{"id":277829,"date":"2024-10-19T18:42:51","date_gmt":"2024-10-19T18:42:51","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bs-iso-29943-22017\/"},"modified":"2024-10-25T15:14:15","modified_gmt":"2024-10-25T15:14:15","slug":"bs-iso-29943-22017","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bs-iso-29943-22017\/","title":{"rendered":"BS ISO 29943-2:2017"},"content":{"rendered":"

PDF Catalog<\/h4>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
2<\/td>\nNational foreword <\/td>\n<\/tr>\n
7<\/td>\nForeword <\/td>\n<\/tr>\n
8<\/td>\nIntroduction <\/td>\n<\/tr>\n
9<\/td>\n1 Scope
2 Normative references
3 Terms and definitions <\/td>\n<\/tr>\n
11<\/td>\n4 Risk assessment
5 Pilot clinical studies <\/td>\n<\/tr>\n
12<\/td>\n6 Clinical validation investigation
6.1 Objectives of clinical validation investigation
6.2 Outcome measures
6.3 Study subjects
6.3.1 General <\/td>\n<\/tr>\n
13<\/td>\n6.3.2 Enrolment of study subjects <\/td>\n<\/tr>\n
14<\/td>\n6.4 Informed consent
6.5 Test and control condoms
6.5.1 General <\/td>\n<\/tr>\n
15<\/td>\n6.5.2 Test condom
6.5.3 Control condom
6.5.4 Trial duration exceeds one year <\/td>\n<\/tr>\n
16<\/td>\n6.5.5 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 <\/td>\n<\/tr>\n
17<\/td>\n6.10 Interviews and data collection
6.10.1 Schedule for interviews and condom distribution
6.10.2 Enrolment interview <\/td>\n<\/tr>\n
18<\/td>\n6.10.3 Individual condom use CRF
6.10.4 Mid-study CRF, crossover trial <\/td>\n<\/tr>\n
19<\/td>\n6.10.5 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 <\/td>\n<\/tr>\n
20<\/td>\n6.11.4 Web-based data collection systems, additional suggestions <\/td>\n<\/tr>\n
21<\/td>\n6.12 Control of distribution chain
6.13 Analysis of returned condoms
6.14 Other methodological details <\/td>\n<\/tr>\n
22<\/td>\n6.15 Statistical analysis plan
6.15.1 General
6.15.2 Primary study hypothesis <\/td>\n<\/tr>\n
23<\/td>\n6.15.3 Secondary study hypotheses
6.15.4 Study design
6.15.5 Statistical analysis <\/td>\n<\/tr>\n
24<\/td>\n6.15.6 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 <\/td>\n<\/tr>\n
25<\/td>\n6.16.4 Superiority
6.16.5 Safety (adverse events)
6.16.6 What happens if one is unable to conclude non-inferiority? <\/td>\n<\/tr>\n
26<\/td>\nAnnex A (informative) Formula for power calculation <\/td>\n<\/tr>\n
27<\/td>\nAnnex B (informative) Pilot clinical investigation (sample outline) <\/td>\n<\/tr>\n
29<\/td>\nAnnex C (informative) Time and events schedule for individual study subject (sample) <\/td>\n<\/tr>\n
30<\/td>\nAnnex D (informative) CRF \u2014 Study entry (sample) <\/td>\n<\/tr>\n
33<\/td>\nAnnex E (informative) CRF \u2014 Mid-study (sample) <\/td>\n<\/tr>\n
35<\/td>\nAnnex F (informative) CRF \u2014 Single use of female condom (sample) <\/td>\n<\/tr>\n
39<\/td>\nAnnex G (informative) CRF \u2014 Adverse event (sample) <\/td>\n<\/tr>\n
41<\/td>\nAnnex H (informative) Protocol for evaluation of returned used condoms <\/td>\n<\/tr>\n
47<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

Condoms. Guidance on clinical studies – Female condoms, clinical function studies based on self-reports<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
BSI<\/b><\/a><\/td>\n2017<\/td>\n50<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":277832,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2641],"product_tag":[],"class_list":{"0":"post-277829","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-bsi","8":"first","9":"instock","10":"sold-individually","11":"shipping-taxable","12":"purchasable","13":"product-type-simple"},"_links":{"self":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product\/277829","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product"}],"about":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/types\/product"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media\/277832"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=277829"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=277829"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=277829"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}