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Draft Guidance for Indu

Evaluation of Sex Dierences in Medical Device Clinical
Studies
This guidance document is being distributed for comment purposes
only.
Document issued on: December 19, 2011
Preface
Table of Contents
I. 
II. 
III. 
 
! "##
$ #%&'()*)+'+
, !+))+'+
IV. ""-.-##"
 #
$ +/+0+1+)
+))++2
, 3)+++0&+33)%+2
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Devices and Radiological Health

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4 &++05,,+2
! .
$ +/+0+1+)
+))++2
, 3)+++0&+33)%+2
4 &++05,,+2
V. ""6##
 #"
$ +/+0+1+)
+))++2
, 3)+++0&+33)%+2
4 &++05,,+2
! 6
2. "".6"
""#!#.
 ##"".7!#8
6"!
$ +/+0+1+)
+))++2
, 3)+++0&+33)%+2
4 &++05,,+2
! 6"0-2
$ 3)+++0&+33)%+2
, &++05,,+2
Draft Guidance: Evaluation of Sex Dierences in Medical Device
Clinical Studies
This draft guidance, when nalized, will represent the Food and
Drug Administration's (FDA's) current thinking on this topic. It does
not create or confer any rights for or on any person and does not

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Draft Guidance for Industry and Food and Drug Administration Evaluation of Sex Differences in Medical Device Clinical Studies This guidance document is being distributed for comment purposes only. Document issued on: December 19, 2011 Preface Table of Contents I. INTRODUCTION II. SCOPE III. FOREWORD A. WHY CONSIDER SEX DIFFERENCES? B. PARTICIPATION OF WOMEN IN CLINICAL STUDIES 1. Lack of Available Data for Women 2. Barriers to Enrollment of Women IV. RECOMMENDATIONS FOR ACHIEVING REPRESENTATIVE ENROLLMENT A. CONSIDERATION OF POTENTIAL SEX DIFFERENCES 1. For New or Ongoing Studies (IDE study design/early enrollment stage) 2. For Completed Studies (marketing application stage) 3. For Postmarket Studies (PAS or 522 PS stage) B. STUDY DESIGN AND CONDUCT 1. For New or Ongoing Studies (IDE study design/early enrollment stage) 2. For Completed Studies (marketing application stage) 3. For Postmarket Studies (PAS or 522 PS stage) V. RECOMMENDATIONS FOR SEX-SPECIFIC STATISTICAL ANALYSIS A. ANALYSIS OF EFFECTS OF SEX ON STUDY OUTCOMES 1. For New or Ongoing Studies (IDE study design/early enrollment stage) 2. For Completed Studies (marketing application stage) 3. For Postmarket Studies (PAS or 522 PS stage) B. INTERPRETATION OF SEX-SPECIFIC DATA 2. RECOMMENDATIONS FOR REPORTING SEX-SPECIFIC INFORMATION IN SUMMARIES AND LABELING A. ENROLLMENT DEMOGRAPHICS, BASELINE CHARACTERISTICS & CO-MORBIDITIES 1. For New or Ongoing Studies (IDE study design/early enrollment stage) 2 ...
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