🔥🔥 Don’t Miss Out on Our End of Autumn Sale. If you have any questions, feel free to click the bottom right corner to contact our customer service..

Concat us[email protected]
Shopping Cart

No products in the cart.

🔍
BS ISO 29943-2:2017

BS ISO 29943-2:2017

$189.07

Condoms. Guidance on clinical studies – Female condoms, clinical function studies based on self-reports

Published By Publication Date Number of Pages
BSI 2017 50
PDF Format Searchable Printable Preview Now
Guaranteed Safe Checkout
Category:

If you have any questions, feel free to reach out to our online customer service team by clicking on the bottom right corner. We’re here to assist you 24/7.
Email:[email protected]

PDF Catalog

PDF Pages PDF Title
2 National foreword
7 Foreword
8 Introduction
9 1 Scope
2 Normative references
3 Terms and definitions
11 4 Risk assessment
5 Pilot clinical studies
12 6 Clinical validation investigation
6.1 Objectives of clinical validation investigation
6.2 Outcome measures
6.3 Study subjects
6.3.1 General
13 6.3.2 Enrolment of study subjects
14 6.4 Informed consent
6.5 Test and control condoms
6.5.1 General
15 6.5.2 Test condom
6.5.3 Control condom
6.5.4 Trial duration exceeds one year
16 6.5.5 Sampling of control condoms for bench testing
6.6 Randomization
6.7 Allocation concealment and study masking
6.8 Use of additional lubricant
6.9 Instructions and interactions with study couples
17 6.10 Interviews and data collection
6.10.1 Schedule for interviews and condom distribution
6.10.2 Enrolment interview
18 6.10.3 Individual condom use CRF
6.10.4 Mid-study CRF, crossover trial
19 6.10.5 Compiling data from CRFs
6.11 Data integrity
6.11.1 General
6.11.2 Interactive voice response systems (IVRS)
6.11.3 Mail-in and web-based data reporting
20 6.11.4 Web-based data collection systems, additional suggestions
21 6.12 Control of distribution chain
6.13 Analysis of returned condoms
6.14 Other methodological details
22 6.15 Statistical analysis plan
6.15.1 General
6.15.2 Primary study hypothesis
23 6.15.3 Secondary study hypotheses
6.15.4 Study design
6.15.5 Statistical analysis
24 6.15.6 Additional statistical comments and concerns
6.16 Clinical study results: Review and interpretation
6.16.1 General
6.16.2 Total clinical failure rates for control condom
6.16.3 Non-inferiority
25 6.16.4 Superiority
6.16.5 Safety (adverse events)
6.16.6 What happens if one is unable to conclude non-inferiority?
26 Annex A (informative) Formula for power calculation
27 Annex B (informative) Pilot clinical investigation (sample outline)
29 Annex C (informative) Time and events schedule for individual study subject (sample)
30 Annex D (informative) CRF — Study entry (sample)
33 Annex E (informative) CRF — Mid-study (sample)
35 Annex F (informative) CRF — Single use of female condom (sample)
39 Annex G (informative) CRF — Adverse event (sample)
41 Annex H (informative) Protocol for evaluation of returned used condoms
47 Bibliography

Related products

BS ISO 29943-2:2017
$189.07