{"id":198219,"date":"2024-10-19T12:37:07","date_gmt":"2024-10-19T12:37:07","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/aami-14155-2011\/"},"modified":"2024-10-25T05:10:15","modified_gmt":"2024-10-25T05:10:15","slug":"aami-14155-2011","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/aami\/aami-14155-2011\/","title":{"rendered":"AAMI 14155 2011"},"content":{"rendered":"

Addresses the technical aspects of clinical investigations carried out in human subjects to establish the performance and safety of medical devices for regulatory purposes by defining procedures for their design, conduct, recording and reporting.<\/p>\n

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PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
1<\/td>\nANSI\/AAMI\/ISO 14155:2011, Clinical investigation of medical devices for human subjects \u2013 Good clinical practice <\/td>\n<\/tr>\n
2<\/td>\nObjectives and uses of AAMI standards and recommended practices
\n <\/td>\n<\/tr>\n
3<\/td>\nTitle page
\n <\/td>\n<\/tr>\n
4<\/td>\nAAMI Standard
\n
Copyright information
\n <\/td>\n<\/tr>\n
5<\/td>\nContents <\/td>\n<\/tr>\n
7<\/td>\nGlossary of
\nequivalent standards <\/td>\n<\/tr>\n
9<\/td>\nCommittee
\nrepresentation <\/td>\n<\/tr>\n
11<\/td>\nBackground of
\nANSI\/AAMI adoption of ISO 14155:2011 <\/td>\n<\/tr>\n
12<\/td>\n Foreword
\n <\/td>\n<\/tr>\n
13<\/td>\n1 Scope
\n
2 Normative references <\/td>\n<\/tr>\n
14<\/td>\n3
\nTerms and definitions <\/td>\n<\/tr>\n
20<\/td>\n4
\nEthical considerations
4.1
\nGeneral
4.2
\nImproper influence or inducement
4.3
\nCompensation and additional health care
4.4
\nResponsibilities <\/td>\n<\/tr>\n
21<\/td>\n4.5
\nCommunication with the ethics committee (EC)
4.5.1
\nGeneral
4.5.2
\nInitial EC submission
4.5.3
\nInformation to be obtained from the EC
4.5.4
\nContinuing communication with the EC <\/td>\n<\/tr>\n
22<\/td>\n4.5.5
\nContinuing information to be obtained from the EC
4.6
\nVulnerable populations
4.7
\nInformed consent
4.7.1
\nGeneral <\/td>\n<\/tr>\n
23<\/td>\n4.7.2
\nProcess of obtaining informed consent
4.7.3
\nSpecial circumstances for informed consent
4.7.3.1
\nGeneral
4.7.3.2
\nSubject needing legally authorized representatives
4.7.3.3
\nSubject unable to read or write <\/td>\n<\/tr>\n
24<\/td>\n4.7.3.4
\nEmergency treatments
4.7.4
\nInformation to be provided to the subject <\/td>\n<\/tr>\n
26<\/td>\n4.7.5
\nInformed consent signature <\/td>\n<\/tr>\n
27<\/td>\n4.7.6
\nNew information
5 Clinical investigation planning
5.1
\nGeneral
5.2
\nRisk evaluation
5.3
\nJustification for the design of the clinical investigation <\/td>\n<\/tr>\n
28<\/td>\n5.4
\nClinical investigation plan (CIP)
5.5
\nInvestigator’s brochure (IB)
5.6
\nCase report forms (CRFs)
5.7
\nMonitoring plan
5.8
\nInvestigation site selection
5.9
\nAgreement(s) <\/td>\n<\/tr>\n
29<\/td>\n5.10
\nLabeling
5.11
\nData monitoring committee (DMC)
6 Clinical investigation conduct
6.1
\nGeneral
6.2
\nInvestigation site initiation
6.3
\nInvestigation site monitoring <\/td>\n<\/tr>\n
30<\/td>\n6.4
\nAdverse events and device deficiencies
6.4.1
\nAdverse events
6.4.2
\nDevice deficiencies
6.5 Clinical investigation documents and documentation
6.5.1
\nAmendments
6.5.2
\nSubject identification log
6.5.3
\nSource documents <\/td>\n<\/tr>\n
31<\/td>\n6.6 Additional members of the investigation site team
6.7
\nSubject privacy and confidentiality of data
6.8 Document and data control
6.8.1
\nTraceability of documents and data
6.8.2
\nRecording of data <\/td>\n<\/tr>\n
32<\/td>\n6.8.3 Electronic clinical data systems
6.9 Investigational device accountability <\/td>\n<\/tr>\n
33<\/td>\n6.10 Accounting for subjects
6.11 Auditing
7 Suspension, termination and close-out of the clinical investigation
7.1
\nSuspension or premature termination of the clinical investigation
7.1.1
\nProcedure for suspension or premature termination <\/td>\n<\/tr>\n
34<\/td>\n7.1.2
\nProcedure for resuming the clinical investigation after temporary suspension <\/td>\n<\/tr>\n
35<\/td>\n7.2 Routine close-out
7.3 Clinical investigation report <\/td>\n<\/tr>\n
36<\/td>\n7.4 Document retention
8 Responsibilities of the sponsor
8.1
\nClinical quality assurance and quality control <\/td>\n<\/tr>\n
37<\/td>\n8.2
\nClinical investigation planning and conduct
8.2.1
\nSelection of clinical personnel <\/td>\n<\/tr>\n
38<\/td>\n8.2.2 Preparation of documents and materials
8.2.3
\nConduct of clinical investigation <\/td>\n<\/tr>\n
39<\/td>\n8.2.4
\nMonitoring
8.2.4.1
\nGeneral
8.2.4.2
\nQualifications of the monitor
8.2.4.3
\nAssessment of the investigation site
8.2.4.4
\nInitiation of the investigation site <\/td>\n<\/tr>\n
40<\/td>\n8.2.4.5
\nRoutine on-site monitoring visits <\/td>\n<\/tr>\n
41<\/td>\n8.2.4.6
\nClose-out activities
8.2.4.7
\nMonitoring reports
8.2.5
\nSafety evaluation and reporting <\/td>\n<\/tr>\n
42<\/td>\n8.2.6
\nClinical investigation close-out
8.3 Outsourcing of duties and functions <\/td>\n<\/tr>\n
43<\/td>\n8.4
\nCommunication with regulatory authorities
9 Responsibilities of the principal investigator
9.1
\nGeneral
9.2
\nQualification of the principal investigator
9.3
\nQualification of investigation site <\/td>\n<\/tr>\n
44<\/td>\n9.4 Communication with the EC
9.5
\nInformed consent process
9.6
\nCompliance with the CIP <\/td>\n<\/tr>\n
45<\/td>\n9.7
\nMedical care of subjects <\/td>\n<\/tr>\n
46<\/td>\n9.8
\nSafety reporting <\/td>\n<\/tr>\n
47<\/td>\nAnnex A Clinical investigation plan (CIP)
\n
A.1
\nGeneral <\/td>\n<\/tr>\n
48<\/td>\nA.2
\nIdentification and description of the investigational device
A.3
\nJustification for the design of the clinical investigation <\/td>\n<\/tr>\n
49<\/td>\nA.4
\nRisks and benefits of the investigational device and clinical investigation
A.5
\nObjectives and hypotheses of the clinical investigation
A.6
\nDesign of the clinical investigation <\/td>\n<\/tr>\n
51<\/td>\nA.7
\nStatistical considerations
A.8
\nData management
A.9
\nAmendments to the CIP <\/td>\n<\/tr>\n
52<\/td>\nA.10
\nDeviations from clinical investigation plan
A.11
\nDevice accountability
A.12
\nStatements of compliance
A.13
\nInformed consent process
A.14
\nAdverse events, adverse device effects and device deficiencies <\/td>\n<\/tr>\n
53<\/td>\nA.15
\nVulnerable population
A.16
\nSuspension or premature termination of the clinical investigation
A.17
\nPublication policy
A.18
\nBibliography <\/td>\n<\/tr>\n
54<\/td>\nAnnex B Investigator’s brochure (IB)
\n
B.1
\nGeneral
B.2
\nInvestigational device information <\/td>\n<\/tr>\n
55<\/td>\nB.3
\nPreclinical testing
B.4
\nExisting clinical data
B.5
\nRisk management
B.6
\nRegulatory and other references <\/td>\n<\/tr>\n
56<\/td>\nAnnex C Case report forms (CRFs)
\n
C.1
\nGeneral
C.2
\nContent and format <\/td>\n<\/tr>\n
57<\/td>\nC.3
\nProcedural issues <\/td>\n<\/tr>\n
58<\/td>\nAnnex D Clinical investigation report
\n
D.1
\nGeneral
D.2
\nCover page
D.3
\nTable of contents <\/td>\n<\/tr>\n
59<\/td>\nD.4
\nSummary
D.5
\nIntroduction
D.6
\nInvestigational device and methods <\/td>\n<\/tr>\n
60<\/td>\nD.7
\nResults <\/td>\n<\/tr>\n
61<\/td>\nD.8
\nDiscussion and overall conclusions
D.9
\nAbbreviated terms and definitions <\/td>\n<\/tr>\n
62<\/td>\nD.10
\nEthics
D.11
\nInvestigators and administrative structure of clinical investigation
D.12
\nSignature page
D.13
\nAnnexes to the report <\/td>\n<\/tr>\n
64<\/td>\nAnnex E Essential clinical investigation documents
\n <\/td>\n<\/tr>\n
71<\/td>\nAnnex F Adverse event categorization
\n <\/td>\n<\/tr>\n
74<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

ANSI\/AAMI\/ISO 14155:2011 – Clinical investigation of medical devices for human subjects.<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
AAMI<\/b><\/a><\/td>\n2011<\/td>\n74<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":198221,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2654],"product_tag":[],"class_list":{"0":"post-198219","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-aami","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\/198219","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\/198221"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=198219"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=198219"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=198219"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}