ACRP-MDP key terms

The written document that states the rationale, objectives, design, methodology, monitoring, statistical considerations, and record-keeping requirements for a medical device clinical investigation. It is the device-trial counterpart of a clinical protocol.

A written account of the methods and results of a completed medical device clinical investigation, prepared by the sponsor and used to support regulatory submissions and transparency obligations.

The international standard governing good clinical practice for clinical investigations of medical devices in human subjects, covering ethics, conduct, monitoring, data handling, and documentation. Regulators and sponsors use it as the benchmark for device trial quality.

The harmonized international guideline for good clinical practice in trials of investigational products, setting standards for ethics, protocol conduct, investigator responsibilities, and data quality. Device trials often apply its principles alongside ISO 14155.

An independent body that reviews and approves or disapproves a clinical investigation before it begins, and monitors ongoing conduct, to protect the rights, safety, and well-being of subjects.

A document that explains a study's purpose, procedures, risks, benefits, alternatives, and confidentiality protections, which a prospective subject signs voluntarily before any study-related procedure occurs.

An individual permitted by law to consent on behalf of a prospective subject who cannot give informed consent, such as a guardian or close family member under applicable local rules.

A person whose willingness to volunteer may be unduly influenced by expectation of benefit or fear of reprisal, or who has limited capacity to consent, requiring additional safeguards in enrollment and consent.

A medical device, including a modification or new intended use of an existing device, that is the subject of a clinical investigation and has not yet received marketing authorization for that use.

A regulatory authorization that allows a device to be shipped and used in a clinical investigation to gather safety and effectiveness data before marketing approval. It defines the conditions under which the study may proceed.

An investigational device that presents a potential for serious risk to the health, safety, or welfare of a subject, requiring a formal IDE and full IRB review before study initiation.

An investigational device that does not meet the significant risk definition and may proceed under abbreviated requirements without a formal IDE, though IRB approval and compliance with applicable rules are still required.

The regulatory pathway for high-risk devices requiring demonstration of safety and effectiveness through clinical data before marketing. It is typically supported by a pivotal investigation conducted under an IDE.

A regulatory submission demonstrating that a moderate-risk device is substantially equivalent to a legally marketed predicate device, allowing marketing without a full PMA. Clinical data may be needed to support the equivalence claim.

An already legally marketed device to which a new device is compared in a 510(k) submission to establish substantial equivalence in intended use and technological characteristics.

A definitive clinical investigation designed to provide the primary evidence of safety and effectiveness needed for a marketing application, usually conducted under an approved IDE with prespecified endpoints and adequate statistical power.

An early-stage, often small clinical investigation used to explore device performance, refine procedures, and estimate parameters for a later pivotal study rather than to establish definitive effectiveness.

The objective purpose for which a device is designed, including the target population, clinical condition, and conditions of use, as stated by the manufacturer and evaluated in the investigation.

The specific clinical condition, patient population, and circumstances under which a device is intended to be used, as distinct from the broader general purpose described by intended use.

Any untoward medical occurrence, unintended disease or injury, or untoward clinical sign in subjects, users, or other persons in a clinical investigation, whether or not related to the investigational device.

An adverse event that led to death, serious deterioration in health, or required hospitalization or medical intervention to prevent such outcomes. SAEs require prompt reporting to sponsors and regulators.

An adverse event that is related to the use of an investigational medical device, including events arising from inadequate instructions or user error, and which may require reporting to the sponsor.

An adverse device effect that has resulted in any consequence characteristic of a serious adverse event, such as death, serious deterioration in health, or hospitalization.

A serious adverse device effect whose nature, severity, or outcome was not identified in the current investigator brochure, CIP, or consent materials. USADEs trigger expedited reporting to regulators and ethics committees.

An inadequacy of a medical device in its identity, quality, durability, reliability, safety, or performance, including malfunctions, labeling errors, or user-interface problems, whether or not an adverse event resulted.

A compilation of preclinical and clinical information on an investigational device that is relevant to the investigation, provided to investigators and ethics committees to support safe conduct and informed consent.

The individual, company, institution, or organization that takes responsibility for the initiation, management, and financing of a clinical investigation, including regulatory submissions and oversight of investigators.

An individual who both initiates and conducts a clinical investigation and, under applicable rules, assumes the combined obligations of sponsor and investigator, including regulatory and reporting responsibilities.

The qualified person responsible for conducting the clinical investigation at a site, including protecting subjects, following the CIP, obtaining consent, and ensuring accurate data collection and reporting.

A qualified clinician designated by the principal investigator to perform specific study-related procedures or make important trial decisions, with their role documented in the delegation log.

A site record listing study staff, their qualifications, and the specific tasks each is authorized to perform, demonstrating that the principal investigator has formally delegated duties to trained personnel.

Original records and certified copies, such as hospital charts, laboratory reports, and device logs, from which study data are derived and which support the accuracy of the case report form entries.

A printed or electronic document designed to capture the study data required by the CIP for each subject, which must be consistent with and traceable to source documents.

A formal request from the sponsor or data management team asking site staff to verify, correct, or clarify data entered on a case report form, with the resolution documented for audit purposes.

An on-site or remote review by a sponsor-appointed monitor to verify that the investigation is conducted according to the CIP, applicable regulations, and good clinical practice, and that data are accurate and complete.

A person appointed by the sponsor to oversee the progress of a clinical investigation, verify data against source records, and ensure site compliance with the CIP and regulatory requirements.

The prespecified outcome measure that provides the main evidence for the study's primary objective and on which the sample size and statistical analysis plan are based.

A document that details the planned statistical methods, analysis populations, and handling of missing data before unblinding or analysis, reducing bias and ensuring transparent reporting.

An analysis that includes all randomized subjects in the groups to which they were assigned, regardless of deviations or discontinuation, preserving the benefits of randomization.