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IMDRF/REGISTRY WG/N33FINAL:2016 Principles of International System of Registries Linked to Other Data Sources and Tools - PDF (873kb)

赵静曼 5/8/2022 浏览 350 IMDRF/REGISTRY WG/N33 世界范围

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Principles of International System of Registries Linked to Other Data Sources and Tools - PDF (873kb)[附网盘链接]由IMDRF Patient Registries Working Group于30 September 2016发布，适用于世界范围。

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Principles of International System of Registries Linked to Other Data Sources and Tools - PDF (873kb)[附网盘链接]
Principles of International System of Registries Linked to Other Data Sources and Tools - PDF (873kb)[附网盘链接](截图)

 

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IMDRF/REGISTRY WG/N33FINAL:2016

1.0 Introduction

The International Medical Device Regulators Forum (IMDRF) Registry Working Group was

created with the purpose of developing:

(1) Essential principles for linking electronic patient, device and outcome registries and/or

related data repositories or identifiers such as Unique Device Identifiers (UDIs),

including the principles behind data access, security, informatics formats, governance

and other key areas related to global regulatory applications for medical device

evaluation; and

(2) Essential principles related to optimal methodologies for analysis of heterogeneous

data sources applied to medical device safety, signal detection, performance and

reliability.

This report focuses on the task described in (1).

2.0 Scope

This document provides information and guidance on:

• Vision for international system of registries linked to other relevant data sources and

tools that would add value to multiple stakeholders including regulators

• Definition and qualifiers that define the impact, value and sustainability of registries

• Successes in building national registries and international collaborations

• Data features and quality requirements for participating registries

• Desirable dimensions of data for assuring analysis validity when linking registries with

other relevant data sources and tools

3.0 References

Krucoff M, Sedrakyan A, Normand ST et al. Bridging Unmet Medical Device Ecosystem Needs

with Strategically Coordinated Registry Networks: An Overview of Recommendations of the

National Medical Device Registry Task Force. In press- JAMA

Methodological guidelines and recommendations for efficient and rational governance of patient

registries. The PARENT cross border PAtient REgistries iNITiative. Submitted for publication.

Sanborn TA, Tcheng JE, Anderson HV, et al. ACC/AHA/SCAI 2014 health policy statement on

structured reporting for the cardiac catheterization laboratory: a report of the American College

of Cardiology Clinical Quality Committee. J Am Coll Cardiol. 2014; 63:2591-623.

Sedrakyan A, Paxton E, Graves S, Love R, Marinac-Dabic D. National and international

postmarket research and surveillance implementation: achievements of the International

Consortium of Orthopaedic Registries initiative. J Bone Joint Surg Am. 2014 Dec 17;96 Suppl

1:1-6.

Tcheng JE, Crowley J, Tomes M, Reed TL, Dudas JM, Thompson KP, Garratt KN, Drozda JP.

Unique Device Identifiers for coronary stent postmarket surveillance and research: a report from

30 September 2016 Page 4 of 28

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