AAMI ISO 14155:2020 pdf download – Clinical investigation of medical devices for human subjects – Good clinical practice
1 Scope
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.
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).
This document specifies general requirements intended to
– protect the rights, safety and well-being of human subjects;
– ensure the scientific conduct of the clinical investigation and the credibility of the clinical investigation results;
– define the responsibilities of the sponsor and principal investigator; and
– assist sponsors, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of medical devices.
NOTE 1 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.
NOTE 2 For Software as a Medical Device (SaMD) demonstration of the analytical validity (the SaMD’s output is accurate for a given input), and where appropriate, the scientific validity (the SaMD’s output is associated to the intended clinical condition/physiological state), and clinical performance (the SaMD’s 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]). Justifications for exemptions from this document can consider the uniqueness of indirect contact between subjects and the SaMD [4]. This document does not apply to in vitro 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.
5.8.3.2 Subject needing legally designated representatives
Informed consent may be given by the legally designated representative only if a subject is unable to make the decision to participate in a clinical investigation (e.g. infant, child and juvenile, seriously ill or unconscious subject, or subject with a mental or intellectual disability). In such cases, the subject shall also be informed about the clinical investigation within his/her ability to understand.
5.8.3.3 Subject unable to read or write
Informed consent shall be obtained through a supervised oral process if a subject or legally designated representative is unable to read or write. An independent and impartial witness shall be present throughout the process. The written informed consent form and any other information shall be read aloud and explained to the prospective subject or his/her legally designated representative. Whenever possible, either the subject or his/her legally designated representative shall sign and personally date the informed consent form. The witness shall sign and personally date the informed consent form attesting that the information was accurately explained, and that informed consent was freely given.