{"id":362797,"date":"2024-10-20T01:42:08","date_gmt":"2024-10-20T01:42:08","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bs-en-iso-141552020\/"},"modified":"2024-10-26T02:41:20","modified_gmt":"2024-10-26T02:41:20","slug":"bs-en-iso-141552020","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bs-en-iso-141552020\/","title":{"rendered":"BS EN ISO 14155:2020"},"content":{"rendered":"

This document addresses good clinical practice for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the clinical performance or effectiveness and safety of medical devices.<\/p>\n

For post-market clinical investigations, the principles set forth in this document are intended to be followed as far as relevant, considering the nature of the clinical investigation (see Annex I<\/span>).<\/p>\n

This document specifies general requirements intended to<\/p>\n

    \n
  1. \n

    protect the rights, safety and well-being of human subjects,<\/p>\n<\/li>\n

  2. \n

    ensure the scientific conduct of the clinical investigation and the credibility of the clinical investigation results,<\/p>\n<\/li>\n

  3. \n

    define the responsibilities of the sponsor and principal investigator, and<\/p>\n<\/li>\n

  4. \n

    assist sponsors, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of medical devices.<\/p>\n<\/li>\n<\/ol>\n

    \n
    \n NOTE 1\n <\/div>\n

    Users of this document need to consider whether other standards and\/or national requirements also apply to the investigational device(s) under consideration or the clinical investigation. If differences in requirements exist, the most stringent apply.<\/p>\n<\/div>\n

    \n
    \n NOTE 2\n <\/div>\n

    For Software as a Medical Device (SaMD) demonstration of the analytical validity (the SaMD\u2019s output is accurate for a given input), and where appropriate, the scientific validity (the SaMD\u2019s output is associated to the intended clinical condition\/physiological state), and clinical performance (the SaMD\u2019s output yields a clinically meaningful association to the target use) of the SaMD, the requirements of this document apply as far as relevant (see Reference [ 4<\/span>]). Justifications for exemptions from this document can consider the uniqueness of indirect contact between subjects and the SaMD.<\/p>\n<\/div>\n

    This document does not apply to in vitro<\/i> diagnostic medical devices. However, there can be situations, dependent on the device and national or regional requirements, where users of this document might consider whether specific sections and\/or requirements of this document could be applicable.<\/p>\n

    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\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
    4<\/td>\nEuropean foreword <\/td>\n<\/tr>\n
    5<\/td>\nAnnex ZA (informative) Relationship between this European Standard and the essential requirements of Directive 93\/42\/EEC [OJ L 169] aimed to be covered <\/td>\n<\/tr>\n
    7<\/td>\nAnnex ZB (informative) Relationship between this European Standard and the essential requirements of Directive 90\/385\/EEC [OJ L 189] aimed to be covered <\/td>\n<\/tr>\n
    11<\/td>\nForeword <\/td>\n<\/tr>\n
    13<\/td>\n1 Scope
    2 Normative references
    3 Terms and definitions <\/td>\n<\/tr>\n
    21<\/td>\n4 Summary of good clinical practice (GCP) principles <\/td>\n<\/tr>\n
    22<\/td>\n5 Ethical considerations
    5.1 General
    5.2 Improper influence or inducement
    5.3 Compensation and additional health care <\/td>\n<\/tr>\n
    23<\/td>\n5.4 Registration in publicly accessible database
    5.5 Responsibilities
    5.6 Communication with the ethics committee (EC)
    5.6.1 General
    5.6.2 Initial EC submission <\/td>\n<\/tr>\n
    24<\/td>\n5.6.3 Information to be obtained from the EC
    5.6.4 Continuing communication with the EC
    5.6.5 Continuing information to be obtained from the EC
    5.7 Vulnerable populations <\/td>\n<\/tr>\n
    25<\/td>\n5.8 Informed consent
    5.8.1 General
    5.8.2 Process of obtaining informed consent <\/td>\n<\/tr>\n
    26<\/td>\n5.8.3 Special circumstances for informed consent <\/td>\n<\/tr>\n
    27<\/td>\n5.8.4 Information to be provided to the subject <\/td>\n<\/tr>\n
    29<\/td>\n5.8.5 Informed consent signature
    5.8.6 New information
    6 Clinical investigation planning
    6.1 General
    6.2 Risk management
    6.2.1 General <\/td>\n<\/tr>\n
    30<\/td>\n6.2.2 Investigational device including clinical procedure risks and their disclosure
    6.2.3 Clinical investigation process
    6.3 Justification for the design of the clinical investigation <\/td>\n<\/tr>\n
    31<\/td>\n6.4 Clinical investigation plan (CIP)
    6.5 Investigator’s brochure (IB)
    6.6 Case report forms (CRFs) <\/td>\n<\/tr>\n
    32<\/td>\n6.7 \u200bMonitoring plan <\/td>\n<\/tr>\n
    33<\/td>\n6.8 Investigation site selection
    6.9 Agreement(s)
    6.10 Labelling
    6.11 Data monitoring committee (DMC) <\/td>\n<\/tr>\n
    34<\/td>\n7 Clinical investigation conduct
    7.1 General
    7.2 Investigation site initiation
    7.3 Investigation site monitoring
    7.4 Adverse events and device deficiencies
    7.4.1 Signals requiring immediate action
    7.4.2 Adverse events <\/td>\n<\/tr>\n
    35<\/td>\n7.4.3 Device deficiencies
    7.4.4 Risk assessment process for potentially unacceptable risks <\/td>\n<\/tr>\n
    36<\/td>\n7.5 Clinical investigation documents and documentation
    7.5.1 Amendments
    7.5.2 Subject identification log
    7.5.3 Source documents
    7.6 Additional members of the investigation site team
    7.7 Subject privacy and confidentiality of data <\/td>\n<\/tr>\n
    37<\/td>\n7.8 Document and data control
    7.8.1 Traceability of documents and data
    7.8.2 Recording of data <\/td>\n<\/tr>\n
    38<\/td>\n7.8.3 Electronic clinical data systems
    7.9 Investigational device accountability <\/td>\n<\/tr>\n
    39<\/td>\n7.10 Accounting for subjects
    7.11 Auditing <\/td>\n<\/tr>\n
    40<\/td>\n8 Suspension, termination, and close-out of the clinical investigation
    8.1 Completion of the clinical investigation
    8.2 Suspension or premature termination of the clinical investigation
    8.2.1 Procedure for suspension or premature termination <\/td>\n<\/tr>\n
    41<\/td>\n8.2.2 Procedure for resuming the clinical investigation after temporary suspension
    8.3 Routine close-out
    8.4 Clinical investigation report <\/td>\n<\/tr>\n
    42<\/td>\n8.5 Risk assessment and conclusions
    8.6 Document retention
    9 Responsibilities of the sponsor
    9.1 Clinical quality management <\/td>\n<\/tr>\n
    43<\/td>\n9.2 Clinical investigation planning and conduct
    9.2.1 Selection and training of clinical personnel <\/td>\n<\/tr>\n
    44<\/td>\n9.2.2 Preparation of documents and materials
    9.2.3 Conduct of clinical investigation <\/td>\n<\/tr>\n
    45<\/td>\n9.2.4 \u200bMonitoring <\/td>\n<\/tr>\n
    48<\/td>\n9.2.5 Safety evaluation and reporting
    9.2.6 Clinical investigation close-out <\/td>\n<\/tr>\n
    49<\/td>\n9.3 Outsourcing of duties and functions
    9.4 Communication with regulatory authorities
    10 Responsibilities of the principal investigator
    10.1 General <\/td>\n<\/tr>\n
    50<\/td>\n10.2 Qualification of the principal investigator
    10.3 Qualification of investigation site
    10.4 Communication with the EC <\/td>\n<\/tr>\n
    51<\/td>\n10.5 Informed consent process
    10.6 \u200bCompliance with the CIP <\/td>\n<\/tr>\n
    52<\/td>\n10.7 Medical care of subjects
    10.8 Safety reporting <\/td>\n<\/tr>\n
    53<\/td>\nAnnex A (normative) Clinical investigation plan (CIP) <\/td>\n<\/tr>\n
    62<\/td>\nAnnex B (normative) Investigator’s brochure (IB) <\/td>\n<\/tr>\n
    65<\/td>\nAnnex C (informative) Case report forms (CRFs) <\/td>\n<\/tr>\n
    67<\/td>\nAnnex D (normative) Clinical investigation report <\/td>\n<\/tr>\n
    72<\/td>\nAnnex E (informative) Essential clinical investigation documents <\/td>\n<\/tr>\n
    79<\/td>\nAnnex F (informative) Adverse event categorization <\/td>\n<\/tr>\n
    81<\/td>\nAnnex G (informative) EC responsibilities <\/td>\n<\/tr>\n
    85<\/td>\nAnnex H (informative) Application of ISO 14971 to clinical investigations <\/td>\n<\/tr>\n
    86<\/td>\nAnnex I (informative) Clinical development stages <\/td>\n<\/tr>\n
    91<\/td>\nAnnex J (informative) Clinical investigation audits <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

    Clinical investigation of medical devices for human subjects. Good clinical practice<\/b><\/p>\n\n\n\n\n
    Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
    BSI<\/b><\/a><\/td>\n2020<\/td>\n96<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":362808,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[162,2641],"product_tag":[],"class_list":{"0":"post-362797","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-11-100-20","7":"product_cat-bsi","9":"first","10":"instock","11":"sold-individually","12":"shipping-taxable","13":"purchasable","14":"product-type-simple"},"_links":{"self":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product\/362797","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\/362808"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=362797"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=362797"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=362797"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}