ISO 20916-2019 PDF

Full title and description

ISO 20916:2019 — In vitro diagnostic medical devices — Clinical performance studies using specimens from human subjects — Good study practice. This International Standard specifies principles and general requirements for planning, design, conduct, recording and reporting of clinical performance studies of in vitro diagnostic (IVD) devices that use specimens from human subjects for regulatory and conformity-assessment purposes.

Abstract

ISO 20916:2019 provides guidance on good study practice for clinical performance studies involving human specimens for IVDs. It covers ethical considerations, roles and responsibilities (sponsor, principal investigator), study planning and protocol content, specimen handling and accountability, site selection and initiation, monitoring, data integrity and confidentiality, study close-out and reporting. Analytical performance studies and occupational safety for laboratory personnel are out of scope; the document focuses on clinical performance (how the device performs in the intended use population and by the intended user).

General information

• Status: Published (International Standard).
• Publication date: May 2019.
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 11.100.10 (In vitro diagnostic medical devices).
• Edition / version: Edition 1 (2019).
• Number of pages: 56 pages.

Scope

The standard specifies good study practice principles and general requirements intended to ensure clinical performance studies produce reliable, robust results for assessing clinical performance and safety of IVDs in the intended population and use. It addresses ethical issues, risk evaluation, study design and protocol content, specimen recording and integrity, site selection and monitoring, data security and confidentiality, responsibilities of sponsors and investigators, and report/close-out requirements. The standard does not cover analytical performance studies or provide workplace safety guidance for laboratory personnel; it is aimed at studies performed for regulatory/conformity-assessment purposes (studies performed solely for other purposes such as reimbursement may be outside scope).

Key topics and requirements

• Ethical considerations: informed consent, protection of subject rights, ethics committee involvement and avoidance of undue inducement.
• Study planning: risk evaluation, study objectives, and selection of appropriate study design for clinical performance endpoints.
• Clinical Performance Study Protocol (CPSP): required content and principal investigator responsibilities; case report forms and specimen information recording.
• Specimen management: collection, labelling, accountability, integrity, transport and storage to preserve study validity.
• Study site selection and initiation: qualification, assessment, training and prerequisites for sites and personnel.
• Monitoring and oversight: monitoring plans, routine monitoring, monitoring reports and corrective actions.
• Data security and confidentiality: measures to protect subject and study data integrity and privacy.
• Close-out and reporting: close-out activities, study documentation, and clinical performance study report requirements.
• Roles and responsibilities: clear definition of sponsor, principal investigator, clinical research organizations and other parties involved in the study.

Typical use and users

Used by IVD manufacturers and their clinical/regulatory teams to plan and execute clinical performance studies intended for regulatory submissions or conformity assessment. Other primary users include clinical research organizations (CROs), principal investigators and clinical sites, notified bodies and regulatory authorities, ethics committees, and quality/regulatory professionals working on IVD study governance and documentation.

Related standards

Standards commonly referenced alongside ISO 20916:2019 include ISO 14155 (clinical investigations of medical devices — good clinical practice), ISO 13485 (quality management systems for medical devices), ISO 14971 (risk management for medical devices), ISO 15189 (medical laboratories — requirements for quality and competence) and applicable regional/national regulations and guidance on clinical evidence for IVDs. Regional adoptions (for example EN ISO variants) may also exist.

Keywords

in vitro diagnostic (IVD), clinical performance study, specimens, good study practice, sponsor, principal investigator, informed consent, monitoring, data integrity, study protocol, specimen accountability, regulatory submission.

FAQ

Q: What is this standard?

A: ISO 20916:2019 is an international standard that defines good study practice for clinical performance studies of IVD medical devices that use specimens from human subjects.

Q: What does it cover?

A: It covers ethical considerations, study planning and protocol content, risk evaluation, specimen handling and accountability, site selection and initiation, monitoring, data security, close-out and reporting, and the responsibilities of sponsors and investigators. It does not cover analytical performance studies or workplace safety for laboratory personnel.

Q: Who typically uses it?

A: IVD manufacturers, clinical research organizations, principal investigators and clinical sites, regulatory authorities, notified bodies, ethics committees and quality/regulatory teams involved in clinical performance evidence generation for IVDs.

Q: Is it current or superseded?

A: ISO 20916 was published in 2019 (Edition 1). It remains the reference for good study practice for IVD clinical performance studies; some regions or national bodies may publish adopted versions (for example EN/IS versions) consistent with the ISO text. Users should check with their national standards body or regulatory authority for regional adoptions or harmonized versions applicable to their market.

Q: Is it part of a series?

A: It is a standalone ISO standard focused on clinical performance studies for IVDs, but it is often used alongside related standards such as ISO 14155 (clinical investigations of medical devices), ISO 13485 (quality management), and ISO 14971 (risk management) when planning clinical evidence generation and regulatory submissions.

Q: What are the key keywords?

A: In vitro diagnostic, clinical performance, specimens, study protocol, good study practice, sponsor, principal investigator, monitoring, data integrity, informed consent.