may be condition specific. Include all tables deemed important in the determination of device safety. A short narrative that describes significant findings should be associated with each table. A time course of the occurrence of adverse events as compared to the control treatment is recommended in relation to the initial treatment [Option for PMA Supplements where updating SSED is warranted: Since PMA cohort tends to be smaller: It should be noted that the safety of the device for [indication] was not based on this sample alone, but rather on all the available for the device to date. The safety data from this study were for confirmatory purposes.] Include any additional observations by the clinical reviewer. If adverse events led to any device design modifications during the PMA clinical study, they should be described briefly. Identify the cause of any device failures and the number of occurrences. Effectiveness Results Begin with a declarative sentence regarding whether the statistical hypothesis for the primary effectiveness endpoint was met. The analysis of effectiveness was based on the xxx evaluable at the xxx-month timepoint. Key effectiveness outcomes are presented in tables xx to xx. Continue with FDA s clinical assessment as to the acceptability of these rates. Include all tables on all cohorts deemed important in the determination of device effectiveness. 5
6 Subgroup Analyses The following preoperative characteristics were evaluated for potential association with outcomes: (e.g., gender, site, age). (Describe associations found with outcomes.) II. SUMMARY OF SUPPLEMENTAL CLINICAL INFORMATION Note: Only include discussion when information contributed to FDA s decision in a major way. This section should describe results for other information considered such as Continued Access, European, or other Outside-the-US (OUS) clinical data, as well as potentially relevant subsets of the study cohort of potential interest to physicians and/or patients (e.g., pediatric, diabetic or other disease/condition of interest, ethnicity, and sex). Include relevant covariate analyses, if performed, and why they were done. III. OVERALL CONCLUSIONS FROM CLINICAL DATA Should include a discussion of the overall clinical risk and benefit analysis decision. If applicable, your conclusions should consider the panel deliberations and conclusions and FDA s post-panel actions Implied Claims If applicable, should consider implied claims and advertising and promotional claims. SSED vs. Device Labeling Although the SSED is a different document and has a different purpose compared to labeling, the clinical trials data will have an important impact on both the SSED and labeling. In writing the SSED, bear in mind specific details of labeling that were influenced by the clinical outcomes data and provide a discussion of these outcomes and how they affected device labeling. The following examples illustrate situations where the SSED should explain important details of labeling: Off-Label Use During its review, FDA may seek a statement in the labeling that there is a lack of evidence that a device is effective for an off-label use or indication. The SSED should contain an explanation of the basis for such limitations. 6
7 Contraindications Based on Clinical Trials Data If any of the clinical trials data led to a requirement for a Contraindication in the device labeling, provide a thorough explanation in the SSED of what led to the Contraindication. Special Patient Populations Limitations on the usage of a device, based on the clinical data, may be necessary for various reasons including lack of long-term safety and effectiveness data, lack of safety and effectiveness data for specific patient populations (e.g., pregnant women), growth processes still occurring in the body, and anatomical or physiological limitations on the effectiveness of the device. If the clinical data indicate that safety and effectiveness of the device for use in specific patient populations have not been established, provide a discussion of these patient populations in the SSED. Such information is available in the "Indications for Use" section of the labeling. Similarly, the "Precautions" section of the labeling will generally include information about populations for whose use the device s safety and effectiveness have not been established. If use of the device in a certain patient population is associated with a specific hazard, the hazard shall be described in the SSED. This information should be available in the applicable section - Precautions, Warnings, or Contraindications sections of the labeling. 7
8 Additional Review Tips Helpful Hints General Avoid unsubstantiated claims often included in the draft SSED submitted by the applicant in the PMA. Words or phrases that lack a commonly understood meaning (e.g., imprecise quantitative terms), are not easily defined, are vague, misleading, or promotional in tone should be avoided. Examples include large or small (instead, use actual size or amount), welldesigned (instead, provide specifics about the study design), extensively studied (instead, provide specifics about the database), rapid (instead, specify change/unit time), trend (instead, provide specifics about the outcome), very effective (instead, give the size of the effect), and highly significant (instead, provide the confidence interval). Use only the necessary detail in tables and graphs to summarize large amounts of data that support FDA s decision about the safety and effectiveness of the device. The SSED should not be a rehash of the review memos, but should tell the story of the preclinical and clinical testing in a logical order that led to FDA s decision. Present the data as it is without judgments as to the impact of that data. That information should go into the reviews not the SSED. Number the pages. Tables and Graphs Make sure each is adequately titled and numbered to identify the data summarized. Include the numerator and denominator for ratios and percentages. Include the sample size for each treatment group and the analysis performed to obtain the summarized result. Include baseline data where applicable for comparison. Include footnotes or legends to simplify graphics. Label graph axes with appropriate labels and units of scale. Include p-values and indicate levels of significance reached only if applicable (i.e. prespecified safety and effectiveness analyses with alpha allocation). Clinical and biostatistical reviewers should discuss relevance of p-values in the context of informing for review and use of the product in question. 8
Investigator Initiated Study Proposal Form
Please submit completed form to IISReview@KCI1.com Date Submitted Name & Title Institution Address Phone Number Email Address Principal Investigator / Institution YES NO Multi Center Study Acelity Product(s)
More informationWATCHMAN PROTECT AF Study Rev. 6
WATCHMAN PROTECT AF Study Rev. 6 Protocol Synopsis Title WATCHMAN Left Atrial Appendage System for Embolic PROTECTion in Patients with Atrial Fibrillation (PROTECT AF) Sponsor Atritech/Boston Scientific
More informationNIH NEW CLINICAL TRIAL REQUIREMENTS AND FORMS-E
NIH NEW CLINICAL TRIAL REQUIREMENTS AND FORMS-E HOW DOES THE NIH DEFINE CLINICAL TRIAL AND HOW DO I KNOW IF MY STUDY IS ONE? 01-18-18 A clinical trial is defined by the NIH as a research study in which
More informationMay 16, Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville, MD 20852
701 Pennsylvania Avenue, NW Suite 800 Washington, D.C. 20004 2654 Tel: 202 783 8700 Fax: 202 783 8750 www.advamed.org May 16, 2014 Division of Dockets Management (HFA-305) Food and Drug Administration
More informationMobile Medical Devices Final Project Assignment Submittal of the MMDA 510(k)
Mobile Medical Devices Final Project Assignment Submittal of the MMDA 510(k) [Base upon http://www.fda.gov/medicaldevices/deviceregulationandguidance/howtomarketyourdevice/premarketsubmissions/prem arketnotification510k/ucm142651.htm
More informationDRAFT (Final) Concept Paper On choosing appropriate estimands and defining sensitivity analyses in confirmatory clinical trials
DRAFT (Final) Concept Paper On choosing appropriate estimands and defining sensitivity analyses in confirmatory clinical trials EFSPI Comments Page General Priority (H/M/L) Comment The concept to develop
More informationEFFECTIVE MEDICAL WRITING Michelle Biros, MS, MD Editor-in -Chief Academic Emergency Medicine
EFFECTIVE MEDICAL WRITING Michelle Biros, MS, MD Editor-in -Chief Academic Emergency Medicine Why We Write To disseminate information To share ideas, discoveries, and perspectives to a broader audience
More informationCONSORT 2010 checklist of information to include when reporting a randomised trial*
CONSORT 2010 checklist of information to include when reporting a randomised trial* Section/Topic Title and abstract Introduction Background and objectives Item No Checklist item 1a Identification as a
More informationGuidance Document for Claims Based on Non-Inferiority Trials
Guidance Document for Claims Based on Non-Inferiority Trials February 2013 1 Non-Inferiority Trials Checklist Item No Checklist Item (clients can use this tool to help make decisions regarding use of non-inferiority
More informationAccording to the INDICATIONS AND USAGE section of its FDA-approved product labeling (PI):
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Silver Spring, MD 20993 TRANSMITTED BY FACSIMILE Karen L. Walles, M.S. Assistant Director, Regulatory Affairs 3
More informationLecture 2. Key Concepts in Clinical Research
Lecture 2 Key Concepts in Clinical Research Outline Key Statistical Concepts Bias and Variability Type I Error and Power Confounding and Interaction Statistical Difference vs Clinical Difference One-sided
More informationA Brief Guide to Writing
Writing Workshop WRITING WORKSHOP BRIEF GUIDE SERIES A Brief Guide to Writing Psychology Papers and Writing Psychology Papers Analyzing Psychology Studies Psychology papers can be tricky to write, simply
More informationMigraine: Developing Drugs for Acute Treatment Guidance for Industry
Migraine: Developing Drugs for Acute Treatment Guidance for Industry U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) February 2018
More informationGuidance for Industry Migraine: Developing Drugs for Acute Treatment
Guidance for Industry Migraine: Developing Drugs for Acute Treatment DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Comments and suggestions regarding this draft
More informationResearch Questions and Survey Development
Research Questions and Survey Development R. Eric Heidel, PhD Associate Professor of Biostatistics Department of Surgery University of Tennessee Graduate School of Medicine Research Questions 1 Research
More informationCenters for Medicare and Medicaid Services. National Coverage of Transcatheter Valve Technologies December 2015
Centers for Medicare and Medicaid Services National Coverage of Transcatheter Valve Technologies December 2015 National Coverage Determination (NCD) for Transcatheter Aortic Valve Replacement (TAVR) (20.32)
More informationIntegrating Effectiveness and Safety Outcomes in the Assessment of Treatments
Integrating Effectiveness and Safety Outcomes in the Assessment of Treatments Jessica M. Franklin Instructor in Medicine Division of Pharmacoepidemiology & Pharmacoeconomics Brigham and Women s Hospital
More informationReflection paper on assessment of cardiovascular risk of medicinal products for the treatment of cardiovascular and metabolic diseases Draft
1 2 3 21 May 2015 EMA/CHMP/50549/2015 Committee for Medicinal Products for Human Use (CHMP) 4 5 6 7 Reflection paper on assessment of cardiovascular risk of medicinal products for the treatment of cardiovascular
More informationQA Program Evaluation Research Tool CF-195, Effective
COMPARISON OF THE CHARACTERISTICS OF RESEARCH, QUALITY IMPROVEMENT, AND PROGRAM EVALUATION ACTIVITIES RESEARCH QUALITY IMPROVEMENT PROGRAM EVALUATION COMMENTS INTENT Intent of project is to develop or
More informationTitle: Intention-to-treat and transparency of related practices in randomized, controlled trials of anti-infectives
Author s response to reviews Title: Intention-to-treat and transparency of related practices in randomized, controlled trials of anti-infectives Authors: Robert Beckett (rdbeckett@manchester.edu) Kathryn
More informationPage 1 of 18 Volume 01 Page 1
Response to Vagus Nerve Stimulation (VNS) Therapy Treatment-Resistant Depression (TRD) Indication Not Approvable Letter from the United States Food and Drug Administration (FDA), Dated August 11, 2004
More informationStandards for the reporting of new Cochrane Intervention Reviews
Methodological Expectations of Cochrane Intervention Reviews (MECIR) Standards for the reporting of new Cochrane Intervention Reviews 24 September 2012 Preface The standards below summarize proposed attributes
More informationHandheld Radiofrequency Spectroscopy for Intraoperative Assessment of Surgical Margins During Breast-Conserving Surgery
7.01.140 Handheld Radiofrequency Spectroscopy for Intraoperative Assessment of Surgical Margins During Breast-Conserving Surgery Section 7.0 Surgery Subsection Description Effective Date November 26, 2014
More informationThe Research Roadmap Checklist
1/5 The Research Roadmap Checklist Version: December 1, 2007 All enquires to bwhitworth@acm.org This checklist is at http://brianwhitworth.com/researchchecklist.pdf The element details are explained at
More informationIndividual Study Table Referring to Part of the Dossier. Page:
2. SYNOPSIS Title of Study: A comparative study of the pharmacokinetic/pharmacodynamic and safety profiles of extended release, regular release and placebo during a 12 hour observation in post-extraction
More information1. Introduction Overview Organization of Executive Summary
Executive Summary and Discussion of the Vagus Nerve Stimulation (VNS) Therapy Depression Indication Clinical Data (Updated to Include Information from Deficiency Letter Response) Prepared By: Richard L.
More informationClass II Special Controls Guidance Document: Intraoral Devices for Snoring and/or Obstructive Sleep Apnea; Guidance for Industry and FDA
Class II Special Controls Guidance Document: Intraoral Devices for Snoring and/or Obstructive Sleep Apnea; Guidance for Industry and FDA Document issued on: November 12, 2002 This document supersedes the
More informationCONSULTANT PHYSICIAN v SANOFI
CASE AUTH/2477/2/12 CONSULTANT PHYSICIAN v SANOFI Conduct of representative A consultant physician alleged that at a hospital diabetes meeting a Sanofi representative had been unprofessional in that she
More informationWeb Meeting Sep 20, Presented by: Kimberly Belsky, DIA AdPromo WG Chair DIA, Inc. All Rights Reserved.
OPDP Warning Letter Posted Sep 2017 FDA Draft Guidance Medical Product Communications That Are Consistent With the FDA-Required Labeling Q&A s (Issued January 2017) Web Meeting Sep 20, 2017 Presented by:
More informationEuropean Federation of Statisticians in the Pharmaceutical Industry (EFSPI)
Page 1 of 14 European Federation of Statisticians in the Pharmaceutical Industry (EFSPI) COMMENTS ON DRAFT FDA Guidance for Industry - Non-Inferiority Clinical Trials Rapporteur: Bernhard Huitfeldt (bernhard.huitfeldt@astrazeneca.com)
More informationDuragesic has the potential for abuse. The Drug Abuse and Dependence section of the PI states, in pertinent part:
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Rockville, MD 20857 TRANSMITTED BY FACSIMILE Ajit Shetty, M.D. CEO Janssen Pharmaceutics, Inc. 1125 Trenton-Harbourton
More informationTitle 1 Descriptive title identifying the study design, population, interventions, and, if applicable, trial acronym
SPIRIT 2013 Checklist: Recommended items to address in a clinical trial protocol and related documents* Section/item Item No Description Addressed on page number Administrative information Title 1 Descriptive
More informationهيئة التقييس لدول مجلس التعاون لدول الخليج العربية
هيئة التقييس لدول مجلس التعاون لدول الخليج العربية GCC STANDARDIZATION ORGANIZATION (GSO) Final Draft GSO 05 FDS 1366 / 2016 اشت ارطات عامة لتداول األغذية المستعملة ألغ ارض طبية خاصة General Requirements
More informationAppendix A: NAPLaN Reading Skills by Proficiency Band
Appendix A: NAPLaN Reading Skills by Proficiency Band NAPLaN Comprehension Skills by Proficiency Band PB Finds clearly stated information in the first sentence of an illustrated information text. 1 Locates
More informationDelfini Evidence Tool Kit
General 1. Who is sponsoring and funding the study? What are the affiliations of the authors? Study Design Assessment Internal Validity Assessment Considerations: This can be helpful information and is
More informationMarket Access CTR Summary
Market Access CTR Summary Study No.: BEL114246 Title: Efficacy of Belimumab Treatment in a Subpopulation of Systemic Lupus Erythematosus (SLE) Patients: A Pooled Analysis of the HGS1006-C1056 (BLISS-52)
More informationPre-marketing Assessment of Drug Safety
Pre-marketing Assessment of Drug Safety Judith A. Racoosin, MD, MPH Safety Team Leader Division of Neurology Products/Division of Psychiatry Products (formerly the Division of Neuropharmacological Drug
More informationTRANSMITTED BY FACSIMILE
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Silver Spring, MD 20993 TRANSMITTED BY FACSIMILE Kirsten Dale Manager, Regulatory Affairs Promotion/Advertising
More informationThe MASCC Guidelines Policy
The MASCC Guidelines Policy Recommendations for MASCC Guideline Construction and the Endorsement of Externally Generated Guidelines Preamble MASCC recognizes that providing supportive care facilitates
More informationEPF s response to the European Commission s public consultation on the "Summary of Clinical Trial Results for Laypersons"
EPF s response to the European Commission s public consultation on the "Summary of Clinical Trial Results for Laypersons" August 2016 This document received funding under an operating grant from the European
More informationCochrane Breast Cancer Group
Cochrane Breast Cancer Group Version and date: V3.2, September 2013 Intervention Cochrane Protocol checklist for authors This checklist is designed to help you (the authors) complete your Cochrane Protocol.
More informationThe EU PIP - a step in Pediatric Drug Development. Thomas Severin Bonn,
The EU PIP - a step in Pediatric Drug Development Thomas Severin Bonn, 13.01.2009 Agenda Implications for Industry Company Preparation Time of PIP Submission Content of the PIP The PIP Process and first
More informationStatistical Analysis Plan RH01649 Version Document Identifier Effective Date eldo_clinical_doc Reason For Issue
STATISTICAL ANALYSIS PLAN FOR PROTOCOL RH01649 A Study to Assess Efficacy over Placebo and Speed of Onset of Pain Relief of New Panadol Extra as Compared to Ibuprofen in Episodic Tension Headache BIOSTATISTICS
More informationForward Looking Statements and Further Information
JANUARY 2015 [ 1 ] Forward Looking Statements and Further Information SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS This presentation contains forward-looking statements. All statements other than
More informationFundamental Clinical Trial Design
Design, Monitoring, and Analysis of Clinical Trials Session 1 Overview and Introduction Overview Scott S. Emerson, M.D., Ph.D. Professor of Biostatistics, University of Washington February 17-19, 2003
More informationUpdate from the Tryton IDE study
Update from the Tryton IDE study Maciej Lesiak EBC 2015 - Athens The Tryton Bifurcation Trial: A randomized comparison of a provisional one-stent vs. a dedicated two-stent strategy for true bifurcation
More informationPhase 2b/3 Topline Trial Results
Phase 2b/3 Topline Trial Results RP-G28 For the Treatment of Lactose Intolerance March 2017 Forward - Looking Statement To the extent that statements contained in this presentation are not descriptions
More informationCONSORT 2010 checklist of information to include when reporting a randomised trial*
Supplemental Figures for: Ramosetron Versus Ondansetron in Combination with Aprepitant and Dexamethasone for the Prevention of Highly Emetogenic Chemotherapy-induced Nausea and Vomiting: A Multicenter,
More informationISA 540, Auditing Accounting Estimates, Including Fair Value Accounting Estimates, and Related Disclosures Issues and Task Force Recommendations
Agenda Item 1-A ISA 540, Auditing Accounting Estimates, Including Fair Value Accounting Estimates, and Related Disclosures Issues and Task Force Recommendations Introduction 1. Since the September 2016
More informationChapter 5 Analyzing Quantitative Research Literature
Activity for Chapter 5 Directions: Locate an original report of a quantitative research, preferably on a topic you are reviewing, and answer the following questions. 1. What characteristics of the report
More informationLast Name First name Academic degrees. Professional titles and/or work position within your home institution
Date received stamp ETHICS AND RESEARCH APPLICATION FORM Kenyatta National Hospital/University of Nairobi KEMRI CENTERS ETHICS RESEARCH COMMITTEE Application Number Submit three copies of this form (including
More informationZITHROMAX (AZITHROMYCIN) SNDA H.3 CLINICAL TRIALS RELEVANT TO THE CLAIM STRUCTURE TABLE OF CONTENTS H.3.A. GENERAL APPROACH TO EVALUATION...
ZITHROMAX (AZITHROMYCIN) SNDA H.3 CLINICAL TRIALS RELEVANT TO THE CLAIM STRUCTURE TABLE OF CONTENTS H.3.A. GENERAL APPROACH TO EVALUATION...2 H.3.A.1 Efficacy (Pfizer IND Studies)...2 H.3.A.1.A Summary
More informationClinicalTrials.gov "Basic Results" Data Element Definitions (DRAFT)
ClinicalTrials.gov "Basic Results" Data Element Definitions (DRAFT) January 9, 2009 * Required by ClinicalTrials.gov [*] Conditionally required by ClinicalTrials.gov (FDAAA) May be required to comply with
More informationPlanning and Carrying Out an Investigation. Name:
Planning and Carrying Out an Investigation Name: Part A: Asking Questions (NGSS Practice #1) Topic or Phenomenon: 1. What am I wondering? What questions do I have about the topic/phenomenon? (why, when,
More informationISPOR Task Force Report: ITC & NMA Study Questionnaire
INDIRECT TREATMENT COMPARISON / NETWORK META-ANALYSIS STUDY QUESTIONNAIRE TO ASSESS RELEVANCE AND CREDIBILITY TO INFORM HEALTHCARE DECISION-MAKING: AN ISPOR-AMCP-NPC GOOD PRACTICE TASK FORCE REPORT DRAFT
More informationARTS IN MOTION CHARTER SCHOOL 7th Grade ELA CURRICULUM MAP
ARTS IN MOTION CHARTER SCHOOL 7th Grade ELA CURRICULUM MAP Projects Essential Questions Enduring Understandings Cognitive Skills CCSS Final Product Cultural Narratives Project Why is it important to tell
More informationSystematic reviews and meta-analyses of observational studies (MOOSE): Checklist.
Systematic reviews and meta-analyses of observational studies (MOOSE): Checklist. MOOSE Checklist Infliximab reduces hospitalizations and surgery interventions in patients with inflammatory bowel disease:
More informationCHECKLIST FOR EVALUATING A RESEARCH REPORT Provided by Dr. Blevins
CHECKLIST FOR EVALUATING A RESEARCH REPORT Provided by Dr. Blevins 1. The Title a. Is it clear and concise? b. Does it promise no more than the study can provide? INTRODUCTION 2. The Problem a. It is clearly
More informationGuidance - IDE Early/Expanded Access for Devices
Guidance - IDE Early/Expanded Access for Devices An unapproved medical device may normally only be used on human subjects through an approved clinical study in which the subjects meet certain criteria
More information2/17/2018. Prof. Steven S. Saliterman Department of Biomedical Engineering, University of Minnesota
Department of Biomedical Engineering, University of Minnesota http://saliterman.umn.edu/ FDA Authority Medical Device Act of 1976 FDA Modernization Act of 1997 Federal Food, Drug and Cosmetic Act (FFDCA)
More informationProf. Steven S. Saliterman. Department of Biomedical Engineering, University of Minnesota
Department of Biomedical Engineering, University of Minnesota http://saliterman.umn.edu/ FDA Authority Medical Device Act of 1976 FDA Modernization Act of 1997 Federal Food, Drug and Cosmetic Act (FFDCA)
More informationAbout Reading Scientific Studies
About Reading Scientific Studies TABLE OF CONTENTS About Reading Scientific Studies... 1 Why are these skills important?... 1 Create a Checklist... 1 Introduction... 1 Abstract... 1 Background... 2 Methods...
More informationStudy Summary Study THS-PBA-02-US
Page 1 Study Summary Study THS-PBA-02-US Study Title: Sponsor: Qualitative Study to Develop THS 2.2 Hypothetical Product Messages Philip Morris International Management S.A. Avenue de Rhodanie, 50 1007
More informationUsing Health IT to Support Oral Health Integration: Dealing with Common Barriers. Jeff Hummel, MD, MPH Qualis Health November 5, 2015
Using Health IT to Support Oral Health Integration: Dealing with Common Barriers Jeff Hummel, MD, MPH Qualis Health November 5, 2015 Goals for this Session Understand 3 aspects of oral health information
More informationSafeguarding public health Subgroup Analyses: Important, Infuriating and Intractable
Safeguarding public health Subgroup Analyses: Important, Infuriating and Intractable The views expressed herein are not necessarily those of MHRA, EMA, EMA committees or their working parties. Rob Hemmings
More informationReviewer No. 1 checklist for application of: inclusion of Nifurtimox + eflornithine in the WHO Essential Medicines List
Reviewer No. 1 checklist for application of: inclusion of Nifurtimox + eflornithine in the WHO Essential Medicines List (1) Have all important studies that you are aware of been included? No additional
More informationXARACOLL Phase 3 Results Webcast. MATRIX 1 and MATRIX 2 Clinical Trials May 25, 2016
XARACOLL Phase 3 Results Webcast MATRIX 1 and MATRIX 2 Clinical Trials May 25, 2016 Forward Looking Statements This presentation contains forward-looking statements about our ongoing development of XARACOLL
More informationWARNING LETTER. Robert Essner Chairman and Chief Executive Officer Wyeth Pharmaceuticals Inc. P.O. Box 8299 Philadelphia, PA
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Rockville, MD 20857 TRANSMITTED BY FACSIMILE Robert Essner Chairman and Chief Executive Officer P.O. Box 8299 Philadelphia,
More informationHandheld Radiofrequency Spectroscopy for Intraoperative Assessment of Surgical Margins During Breast-Conserving Surgery
Last Review Status/Date: December 2014 Page: 1 of 6 Intraoperative Assessment of Surgical Description Breast-conserving surgery as part of the treatment of localized breast cancer is optimally achieved
More informationFDA Perspective. Carolyn Y. Neuland, Ph.D.
FDA Perspective Carolyn Y. Neuland, Ph.D. Chief Gastroenterology and Renal Devices Branch Division of Reproductive, Gastro-Renal and Urological Devices Center for Devices and Radiological Health Device
More informationOther Designs. What Aids Our Causal Arguments? Time Designs Cohort. Time Designs Cross-Sectional
Statistics in & Things to Consider Your Proposal Bring green folder of readings and copies of your proposal rough draft (one to turn in) Other Designs November 26, 2007 1 2 What Aids Our Causal Arguments?
More informationOECD QSAR Toolbox v.4.2. An example illustrating RAAF scenario 6 and related assessment elements
OECD QSAR Toolbox v.4.2 An example illustrating RAAF scenario 6 and related assessment elements Outlook Background Objectives Specific Aims Read Across Assessment Framework (RAAF) The exercise Workflow
More informationMEASURING PATIENT AND OBSERVER-REPORTED OUTCOMES (PROS AND OBSROS) IN RARE DISEASE CLINICAL TRIALS - EMERGING GOOD PRACTICES TASK FORCE
MEASURING PATIENT AND OBSERVER-REPORTED OUTCOMES (PROS AND OBSROS) IN RARE DISEASE CLINICAL TRIALS - EMERGING GOOD PRACTICES TASK FORCE Outline I. Introduction: Current environment of clinical research
More informationClinical Study Synopsis
Clinical Study Synopsis This Clinical Study Synopsis is provided for patients and healthcare professionals to increase the transparency of Bayer's clinical research. This document is not intended to replace
More informationTRANSLATING RESEARCH INTO PRACTICE
TRANSLATING RESEARCH INTO PRACTICE New York University Tbilisi, July 15-19, 2013 Allison Squires, PhD, RN Adam Sirois, MPH SESSION 2: QUESTIONS, CONCEPTS, & THEORIES Goals for Session t1 Describe the characteristics
More informationIt is crucial to follow specific steps when conducting a research.
Research is the systematic collection, analysis and interpretation of data to answer a certain question or solve a problem. It is crucial to follow specific steps when conducting a research. Choose a problem
More informationA response by Servier to the Statement of Reasons provided by NICE
A response by Servier to the Statement of Reasons provided by NICE Servier gratefully acknowledges the Statement of Reasons document from NICE, and is pleased to provide information to assist NICE in its
More informationTips for Writing a Research Paper in APA format:
Tips for Writing a Research Paper in APA format: Basics: A research paper (especially one that requires APA style) is different than a term paper, a creative writing paper, a composition-style paper, or
More informationHolt McDougal Avancemos!, Level correlated to the. Crosswalk Alignment of the National Standards for Learning Languages
Holt McDougal Avancemos!, Level 2 2013 correlated to the Crosswalk Alignment of the National Standards for Learning Languages with the Common Core State Standards READING 1. Read closely to determine what
More informationKeyzilen TM Program Update
Keyzilen TM Program Update October 11, 2016 Forward-looking Statements This presentation and the accompanying oral commentary contain forward-looking statements that involve substantial risks and uncertainties.
More informationQuality ID #257 (NQF 1519): Statin Therapy at Discharge after Lower Extremity Bypass (LEB) National Quality Strategy Domain: Effective Clinical Care
Quality ID #257 (NQF 1519): Statin Therapy at Discharge after Lower Extremity Bypass (LEB) National Quality Strategy Domain: Effective Clinical Care 2018 OPTIONS FOR INDIVIDUAL MEASURES: REGISTRY ONLY
More informationUsing Statistical Principles to Implement FDA Guidance on Cardiovascular Risk Assessment for Diabetes Drugs
Using Statistical Principles to Implement FDA Guidance on Cardiovascular Risk Assessment for Diabetes Drugs David Manner, Brenda Crowe and Linda Shurzinske BASS XVI November 9-13, 2009 Acknowledgements
More informationEMEA WORKING PARTY ON HERBAL MEDICINAL PRODUCTS
The European Agency for the Evaluation of Medicinal Products Evaluation of Medicines for Human Use 25 October 1999 EMEA/HMPWP/23/99 EMEA WORKING PARTY ON HERBAL MEDICINAL PRODUCTS UPDATED DRAFT POINTS
More informationNOVO NORDISK v SANOFI-AVENTIS
CASE AUTH/2152/8/08 NOVO NORDISK v SANOFI-AVENTIS Promotion of Lantus Novo Nordisk complained about a mailer and two leavepieces produced by Sanofi-Aventis that promoted Lantus (insulin glargine). Novo
More informationBelow is the indication and summary of the most serious and most common risks associated with the use of Naftin Cream, 2%. 2
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Silver Spring, MD 20993 TRANSMITTED BY FACSIMILE Misty M. D Ottavio, Senior Manager Regulatory Affairs 4215 Tudor
More informationDoing Double Duty Collecting Data for FDA and CMS in the Same Study
Doing Double Duty Collecting Data for FDA and CMS in the Same Study Gregory de Lissovoy, PhD MEDICAL DEVICE REGULATORY AND COMPLIANCE CONGRESS March 30, 2006 Overview How FDA and CMS view evidence from
More informationInnovations In Neuromodulation. Maged Guirguis, MD Director Of Research Pain Management
Innovations In Neuromodulation Maged Guirguis, MD Director Of Research Pain Management 1 2 Pain Pathway 3 Gate Theory In the dorsal horn (where pain signals relay), there is a gate that opens and closes
More informationBEST PRACTICE CHANGE CONTROL : DECIDING WHEN TO SUBMIT A 510(K) FOR A DEVICE CHANGE. Yuan Xu 18- JAN- 2018
BEST PRACTICE CHANGE CONTROL : DECIDING WHEN TO SUBMIT A 510(K) FOR A DEVICE CHANGE Yuan Xu 18- JAN- 2018 Background AGENDA What is Medical Device? What is 510(k)? Principles of best practices of device
More informationThe proposed rule is significant, and the requirements and exceptions are complex. Key provisions of the proposal are described below.
ADVISORY Food & Drug FDA ISSUES PROPOSED RULE TO ESTABLISH A UNIQUE DEVICE IDENTIFICATION SYSTEM FOR MEDICAL DEVICES July 16, 2012 On July 11, 2012, the Food and Drug Administration (FDA) published in
More informationWARNING LETTER DEPARTMENT OF HEALTH & HUMAN SERVICES TRANSMITTED BY FACSIMILE
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Rockville, MD 20857 TRANSMITTED BY FACSIMILE Carole S. Ben-Maimon, M.D. President and Chief Operating Officer One
More informationThe Study of Life. Before You Read. Science Journal
The Study of Life Before You Read Use the What I Know column to list the things you know about biology. Then list the questions you have about biology in the What I Want to Find Out column. K W L What
More informationPerformance Improvement Project Implementation & Submission Tool
PLANNING TEMPLATE Performance Improvement Project Implementation & Submission Tool INTRODUCTION & INSTRUCTION This tool provides a structure for development and submission of Performance Improvement Projects
More informationWARNING LETTER. According to the Indications and Usage section of the FDA approved product labeling (PI):
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Rockville, MD 20857 TRANSMITTED BY FACSIMILE David E.I. Pyott President and Chief Executive Officer PO Box 19534
More informationCarotid artery stents and embolic protection
Regulation of Carotid Artery Stents and Embolic Protection Devices in the United States A history of, and perspectives on, FDA regulation of carotid stents and associated embolic protection devices over
More informationPractical guidance for applicants on the submission of applications on food additives, food enzymes and food flavourings
Version 2 Updated on 29/11/2011 Practical guidance for applicants on the submission of applications on food additives, food enzymes and food flavourings Valid as of: 11 September 2011 Disclaimer: This
More informationUNIVERSITY OF CHICAGO MEDICINE & INSTITUTE FOR TRANSLATIONAL MEDICINE COMMUNITY BENEFIT FY 2016 ADULT DIABETES GRANT GUIDELINES
UNIVERSITY OF CHICAGO MEDICINE & INSTITUTE FOR TRANSLATIONAL MEDICINE COMMUNITY BENEFIT FY 2016 ADULT DIABETES GRANT GUIDELINES The following grant guidelines will help you prepare your grant proposal
More informationSkills (Students will do): Determine word meanings Use context clues Acknowledge the need to stop and look for context clues.
Benchmark#: R.8.1.3.1 determines meaning of words or phrases using context clues (e.g., definitions, restatements, examples, descriptions, comparison-contrast, clue words, cause-effect) from sentences
More informationGuidance on colleague and patient questionnaires
Guidance on colleague and patient questionnaires 2 Revalidation is the process by which doctors must demonstrate to the General Medical Council (GMC), normally every five years, that they are up to date
More information